68 results on '"Moroni, M."'
Search Results
2. Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons.
- Author
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Antinori A, Marcotullio S, Ammassari A, Andreoni M, Angarano G, Carosi G, Cinque P, d'Arminio Monforte A, Di Perri G, Ensoli B, Ferrazzi E, Galli M, Mastroianni C, Matteelli A, Mazzotta F, Moroni M, Palù G, Puoti M, Puro V, Rizzardini G, Sagnelli E, Suter F, Vella S, and Lazzarin A
- Subjects
- HIV Infections diagnosis, HIV Infections immunology, HIV-1 drug effects, HIV-1 immunology, Italy, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Published
- 2011
3. Key questions in antiretroviral therapy: Italian Consensus Workshop (2005).
- Author
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Carosi G, Torti C, Andreoni M, Angarano G, Antinori A, Bonora S, Borderi M, Castagna A, Castelli F, Cauda R, Chiodo F, D'arminio-Monforte A, De Luca A, Di Perri G, Dianzani F, Filice G, Galli M, Lazzarin A, Maggiolo F, Maserati R, Mazzotta F, Moroni M, Perno CF, and Vullo V
- Subjects
- Humans, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
A panel of leading Italian specialists in infectious diseases, virologists and immunologists met in Rome in 2005 to review critical data and discuss recommendations for each of the key questions in antiretroviral therapy today: When to start treatment? How to start? When to switch? What to switch to? Whether to stop or not to stop treatment, and how? The method of a nominal group meeting was used and recommendations were graded for their strength and quality using a system based on the one adopted by the Infectious Diseases Society of America. Main conclusions are summarized and critically discussed in this consensus statement, as well as some of the most recent data supporting these recommendations are provided.
- Published
- 2006
- Full Text
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4. [13C]Methionine breath test: a novel method to detect antiretroviral drug-related mitochondrial toxicity.
- Author
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Milazzo L, Piazza M, Sangaletti O, Gatti N, Cappelletti A, Adorni F, Antinori S, Galli M, Moroni M, and Riva A
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- Adult, Carbon Dioxide metabolism, Carbon Isotopes administration & dosage, Female, HIV Infections virology, Humans, Male, Methionine administration & dosage, Middle Aged, Anti-HIV Agents adverse effects, Breath Tests methods, Drug-Related Side Effects and Adverse Reactions diagnosis, HIV Infections drug therapy, Mitochondria, Liver drug effects, Reverse Transcriptase Inhibitors adverse effects
- Abstract
Objectives: A major side effect of antiretroviral drugs is nucleoside reverse transcriptase inhibitor (NRTI)-related mitochondrial toxicity, the in vivo diagnosis of which is difficult and not yet standardized. We used the [(13)C]methionine breath test to investigate hepatic mitochondrial oxidation in HIV-1-infected patients receiving antiretroviral therapy., Patients and Methods: The [(13)C]methionine breath test was performed in healthy subjects (n=10), HIV-infected patients on antiretroviral therapy with (n=6) and without (n=15) hyperlactataemia and naive HIV-infected patients (n=11). After oral administration of [(13)C]methionine (2 mg/kg body weight), hepatic methionine metabolism was measured by breath (13)CO(2) enrichment, expressed as delta over baseline (DOB) every 15 min for 120 min by mass spectrometry., Results: The four study groups showed a significant difference in (13)CO(2) exhalation (P=0.001). HIV-infected patients on antiretroviral therapy with normal serum lactate had reduced exhalation of (13)CO(2) compared with healthy subjects (DOB mean peak: 8.82+/-0.62 versus 11+/-0.9, P<0.05). HIV patients with hyperlactataemia had even lower values when compared with patients with normal lactataemia (DOB mean peak: 4.98+/-0.68 versus 8.82+/-0.62, P<0.05)., Conclusions: The [(13)C]methionine breath test possibly showed mitochondrial impairment in antiretroviral-treated HIV-positive patients, particularly with hyperlactataemia. This non-invasive test can be used to monitor drug-related mitochondrial toxicity in vivo and to discover early and asymptomatic damage of the respiratory chain.
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- 2005
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5. IL-7/IL-7 receptor system regulation following IL-2 immunotherapy in HIV-infected patients.
- Author
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Marchetti G, Meroni L, Molteni C, Taskaris G, Gazzola L, Galli M, Clerici M, Moroni M, Franzetti F, and Gori A
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- Antiretroviral Therapy, Highly Active, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, HIV Seropositivity blood, HIV Seropositivity drug therapy, Humans, Interleukin-7 biosynthesis, Lymphocyte Count, Randomized Controlled Trials as Topic, Receptors, Interleukin-7 biosynthesis, Anti-HIV Agents therapeutic use, HIV Seropositivity therapy, Immunologic Factors therapeutic use, Interleukin-2 therapeutic use, Interleukin-7 blood, Receptors, Interleukin-7 blood
- Abstract
Interleukin-2 (IL-2) and IL-7 are the most intriguing molecules in immune-based HIV infection treatment. An in vitro IL-2/IL-7 cross-talk due to IL-2-driven IL-7 receptor-alpha-chain (IL-7R alpha) down-modulation, potentially blocking IL-7 signalling has been described. We investigated the in vivo IL-2 effect on IL-7/IL-7R system, measuring free IL-7, and IL-7R alpha CD4 and CD8 in 12 HIV-positive patients enrolled in a randomized IL-2 trial. Compared to HAART alone, IL-2 induced a parallel expansion in total and naive CD4, TRECs and IL-7 plasma levels, with no IL-7R alpha CD4 and IL-7R alpha CD8 changes (P>0.05), suggesting that in vivo IL-2 boosts IL-7 production without down-modulating IL-7R alpha, preserving IL-7-mediated T-lymphocyte homeostatic regulation. Our data confirm the pivotal role of IL-2 and IL-7 in the regulation of T-lymphocyte homeostasis in HIV infection.
- Published
- 2004
6. 13C-Methionine breath test detects liver mitochondrial impairment in HIV-infected patients with antiretroviral drug-related hyperlactatemia.
- Author
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Milazzo L, Riva A, Sangaletti O, Piazza M, Antinori S, and Moroni M
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- Adult, Anti-HIV Agents therapeutic use, Breath Tests, Carbon Isotopes, Female, Humans, Male, Methionine, Anti-HIV Agents adverse effects, HIV Infections drug therapy, Lactic Acid blood, Mitochondria, Liver drug effects
- Published
- 2004
- Full Text
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7. Correlates of risk of adipose tissue alterations and their modifications over time in HIV-1-infected women treated with antiretroviral therapy.
- Author
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Galli M, Ridolfo AL, Adorni F, Cappelletti A, Morelli P, Massetto B, Piazza M, Gianelli E, Vaccarezza M, Gervasoni C, and Moroni M
- Subjects
- Adolescent, Adult, Anthropometry, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections drug therapy, HIV Infections virology, HIV-1, Humans, Logistic Models, Middle Aged, Multivariate Analysis, Prospective Studies, Risk Factors, Time Factors, Adipose Tissue pathology, Anti-HIV Agents therapeutic use, HIV Infections complications, HIV-Associated Lipodystrophy Syndrome pathology, Reverse Transcriptase Inhibitors therapeutic use
- Abstract
Objective: To assess the correlates of risk of the different types of lipodystrophy and their modifications over time in a cohort of HIV-positive women receiving antiretroviral therapy (ART)., Methods: A consecutive series of HIV-infected women receiving ART was prospectively enrolled between 1 and 31 March 1998, and followed up for 2 years. Adipose tissue alterations (ATAs) and their variations over time were assessed by means of clinical observation and anthropometric measurements, and logistic regression analysis was used to describe the associated risk factors identified by univariate and multivariate analyses., Results: One-hundred-and-seventeen of the 212 women (55.2%) developed ATAs during the 24 months of follow-up. Central adiposity was observed in 95 patients and peripheral lipoatrophy in 91, with 21 patients (9.9%) showing pure lipoatrophy, 26 (12.3%) pure fat accumulation and 70 (33%) combined forms. Only six of the 223 regional adipose tissue alterations identified in 74 patients during the first 12 months of the study had disappeared by month 24. Of the 43 patients who developed breast enlargement during the first 12 months, 11 (25.6%) showed a decrease in breast size during the second year of follow-up that was unrelated to changes in therapy or therapeutic success. The development of ATAs during the first 12 months of follow-up independently correlated with protease inhibitor (PI) use (OR 2.81, P=0.002) but, by the end of the second year of follow-up, the only factor significantly related to the development of ATAs was the overall duration of ART (OR 1.85, P=0.041). The use of PI significantly increased the risk of developing central adiposity during the first 12 months of the study (OR 2.27, P=0.002), whereas the only variable significantly influencing the risk at month 24 was HIV-infection due to intravenous drug use, which proved to be protective (OR 0.53, P=0.043). During the first 12 months of follow-up, the development of peripheral lipoatrophy was significantly associated with stavudine (OR 2.19, P=0.037) and PI use at enrolment (OR 2.27, P=0.023). At the end of the study, the variables associated with peripheral lipoatrophy were stavudine use at enrolment (OR 2.82, P=0.002), ART exposure for >1000 days at enrolment (OR 2.32, P=0.007), a CD4 cell count of >200/microl at enrolment (OR 2.89, P=0.002) and an age of >28 years (OR 1.91, P=0.036). The only factor significantly associated with an increased risk of breast enlargement during the first 12 months of follow-up was PI use (adjusted OR 2.51; 95% CI: 1.16-5.46, P=0.02); however, at month 24, none of the tested variables was associated with a significantly increased risk of this ATA., Conclusions: ATAs (particularly central adiposity) are frequent in women treated with ART, and the different forms have different correlates of risk. Once they have become clinically evident, they generally tend to remain or worsen, and improve in only a small minority of cases. The considerable variations in adipomasty over time are apparently unrelated to changes in ART.
- Published
- 2003
8. Body habitus changes and metabolic alterations in protease inhibitor-naive HIV-1-infected patients treated with two nucleoside reverse transcriptase inhibitors.
- Author
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Galli M, Ridolfo AL, Adorni F, Gervasoni C, Ravasio L, Corsico L, Gianelli E, Piazza M, Vaccarezza M, d'Arminio Monforte A, and Moroni M
- Subjects
- Adult, Aged, Anti-HIV Agents adverse effects, Body Composition drug effects, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections blood, HIV Infections pathology, Humans, Hypercholesterolemia chemically induced, Hyperglycemia chemically induced, Male, Middle Aged, Retrospective Studies, Reverse Transcriptase Inhibitors adverse effects, Stavudine adverse effects, Stavudine therapeutic use, Triglycerides blood, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1, Reverse Transcriptase Inhibitors therapeutic use
- Abstract
Background: Cross-sectional and retrospective surveys suggest that nucleoside reverse transcriptase inhibitors (NRTIs) contribute to the metabolic and morphologic alterations observed in patients on antiretroviral therapy (ART)., Objectives: To assess the risk of developing body habitus changes (BHCs) and metabolic abnormalities in protease inhibitor (PI)-naive HIV-1-infected patients treated with two NRTIs, and the risk associated with each of these drugs., Design: Prospective cohort study., Patients and Methods: The BHCs occurring in 335 patients treated with two NRTIs were evaluated every 3 months. The laboratory tests included determination of CD4 cell counts and the measurement of HIV RNA, serum glucose, cholesterol, and triglyceride levels. Cox proportional hazard models were used to describe the factors associated with the development of BHCs., Results: During a median exposure of 747.5 days, 46 patients (13.7%) developed BHCs: nine fat accumulation alone, 12 fat loss alone, and 25 combined fat loss and accumulation in different body regions. Fat loss alone occurred after a significantly longer median duration of treatment than the other two forms (p =.004). The risk of developing any BHC was significantly higher in female patients (p <.0001). Fat loss was the prevalent alteration in males. Hypertriglyceridemia was observed in 76 patients (22.7%), hypercholesterolemia in 35 (10.5%), and hyperglycemia in 48 (14.3%). The adjusted risk of developing hypertriglyceridemia was higher in the stavudine-treated patients (p =.04) and in those who had previously received ART (p =.02). The only independent factor associated with the development of hypercholesterolemia was to be ART experienced at baseline (p =.02), whereas age was associated with the development of hyperglycemia (p =.0096)., Conclusions: Treatment with NRTIs may be responsible for the same morphologic alterations as those observed in patients treated with PIs. Moreover, altered triglyceride levels are also frequently observed. The different timing of presentation and gender distribution of BHCs suggest that multiple pathogenetic mechanisms are involved.
- Published
- 2002
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9. Primary HIV-1 resistance in recently and chronically infected individuals of the Italian Cohort Naive for Antiretrovirals.
- Author
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Violin M, Forbici F, Cozzi-Lepri A, Velleca R, Bertoli A, Riva C, Giannella S, Manconi PE, Lazzarin A, Pasquinucci S, Tacconi L, Carnevale G, Mazzotta F, Bonazzi L, Montroni M, Chirianni A, Capobianchi M, Ippolito G, Moroni M, Perno CF, and D'Arminio-Monforte A
- Subjects
- Acute Disease, Adult, Amino Acid Substitution, Antimetabolites pharmacology, Antiretroviral Therapy, Highly Active, Chronic Disease, Cohort Studies, Drug Resistance, Viral genetics, Female, HIV Protease Inhibitors pharmacology, HIV Seropositivity, HIV-1 genetics, Humans, Italy epidemiology, Male, Middle Aged, Mutation, Nucleosides pharmacology, Retrospective Studies, Reverse Transcriptase Inhibitors pharmacology, Risk Factors, Anti-HIV Agents pharmacology, HIV-1 drug effects
- Abstract
The risk of acquiring HIV-1 drug resistance at time of infection has become a public health problem following the widespread use of antiretroviral drugs in developed countries. Although a number of studies have reported data regarding the prevalence of HIV-1 primary resistance in developed countries over the past years, limited knowledge is available regarding the proportion of mutations related to drug resistance in antiretroviral naive subjects with chronic HIV-1 disease. In this study, we evaluated the prevalence of mutations in the reverse-transcriptase (RT) and protease region both in a representative group of recently HIV-1 infected subjects (n=68) and a cohort of chronically-infected HIV-positive patients (n=347) enrolled in the Italian Cohort of Antiretroviral Naive patients (I.CO.NA.). In recently infected individuals, the overall prevalence of mutations for nucleoside RTI (NRTIs) was 10/68 (14.7%). The distribution of mutations by calendar year were 0, 1 in 1996, 9, 3 in 1997 and 1, 0 in 1998 for NRTIs and protease inhibitors (PIs) respectively. Thymidine associated mutations were identified in six subjects (8.8%), five of whom had one mutation [41L, 70K (n=2), 215Y] and one had two mutations (67N+219Q). Four subjects (5.9%) showed the changes associated with resistance to lamivudine (184V or 118I). No non nucleoside-RTI (NNRTI) mutations were present in the study period. Primary PIs mutations (two 46L and two 82I) were present in four subjects (5.9%). Of note, mutations related to resistance to more than one class of antiretrovirals were present in one (1.5%). Among patients with chronic infection a large proportion (88.5%) carried no mutations in RT region, 11.5% individuals carried one or more mutations associated with resistance to NRTI (7.8%), or NNRTI (4.9%), with 4 patients carrying mutations to both classes. Among mutations associated with high-level resistance to RTI, T215Y was found in only 2 patients, M184V in 2 cases, T69D in another case, and K103N in only 1 patient, for a total of 6 patients (one carrying both T215Y and M184V) (1.7%). Primary mutations associated with substantial resistance to PIs were found in only 5/347 patients (1.4%); all the other patients carried only secondary mutations. Prevalence of mutations associated with high-level resistance to antiretroviral drugs is stable in recently infected individuals and low in patients with established HIV infection. The potential impact of transmitted mutations on the response to first regimen in individuals carrying transmitted mutations needs to be assessed by prospective studies.
- Published
- 2002
10. Self-reported symptoms and medication side effects influence adherence to highly active antiretroviral therapy in persons with HIV infection.
- Author
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Ammassari A, Murri R, Pezzotti P, Trotta MP, Ravasio L, De Longis P, Lo Caputo S, Narciso P, Pauluzzi S, Carosi G, Nappa S, Piano P, Izzo CM, Lichtner M, Rezza G, Monforte A, Ippolito G, d'Arminio Moroni M, Wu AW, and Antinori A
- Subjects
- Adult, Anti-HIV Agents adverse effects, Antiretroviral Therapy, Highly Active, Confusion chemically induced, Cross-Sectional Studies, Female, Homosexuality, Male, Humans, Italy, Male, Multivariate Analysis, Nausea chemically induced, Odds Ratio, Patient Compliance, Self-Assessment, Surveys and Questionnaires, Treatment Outcome, Vision Disorders chemically induced, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
Objectives: To identify variables predictive of nonadherence to highly active antiretroviral therapy (HAART) and to assess whether self-reported symptoms or medication side effects are related to adherence., Design: Cross-sectional multicenter study Adherence Italian Cohort Naive Antiretrovirals [AdICONA] within the Italian Cohort Naive Antiretrovirals (ICONA)., Methods: Participants receiving HAART completed a 16-item self-administered questionnaire to assess nonadherence in the last 3 days as well as the type and intensity of 24 common HIV- and HAART-related symptoms experienced during the last 4 weeks., Results: From May 1999 to March 2000, 358 persons were enrolled: 22% reported nonadherence and were less likely to have HIV RNA <500 copies/ml (odds ratio = 0.51; 95% confidence interval: 0.31-0.85). Frequency of moderate/severe symptoms or medication side effects in nonadherent participants ranged from 3.6% to 30%. On univariate analysis, nausea, anxiety, confusion, vision problems, anorexia, insomnia, taste perversion, and abnormal fat distribution were significantly associated with nonadherence. Nonadherent persons had a higher mean overall symptom score (12.3 +/- 9.2 versus 8.1 +/- 6.6; p <.001) and mean medication side effect score (2.9 +/- 2.7 versus 1.9 +/- 1.9; p <.001) when compared with adherent participants. In the multivariate analysis, nausea ( p =.003); anxiety ( p =.006); younger age ( p =.007); unemployment ( p <.001); not recalling name, color, and timing of drugs ( p =.009); running out of pills between visits ( p =.002); and being too busy ( p =.03) were independently associated with nonadherence in the last 3 days., Conclusions: In addition to patient characteristics, medication-related variables, and reasons for nonadherence, patient-reported symptoms and medication side effects were significantly associated with adherence to HAART.
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- 2001
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11. Epidemiological spread of drug-resistant HIV-1 strains.
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Balotta C, Violin M, Riva C, Velleca R, Senese D, Rusconi S, Galli M, and Moroni M
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- Drug Resistance, Microbial, Genotype, HIV-1 classification, HIV-1 genetics, Humans, Phenotype, Anti-HIV Agents pharmacology, HIV-1 drug effects
- Published
- 2001
12. Sexual behaviour of heterosexual individuals with HIV infection naive for antiretroviral therapy in Italy.
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Girardi E, Aloisi MS, Serraino D, Ferrara M, Lauria FN, Carballo M, d'Arminio Monforte A, Rezza G, Moroni M, Carosi G, Alessandrini A, Giacobbi D, Cremonini L, Ranieri S, Montroni M, and Ippolito G
- Subjects
- Adult, Cohort Studies, Female, HIV Infections drug therapy, HIV Infections transmission, Humans, Logistic Models, Male, Prospective Studies, Sexual Abstinence, Sexual Partners, Surveys and Questionnaires, Anti-HIV Agents therapeutic use, HIV Infections psychology, Heterosexuality psychology, Risk-Taking, Substance Abuse, Intravenous psychology
- Abstract
Background: Specific information about determinants of sexual behaviour of HIV infected heterosexuals, like injecting drug use (IDU), are essential to design interventions aimed at promoting safer sex practices., Methods: We analysed data on sexual behaviour collected, between March 1997 and March 1999, through a self administered questionnaire among 1050 IDUs and 642 non-IDU heterosexuals enrolled in a prospective multicentre cohort study on the natural history of HIV infection., Results: Among non-IDU heterosexuals, more women (48.5%) than men (25.1%) (p<0.001) reported that they were infected by HIV positive regular partners whose HIV status they were not aware of. Among the 1119 heterosexual males, one fifth reported having had more than 25 sexual partners during their lifetime. Condom use in the last sexual intercourse was more common among heterosexual IDUs (64.9%) than among non-IDU heterosexual males (58.3%) (p=0.05). Heterosexual IDU males were more likely (66.7%) than non-IDU heterosexuals (50.6%) to have an HIV negative partner (p<0.001). Of the 573 heterosexual females studied, 10.2% reported having had more than 25 lifetime sex partners. This proportion was higher among heterosexual IDUs (18.8%) than among non-IDU heterosexuals (4.3%) (p<0.001). Nearly 50% of the women in both groups reported having used a condom in the last intercourse. Almost 57% of heterosexual IDUs had a current HIV negative partner, compared with 34.9% non-IDU heterosexuals (p<0.001). In both sexes, the findings from univariate analysis were confirmed by multiple logistic regression analysis., Conclusions: This study identified some important differences, in both males and females, in sexual lifestyles according to injecting drug use (for example, in terms of HIV negative partners). This observation indicates the need to tailor HIV prevention messages according to history of injecting drug use.
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- 2001
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13. Predictive role of the three-month CD4 cell count in the long-term clinical outcome of the first HAART regimen.
- Author
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d' Arminio Monforte A, Adorni F, Meroni L, Bini T, Testa L, Chiesa E, Melzi S, Rusconi S, Sollima S, Galli M, and Moroni M
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- Acquired Immunodeficiency Syndrome blood, Acquired Immunodeficiency Syndrome drug therapy, Adult, Aged, Female, Follow-Up Studies, Humans, Male, Middle Aged, Predictive Value of Tests, Proportional Hazards Models, Recurrence, Treatment Outcome, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, HIV Infections blood, HIV Infections drug therapy
- Abstract
The aim was to evaluate whether the three-month CD4 cell counts are a reliable predictor of the long-term clinical outcome of HAART-treated patients, by an observational study of 585 patients initiating HAART in a clinical setting. Clinical failure was defined as the occurrence of new or recurrent AIDS-defining events or death, and was analysed by means of intention-to-treat, univariate and multivariate analyses. An adjusted Cox regression model was used to evaluate the effect of three-month CD4+ counts on clinical outcome. Clinical failure occurred in 65 patients (11.1%) during a median follow-up of 31 months (1-65) as a result of new AIDS-defining events (ADEs) in 48 patients, ADE recurrence in six, and death in 11. The mean (median; range) CD4+ counts were 156/microL (155; 4--529) in patients with and 362/microL (326; 18--1162) in patients without clinical failure (P < .0001). Moreover, the proportion of patients with mean CD4+ counts < 200 microL was higher in those experiencing subsequent clinical failure (chi2: 41.11; P< .00001). Multivariate analysis showed that baseline CD4+ counts < 50 microL, HIV-RNA > 100,000 copies/mL and AIDS at baseline predicted failure; after adjusting for three-month CD4+ counts, this marker was the only one independently associated with clinical failure (HR 2.93; 95% Cl: 1.16--7.38). The three-month immunologic response is a reliable predictor of long-term clinical outcome.
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- 2001
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14. Clinical impact of anti retroviral resistance testing: current problems and future directions.
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Rusconi S and Moroni M
- Subjects
- Drug Resistance, Microbial genetics, Drug Therapy, Combination, Forecasting, Genotype, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections virology, HIV-1 genetics, Humans, Microbial Sensitivity Tests, Phenotype, Prognosis, Anti-HIV Agents pharmacology, HIV-1 drug effects
- Published
- 2000
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15. A randomized trial comparing the introduction of ritonavir or indinavir in 1251 nucleoside-experienced patients with advanced HIV infection.
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Floridia M, Tomino C, Bucciardini R, Ricciardulli D, Fragola V, Pirillo MF, Amici R, Giannini G, Galluzzo CM, Andreotti M, Seeber AC, Ammassari A, Cingolani A, Lazzarin A, Scalise G, Cargnel A, Suter F, Milazzo F, Pastore G, Moroni M, Ciammarughi R, Pini R, Carosi G, D'Amato C, Contu L, Concia E, Bonazzi L, Aiuti F, Vigevani G, and Vella S
- Subjects
- Adult, Aged, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, HIV Infections immunology, HIV Infections virology, Humans, Male, Middle Aged, RNA, Viral blood, Treatment Outcome, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1 physiology, Indinavir therapeutic use, Reverse Transcriptase Inhibitors therapeutic use, Ritonavir therapeutic use
- Abstract
ISS-IP1, a multicenter, randomized, 48-week open trial, was designed to compare the introduction of ritonavir or indinavir in patients with previous nucleoside experience and CD4+ cell counts below 50/mm3. Concomitant antiretroviral treatment with nucleoside analogs was allowed. Primary efficacy measures were survival and time to a new AIDS-defining event or death, analyzed through the whole period of observation by the intention-to-treat approach. Primary toxicity measures were time to treatment discontinuation and adverse events, grade at least 3/serious, analyzed by an on-treatment approach. Evaluation-of efficacy also included CD4+ cell and RNA response. The trial enrolled 1251 patients in 5 months. At baseline, mean CD4+ cell count was about 20 cells/mm3 and mean HIV RNA copy number was 4.9 log10/ml in both groups. Overall, 402 patients in the ritonavir group and 250 patients in the indinavir group permanently discontinued the assigned treatment (relative risk, 1.96; 95% CI, 1.68-2.30; p = 0.0001), with most of this difference dependent on a higher number of discontinuation for adverse events in the ritonavir group. After a mean follow-up of 307 days (ritonavir, 304; indinavir, 309), 124 deaths (ritonavir, 61; indinavir, 63; relative risk, 0.96; 95% CI, 0.67-1.36; p = 0.80) and 330 new AIDS-defining events (ritonavir, 170; indinavir, 160; relative risk, 1.05; 95% CI, 0.85-1.31; p = 0.60) were observed. CD4+ cell counts increased in both groups in patients still receiving treatment, with about 100 cells gained by week 24 and 150 cells gained by week 48. Body weight also increased over time in both groups. Analysis of RNA response showed a decrease of 1.5 log10 or higher in both treatment groups. Overall, 400 patients in the ritonavir group and 338 patients in the indinavir group developed at least one grade 3/serious new adverse event during follow-up (relative risk, 1.48; 95% CI, 1.28-1.72; p = 0.0001). Favorable CD4+ cell and RNA responses at 24 and 48 weeks were observed in both groups of patients remaining on treatment. Indinavir showed slightly better effects in sustaining RNA, CD4+ cell, and body weight responses. Ritonavir and indinavir results were comparable in terms of clinical outcome (survival and AIDS-defining events).
- Published
- 2000
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16. Delavirdine in combination with zidovudine in treatment of human immunodeficiency virus type 1-infected patients: evaluation of efficacy and emergence of viral resistance in a randomized, comparative phase III trial. The M/3331/0013B Study Group.
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Joly V, Moroni M, Concia E, Lazzarin A, Hirschel B, Jost J, Chiodo F, Bentwich Z, Love WC, Hawkins DA, Wilkins EG, Gatell AJ, Vetter N, Greenwald C, Freimuth WW, and de Cian W
- Subjects
- Double-Blind Method, Drug Resistance, Microbial, Drug Therapy, Combination, HIV Reverse Transcriptase genetics, HIV-1 drug effects, HIV-1 genetics, Humans, Treatment Outcome, Zidovudine therapeutic use, Anti-HIV Agents therapeutic use, Delavirdine therapeutic use, HIV Infections drug therapy
- Abstract
We compared the activity of delavirdine (DLV) plus zidovudine (AZT) (n = 300) with that of AZT (n = 297) against human immunodeficiency virus type 1 in a randomized, double-blind, placebo-controlled trial. DLV exerted a transient antiviral effect, and mutations for resistance to DLV were found in more than 90% of subjects at week 12. The K103N mutation, which confers nonnucleoside reverse transcriptase inhibitor cross-resistance, was found in 85% of the patients.
- Published
- 2000
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17. Decreasing incidence of CNS AIDS-defining events associated with antiretroviral therapy.
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d'Arminio Monforte A, Duca PG, Vago L, Grassi MP, and Moroni M
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- AIDS Dementia Complex diagnosis, Adult, Anti-HIV Agents adverse effects, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, Follow-Up Studies, HIV Seropositivity diagnosis, Humans, Male, Risk Factors, AIDS Dementia Complex drug therapy, Anti-HIV Agents therapeutic use, HIV Seropositivity drug therapy
- Abstract
The authors enrolled 1,029 patients with CD4 counts = 200/microL and no CNS AIDS-defining events (CNS-AIDS) between January 1993 and December 1998. The primary end point was the first appearance of CNS-AIDS. Three different periods and different antiretroviral regimens were considered. During the median follow-up of 329 days, 144 patients (9.5%) developed CNS-AIDS. The independent predictors were CD4 counts and therapy. All regimens decreased the risk of CNS-AIDS. Highly active antiretroviral therapy led to a 95% risk reduction in comparison with untreated patients.
- Published
- 2000
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18. Discontinuation of primary prophylaxis for Pneumocystis carinii pneumonia and toxoplasmic encephalitis in human immunodeficiency virus type I-infected patients: the changes in opportunistic prophylaxis study.
- Author
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Mussini C, Pezzotti P, Govoni A, Borghi V, Antinori A, d'Arminio Monforte A, De Luca A, Mongiardo N, Cerri MC, Chiodo F, Concia E, Bonazzi L, Moroni M, Ortona L, Esposito R, Cossarizza A, and De Rienzo B
- Subjects
- Acquired Immunodeficiency Syndrome immunology, Adult, Aged, Anti-Infective Agents therapeutic use, Antiprotozoal Agents therapeutic use, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, Follow-Up Studies, HIV Infections immunology, HIV-1, Humans, Italy, Male, Middle Aged, Paris, Time Factors, AIDS-Related Opportunistic Infections prevention & control, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, Pentamidine therapeutic use, Pneumonia, Pneumocystis prevention & control, Toxoplasmosis, Cerebral prevention & control, Trimethoprim, Sulfamethoxazole Drug Combination therapeutic use
- Abstract
A multicenter open, randomized, controlled trial was conducted to determine whether primary prophylaxis for Pneumocystis carinii pneumonia and toxoplasmic encephalitis can be discontinued in patients infected with human immunodeficiency virus type 1 (HIV-1) whose CD4+ T cell counts have increased to >200 cells/mm3 (and who have remained at this level for at least 3 months) as a result of highly active antiretroviral therapy (HAART). Patients were randomized to either the discontinuation arm (i.e., those who discontinued prophylaxis; n=355) or to the continuation arm (n=353); the 2 arms of the study were similar in terms of demographic, clinical, and immunovirologic characteristics. During the median follow-ups of 6.4 months (discontinuation arm) and 6.1 months (continuation arm) and with a total of 419 patient-years, no patient developed P. carinii pneumonia or toxoplasmic encephalitis. The results of this study strongly indicate that primary prophylaxis for P. carinii pneumonia and toxoplasmic encephalitis can be safely discontinued in patients whose CD4+ T cell counts increase to >200 cells/mm3 during HAART.
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- 2000
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19. Susceptibility to PNU-140690 (Tipranavir) of human immunodeficiency virus type 1 isolates derived from patients with multidrug resistance to other protease inhibitors.
- Author
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Rusconi S, La Seta Catamancio S, Citterio P, Kurtagic S, Violin M, Balotta C, Moroni M, Galli M, and d'Arminio-Monforte A
- Subjects
- Drug Resistance, Multiple genetics, Gene Frequency, Genotype, HIV-1 genetics, Humans, Indinavir pharmacology, Microbial Sensitivity Tests, Molecular Sequence Data, Mutation, Phenotype, Ritonavir pharmacology, Saquinavir pharmacology, Sulfonamides, Anti-HIV Agents pharmacology, HIV-1 drug effects, Protease Inhibitors pharmacology, Pyridines pharmacology, Pyrones pharmacology
- Abstract
In our study we examined the anti-human immunodeficiency virus type 1 (anti-HIV-1) activity of a novel HIV-1 protease inhibitor, PNU-140690 (tipranavir), against patient-derived isolates resistant to multiple other protease inhibitors (PIs). The aim of our experiments was to investigate the genotypes and the in vitro phenotypes of drug resistance of PNU-140690. We carried out drug susceptibility tests with peripheral blood mononuclear cells and a fixed amount of infectious virus (1,000 50% tissue culture infective doses) to determine the 50% inhibitory concentration (IC(50)) and IC(90), PCR assays for the detection of drug resistance mutations in RNA in plasma, and direct sequencing of PCR products. Phenotypic resistance to PIs was invariably related to genotypic mutations. The substitutions among the amino acid residues of the protease included L10I, K20R, L24I, M36I, N37D, G48V, I54V, L63P, I64V, A71V, V77I, V82A, I84V, and L90M. Isolates from all of the patients had developed a maximal degree of resistance to indinavir, ritonavir, and nelfinavir (IC(50)s, >0.1 microM). We also compared these mutations with the amino acid changes previously described in association with in vivo tipranavir administration. The mutations included the following: I15V, E35D, N37D, R41K, D60E, and A71T. Infections with IIIB, 14aPre, and N70 were inhibited by an average drug IC(90) of 0.18 +/- 0.02 microM in multiple experiments. The average mean +/- standard error of mean IC(90) for the entire group of multidrug-resistant isolates derived from the mean values for two culture wells with p24 antigen supernatant appeared to be 0.619 +/- 0.055 microM (range, 0.31 to 0.86 microM). Tipranavir retained a sustained antiviral activity against PI-MDR clinical isolates and might be useful in combination regimens with other antiretroviral agents for patients who have already failed other PI-containing therapies.
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- 2000
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20. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naïve patients. I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients.
- Author
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d'Arminio Monforte A, Lepri AC, Rezza G, Pezzotti P, Antinori A, Phillips AN, Angarano G, Colangeli V, De Luca A, Ippolito G, Caggese L, Soscia F, Filice G, Gritti F, Narciso P, Tirelli U, and Moroni M
- Subjects
- Adult, Aged, Anti-HIV Agents adverse effects, Cohort Studies, Drug Therapy, Combination, HIV Protease Inhibitors adverse effects, HIV Protease Inhibitors therapeutic use, HIV Seropositivity drug therapy, Humans, Indinavir therapeutic use, Italy, Male, Middle Aged, Reverse Transcriptase Inhibitors adverse effects, Reverse Transcriptase Inhibitors therapeutic use, Ritonavir therapeutic use, Saquinavir therapeutic use, Time Factors, Treatment Failure, Treatment Refusal, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
Objective: To evaluate the frequency of discontinuation of the first highly active antiretroviral regimen (HAART) and the factors predictive of discontinuing for toxicity and failure in a population-based cohort of HIV-positive individuals in Italy, naïve from antiretrovirals at enrolment., Methods: The study population consisted of individuals who initiated HAART and had at least one follow-up visit. The primary end-points were discontinuation of any component of HAART for drug toxicity and discontinuation for failure. Survival analyses were performed to identify predictive factors for reaching the two end-points., Results: Eight hundred and sixty-two individuals initiated HAART; in 727 of them (84.3%) this consisted of two nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (PI). Over a median follow-up of 45 weeks, 312 patients (36.2%) discontinued therapy: 182 (21.1%) discontinued due to toxicity, 44 (5.1%) due to failure. The probability of discontinuing HAART at 1 year was 25.5% [95% confidence interval (CI), 21.9-28.9] due to toxicity and 7.6% (95% CI, 4.9-1 0.3) due to failure. Independent factors associated with discontinuation for toxicity were: gender [relative hazard (RH) = 0.51; 95% CI, 0.32-0.80 for men versus women], type of treatment (indinavir-containing regimens, RH = 1.94; 95% CI, 1.10-3.41 and ritonavir-containing regimens, RH = 3.83; 95% CI, 2.09-7.03 versus hard-gell saquinavir) and time spent on treatment (RH = 0.89; 95% CI, 0.80-0.98 for each additional month). Discontinuation due to failure was independently associated with the most recent HIV-RNA (RH = 3.20; 95% CI, 1.74-5.88 for log10 copies/ml higher), and with type of treatment (indinavir-containing regimens, RH = 0.21; 95% CI, 0.06-0.78 and ritonavir-containing regimens, RH = 0.23; 95% CI, 0.04-1.26 versus hard-gell saquinavir)., Conclusions: If the current HAART regimen caused no toxicity, less than 10% of naïve patients discontinue their first HAART regimen because of failure after 1 year from starting therapy.
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- 2000
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21. Prevalence of transmitted nucleoside analogue-resistant HIV-1 strains and pre-existing mutations in pol reverse transcriptase and protease region: outcome after treatment in recently infected individuals.
- Author
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Balotta C, Berlusconi A, Pan A, Violin M, Riva C, Colombo MC, Gori A, Papagno L, Corvasce S, Mazzucchelli R, Facchi G, Velleca R, Saporetti G, Galli M, Rusconi S, and Moroni M
- Subjects
- Anti-HIV Agents therapeutic use, Drug Resistance, Microbial genetics, Drug Therapy, Combination, Gene Products, pol genetics, Genotype, HIV Infections drug therapy, HIV Infections immunology, HIV Protease genetics, HIV Reverse Transcriptase genetics, HIV-1 genetics, Humans, Indinavir pharmacology, Indinavir therapeutic use, Phenotype, RNA, Viral blood, Retrospective Studies, Reverse Transcriptase Inhibitors therapeutic use, Ritonavir pharmacology, Ritonavir therapeutic use, Treatment Outcome, Zidovudine pharmacology, Zidovudine therapeutic use, Anti-HIV Agents pharmacology, HIV Infections virology, HIV-1 drug effects, Mutation, Reverse Transcriptase Inhibitors pharmacology
- Abstract
We retrospectively studied 38 Italian recently HIV-1-infected subjects who seroconverted from 1994 to 1997 to investigate: (i) the prevalence of nucleoside reverse transcriptase inhibitors (NRTI)-related mutations at primary infection; (ii) the proportion of naturally occurring mutations in reverse transcriptase (RT) and protease regions of patients naive for non-nucleoside RT inhibitors (NNRTIs) and protease inhibitors (PIs); (iii) the drug-susceptibility to NRTIs and PIs in subjects with NRTI- and/or PI-related mutations; and (iv) the outcome of seroconverters treated with various NRTIs or NRTI/PI regimens. Baseline HIV-1 plasma viraemia and absolute CD4 count at baseline could not be used to distinguish patients with NRTI- and/or PI-related pre-existing mutations from those with wild-type virus (P = 0.693 and P = 0.542, respectively). The frequency of zidovudine-related mutations was 21% in the study period. The response to treatment was not significantly different in subjects with or without genotypic zidovudine-related mutations at primary infection (P = 0.744 for HIV-1 RNA and P = 0.102 for CD4 cells). Some natural variation (2.6%) was present within regions 98-108 and 179-190 of RT involved in NNRTI resistance. The high natural polymorphism in the protease region present in our patients was similar to that reported by others. In our study some PI-associated substitutions, thought to be compensatory in protease enzymatic function, could confer intermediate to high PI-resistance. As discrepancies between genotypic and phenotypic results may exist in recent seroconverters, our data suggest that the role of transmitted NRTI- and PI-resistant variants remain to be fully elucidated in vivo.
- Published
- 2000
22. HIV treatment: an overview.
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Moroni M
- Subjects
- Acquired Immunodeficiency Syndrome immunology, CD4 Lymphocyte Count, Humans, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use
- Published
- 2000
23. CD4 cell counts at the third month of HAART may predict clinical failure.
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d'Arminio Monforte A, Testori V, Adorni F, Castelnuovo B, Bini T, Testa L, Moscatelli G, Chiesa E, Rusconi S, Abeli C, Sollima S, Musicco M, Meroni L, Galli M, and Moroni M
- Subjects
- AIDS-Related Opportunistic Infections immunology, Acquired Immunodeficiency Syndrome complications, Adult, Aged, Drug Therapy, Combination, Female, HIV isolation & purification, HIV Infections immunology, HIV Infections mortality, HIV Infections virology, Humans, Male, Middle Aged, Prognosis, Time Factors, Treatment Failure, Viral Load, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, HIV Infections drug therapy
- Abstract
Objective: To evaluate the influence of immunological and virological markers on clinical outcome in patients receiving their first highly active antiretroviral therapy (HAART) regimen., Design and Methods: Observational study of 585 patients initiating HAART in a clinical setting. Clinical failure was defined as the occurrence of new or recurrent AIDS-defining events or death, and was analysed by means of intention-to-treat, univariate and multivariate analyses. An adjusted Cox regression model was used to evaluate the effect of 3-month CD4 cell counts on clinical outcome., Results: Clinical failure occurred in 55 patients (9.4%) during a median follow-up of 483 days (range 33-1334 days): 45 new AIDS-defining events (ADEs) in 38, ADE recurrence in six, and death in 11. Twenty-four of the 45 new ADEs (53.4%) occurred during the first 3 months of HAART, and 11 of 45 (24.4%) in the presence of CD4 cell counts > 200 x 10(6) cells/l. The mean (median, range) CD4 counts were 144 x 10(6) cells/l (128, 4-529) in patients with and 322 x 10(6) cells/l (288, 14-1162) in patients without clinical failure (P < 0.0001). Moreover, the proportion of patients with mean CD4 cell counts < 200 x 10(6) cells/l was higher in those experiencing subsequent clinical failure (X2 test: 26.75; P < 0.00001). Multivariate analysis showed that baseline CD4 cell counts < 50 x 10(6) cells/l and AIDS at enrolment predicted failure; after adjusting for 3-month CD4 cell counts, this marker was the only one independently associated with clinical failure (hazard risk, 4.79; 95% confidence interval, 1.40-16.47)., Conclusions: The 3-month immunological response is a reliable predictor of long-term clinical outcome.
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- 1999
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24. Evidence of stavudine-related phenotypic resistance among zidovudine-pretreated HIV-1-infected subjects receiving a therapeutic regimen of stavudine plus lamivudine.
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Milazzo L, Rusconi S, Testa L, La Seta-Catamancio S, Galazzi M, Kurtagic S, Citterio P, Gianotto M, Grassini A, Adorni F, d'Arminio-Monforte A, Galli M, and Moroni M
- Subjects
- Anti-HIV Agents pharmacology, Drug Resistance, Microbial genetics, Drug Therapy, Combination, Genotype, HIV Infections virology, Humans, Lamivudine pharmacology, Molecular Sequence Data, Phenotype, Prospective Studies, RNA, Viral chemistry, Reverse Transcriptase Inhibitors pharmacology, Stavudine pharmacology, Zidovudine pharmacology, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1 classification, HIV-1 drug effects, HIV-1 genetics, Lamivudine therapeutic use, Reverse Transcriptase Inhibitors therapeutic use, Stavudine therapeutic use, Zidovudine therapeutic use
- Published
- 1999
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25. CD4+CD7-lymphocyte subset is expanded in HIV-infected patients with low CD4 cell count rescue during highly active antiretroviral therapy.
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Meroni L, Varchetta S, Manganaro D, Moscatelli G, Moroni M, and Galli M
- Subjects
- Adult, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, Drug Therapy, Combination, Humans, Lymphocyte Subsets immunology, Middle Aged, Anti-HIV Agents therapeutic use, Antigens, CD7 immunology, CD4 Antigens immunology, HIV Infections drug therapy, HIV Infections immunology, HIV Protease Inhibitors therapeutic use, Reverse Transcriptase Inhibitors therapeutic use
- Published
- 1999
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26. Redistribution of body fat in HIV-infected women undergoing combined antiretroviral therapy.
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Gervasoni C, Ridolfo AL, Trifirò G, Santambrogio S, Norbiato G, Musicco M, Clerici M, Galli M, and Moroni M
- Subjects
- Adult, Anti-HIV Agents therapeutic use, Cross-Sectional Studies, Drug Therapy, Combination, Female, HIV Protease Inhibitors therapeutic use, Humans, Middle Aged, Reverse Transcriptase Inhibitors therapeutic use, Adipose Tissue metabolism, Anti-HIV Agents adverse effects, HIV Infections drug therapy, HIV Infections metabolism, HIV Protease Inhibitors adverse effects, HIV-1, Reverse Transcriptase Inhibitors adverse effects
- Abstract
Objectives: To investigate the prevalence, metabolic features and risk factors of a particular pattern of fat redistribution (FR), characterized by a progressive enlargement of breast and abdominal girth associated with a wasting of the lower limbs, observed in HIV-infected women treated with combined antiretroviral (ARV) therapy., Design: Cross-sectional study., Setting: Outpatients attending the Institute of Infectious Diseases, University of Milan, Milan, Italy., Patients and Methods: HIV-infected women treated with two or more ARV drugs, observed between December 1997 and February 1998. FR was confirmed by means of a physical examination and dual-energy X-ray absorptiometry (DEXA). The metabolic and endocrinological measurements in patients with FR were compared with those in FR-free women., Results: FR was observed in 32 out of 306 women (10.5%). DEXA revealed more trunk fat (P < 0.01) and less leg fat (P < 0.001) in the patients with FR than in the matched controls. There were no significant differences in laboratory test results between the two groups. All of the FR patients were taking lamivudine-containing regimens; 20 of them were also taking a protease inhibitor (PI). The association of FR with lamivudine-including regimens was statistically significant (P = 0.017). Among the patients taking lamivudine, the risk associated with treatments including PI was 1.8 (95% CI 0.8-3.8, P = 0.12). A total duration of ARV therapy of more than 1000 days was associated with a greater risk of developing FR (OR 10.8; 95% CI 1.4-80.5; P = 0.0207). Stepwise logistic regression analyses indicated that prolonged ARV therapy and a viral load of more than 10000 copies per ml at the beginning of the last ARV regimen were the only variables that significantly and independently correlated with the risk of FR., Conclusions: The observed body modifications are caused by a redistribution of body fat without fat loss that is apparently not associated with hyperlipidemia, altered glucose metabolism or other endocrinological disorders. The development of FR in patients receiving only reverse transcriptase (RT) inhibitors suggests the presence of a PI-independent mechanism that deserves further investigation.
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- 1999
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27. Efficacy and safety of combination therapy with delavirdine and zidovudine: a European/Australian phase II trial.
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Been-Tiktak AM, Boucher CA, Brun-Vezinet F, Joly V, Mulder JW, Jost J, Cooper DA, Moroni M, Gatell JM, Staszewski S, Colebunders R, Stewart GJ, Hawkins DA, Johnson MA, Parkin JM, Kennedy DH, Hoy JF, and Borleffs JC
- Subjects
- Anti-HIV Agents adverse effects, Anti-HIV Agents pharmacokinetics, CD4 Lymphocyte Count, Delavirdine adverse effects, Delavirdine pharmacokinetics, Drug Therapy, Combination, Humans, Reverse Transcriptase Inhibitors adverse effects, Reverse Transcriptase Inhibitors pharmacokinetics, Reverse Transcriptase Inhibitors therapeutic use, Viral Load, Zidovudine adverse effects, Zidovudine pharmacokinetics, Anti-HIV Agents therapeutic use, Delavirdine therapeutic use, HIV Infections drug therapy, Zidovudine therapeutic use
- Abstract
The objective of the study was to investigate the safety and antiviral effect of three delavirdine dose regimens or placebo in combination with zidovudine in patients who were already taking zidovudine. Eighty-nine symptomatic HIV-1 seropositive individuals with CD4 cell counts between 50 and 350 cells/microl were included in this trial The influence of combination therapy on viral susceptibility to both zidovudine and delavirdine was investigated. Death or the occurrence, or re-occurrence of an AIDS-defining illness was considered as a clinical endpoint. The addition of delavirdine to the antiretroviral treatment regimen resulted in a significant, but transient, reduction in virus load, as determined by quantitative RNA measurements. CD4+ cell count did not change significantly. Susceptibility to zidovudine remained unchanged after 12 weeks of combination therapy, while 70% of the patients demonstrated a substantial decrease (> 10-fold) in sensitivity to delavirdine. Two patients suffered from an AIDS-defining disease during the study. No deaths occurred. Generally, the drug appeared to be safe. Skin rash was the most frequently observed adverse event (52%). In most patients the rash either resolved spontaneously or was treated successfully with a short course of antihistamines. The definite place of the compound in the management of HIV disease, in particular when given in combination with other antiretroviral agents, remains to be further explored.
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- 1999
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28. Anti-HIV-1 intermittent drug intensification in HIV-1-infected patients naive for antiretrovirals.
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Rusconi S, Argenteri B, Galli M, d'Arminio-Monforte A, and Moroni M
- Subjects
- Acquired Immunodeficiency Syndrome virology, CD4 Lymphocyte Count, Drug Therapy, Combination, Humans, RNA, Viral blood, Viral Load, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents administration & dosage, HIV-1 drug effects
- Published
- 1999
29. Early increase in cell-associated HIV-1 DNA in patients on highly active antiretroviral therapy.
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Galli M, Balotta C, Meroni L, Colombo MC, Papagno L, Bagnarelli P, Testa L, Varchetta S, Colombo L, Moroni M, d'Arminio Monforte A, Clerici M, and Clementi M
- Subjects
- Adult, CD4 Lymphocyte Count, Drug Therapy, Combination, HIV Infections virology, HIV Protease Inhibitors therapeutic use, Humans, Indinavir therapeutic use, Male, Middle Aged, Proviruses, RNA, Viral blood, Reverse Transcriptase Inhibitors therapeutic use, Viremia virology, Anti-HIV Agents therapeutic use, DNA, Viral analysis, HIV Infections drug therapy, HIV-1 immunology, Viral Load
- Published
- 1998
30. Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection.
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d'Arminio Monforte A, Testa L, Adorni F, Chiesa E, Bini T, Moscatelli GC, Abeli C, Rusconi S, Sollima S, Balotta C, Musicco M, Galli M, and Moroni M
- Subjects
- Adult, CD4 Lymphocyte Count, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections immunology, Humans, Male, Observation, RNA, Viral blood, Treatment Failure, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, HIV-1, Indinavir therapeutic use, Ritonavir therapeutic use, Saquinavir therapeutic use
- Abstract
Objective: To verify the effectiveness of highly active antiretroviral therapy (HAART) and to identify any factors predictive of clinical outcome in a clinical setting., Design: Observational study., Methods: Treatment failure (i.e., the occurrence of new or recurrent AIDS-defining events, death or any definitive discontinuation) and the course of CD4+ cell counts and HIV RNA copies were evaluated in 250 heavily pretreated HIV-infected patients starting HAART [153 with indinavir (IDV), 55 with ritonavir (RTV), 43 with saquinavir (SQV)]. Univariate and multivariate analyses were performed to identify predictors of worse outcome., Results: During a median follow-up of 8 months, 75 patients (30%) had treatment failure because of the occurrence of an AIDS-defining event or death (n = 24), inefficacy (n = 24), or severe intolerance (n = 27). Twenty new and six recurrent AIDS-defining events, and nine deaths occurred (six out of 20 AIDS-defining events and two out of nine deaths within 1 month of treatment). CD4+ counts were above 200 x 10(6)/l at AIDS diagnosis in only two patients. None of the SQV patients, 12 (7.8%) of the IDV patients, and 15 (27.3%) of the RTV-treated patients were considered non-compliant. The SQV-containing regimens independently correlated with treatment failure (relative risk, 2.46; 95% confidence interval, 1.20-5.03; versus IDV). Low compliance partially determined outcome in RTV-treated patients; both severe immunodepression and AIDS at baseline were predictive of treatment failure. There was a 10-fold increase in CD4+ cell counts in the patients treated with IDV and RTV; the best virological outcome occurred in IDV-treated patients, with 68.4% of patients showing undetectable HIV RNA copies after 6 months., Conclusions: HAART was effective in 70% of patients; low compliance and previous AIDS diagnosis represented predictive factors of therapy failure.
- Published
- 1998
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31. Indinavir-related alopecia.
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d'Arminio Monforte A, Testa L, Gianotto M, Gori A, Franzetti F, Sollima S, Bini T, and Moroni M
- Subjects
- Anti-HIV Agents therapeutic use, Humans, Indinavir therapeutic use, Alopecia chemically induced, Anti-HIV Agents adverse effects, HIV Infections drug therapy, Indinavir adverse effects
- Published
- 1998
32. Overview on HIV-1-related drug resistance: from theory to clinical practice.
- Author
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Moroni M, Balotta C, and Rusconi S
- Subjects
- Anti-HIV Agents therapeutic use, HIV Infections virology, Humans, Mutation, Virus Replication drug effects, Virus Replication genetics, Zidovudine pharmacology, Zidovudine therapeutic use, Anti-HIV Agents pharmacology, Drug Resistance, Microbial, HIV Infections drug therapy, HIV-1 drug effects, HIV-1 genetics
- Published
- 1998
33. Sharp drop in the prevalence of human cytomegalovirus leuko-DNAemia in HIV-infected patients following highly active antiretroviral therapy.
- Author
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Gerna G, d'Arminio Monforte A, Zavattoni M, Sarasini A, Testa L, Revello MG, and Moroni M
- Subjects
- CD4 Lymphocyte Count, Cytomegalovirus isolation & purification, DNA, Viral blood, DNA, Viral isolation & purification, HIV isolation & purification, Humans, Leukocytes, Mononuclear virology, Polymerase Chain Reaction, Prevalence, RNA, Viral blood, RNA, Viral isolation & purification, AIDS-Related Opportunistic Infections epidemiology, AIDS-Related Opportunistic Infections virology, Anti-HIV Agents therapeutic use, Cytomegalovirus Infections epidemiology, HIV Infections drug therapy
- Published
- 1998
34. Pentoxifylline improves cell-mediated immunity and reduces human immunodeficiency virus (HIV) plasma viremia in asymptomatic HIV-seropositive persons.
- Author
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Clerici M, Piconi S, Balotta C, Trabattoni D, Capetti A, Fusi ML, Ruzzante S, Longhi R, Colombo MC, Moroni M, and Milazzo F
- Subjects
- Apoptosis, Drug Therapy, Combination, HIV Seropositivity blood, Humans, Immunity, Cellular, Lymphocyte Activation, Lymphocytes drug effects, Polymerase Chain Reaction methods, RNA, Viral blood, T-Lymphocytes, Helper-Inducer immunology, Time Factors, Viremia blood, Viremia drug therapy, Viremia immunology, Adjuvants, Immunologic therapeutic use, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, Cytokines biosynthesis, HIV Seropositivity immunology, HIV Seropositivity therapy, HIV-1 isolation & purification, Lymphocytes immunology, Pentoxifylline therapeutic use
- Abstract
The effects of pentoxifylline on immunologic and virologic parameters were evaluated in 10 human immunodeficiency virus-infected patients not receiving antiretroviral treatment. Patients were asymptomatic, had 300-500 CD4 cells/microL, and received pentoxifylline (1200 mg/day orally) for 4 months. Peripheral blood mononuclear cells were tested before and at five time points during therapy. A transient increase in CD4 cells was observed in 8 of 9 patients, and CD8 cells increased in 7 of 9 patients. These increases were negatively correlated with susceptibility to in vitro mitogen-stimulated apoptotic cell death. Pentoxifylline had a temporary effect on mitogen-stimulated cytokine production; thus, interferon-gamma, interleukin (IL)-2, tumor necrosis factor-alpha, and lymphotoxin increased more than IL-10. Pentoxifylline also potentiated antigen-stimulated IL-2 production and proliferation in 8 of 9 patients and induced significant but transient decreases in plasma viremia in 7 of 9 patients. These preliminary findings suggest that pentoxifylline in vivo has an interesting but temporary influence on both immunologic and virologic parameters.
- Published
- 1997
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35. High-dose nevirapine in previously untreated human immunodeficiency virus type 1-infected persons does not result in sustained suppression of viral replication.
- Author
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de Jong MD, Vella S, Carr A, Boucher CA, Imrie A, French M, Hoy J, Sorice S, Pauluzzi S, Chiodo F, Weverling GJ, van der Ende ME, Frissen PJ, Weigel HM, Kauffmann RH, Lange JM, Yoon R, Moroni M, Hoenderdos E, Leitz G, Cooper DA, Hall D, and Reiss P
- Subjects
- Acquired Immunodeficiency Syndrome virology, Adult, HIV Core Protein p24 analysis, Humans, Middle Aged, Nevirapine, Pyridines adverse effects, Pyridines blood, RNA, Viral analysis, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, HIV-1, Pyridines therapeutic use, Virus Replication drug effects
- Abstract
High-dose nevirapine treatment has been reported to confer sustained antiretroviral effects, despite a rapid development of resistance. The use of this strategy was evaluated in 20 previously untreated human immunodeficiency virus type 1 (HIV-1) p24 antigenemic persons with CD4 cell counts between 100 and 500/mm3. Treatment consisted of 400 mg of nevirapine, after a 2-week lead-in dose of 200 mg. Rash was the most frequently reported adverse event, occurring in 25%. While sustained declines in p24 antigen levels were observed in the majority, serum HIV-1 RNA load and CD4 cell counts returned to baseline values within 12 weeks in virtually all subjects. The resistance-conferring tyrosine-to-cysteine substitution at reverse transcriptase position 181 was detected after 4 weeks in most subjects. These observations suggest that plasma drug levels attained with high-dose nevirapine were not sufficient to inhibit nevirapine-resistant virus, although they were approximately 2-fold higher than reported IC50 values of resistant virus.
- Published
- 1997
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36. Italian multicentre study of didanosine compassionate use in advanced HIV infection. Italian BMS-906 Study Group.
- Author
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d'Arminio Monforte A, Musicco M, Galli M, Paga C, La Regina A, Lazzarin A, Angarano G, Milazzo F, Gritti F, Arlotti M, Mazzotta F, Visco G, Aiuti F, and Moroni M
- Subjects
- AIDS Dementia Complex diagnosis, Acquired Immunodeficiency Syndrome diagnosis, Acquired Immunodeficiency Syndrome mortality, Adolescent, Adult, Aged, Anti-HIV Agents administration & dosage, Anti-HIV Agents adverse effects, CD4 Lymphocyte Count, Didanosine administration & dosage, Didanosine adverse effects, Disease Progression, Drug Resistance, Microbial, Female, HIV Infections immunology, HIV Infections mortality, Humans, Immunocompromised Host, Italy, Male, Middle Aged, Multivariate Analysis, Pancreatitis chemically induced, Pancreatitis diagnosis, Treatment Outcome, Zidovudine adverse effects, Zidovudine therapeutic use, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, Didanosine therapeutic use, HIV Infections drug therapy
- Abstract
The aim of the present study, a multicentre trial of didanosine (ddI) compassionate use, was to identify factors associated with a better outcome in patients given ddI monotherapy. Enrolled were 1047 HIV-positive patients intolerant of and/or unresponsive to zidovudine (ZDV) therapy, with CD4+ cell counts of < 200/microliter or AIDS. Didanosine was given at a dose of 250 mg b.i.d. (patients > or = 60 kg) or 167 mg b.i.d. (patients < 60 kg). Clinical examinations and laboratory tests were performed every two months. Endpoints included death, the occurrence of a new AIDS-defining disease, or permanent discontinuation of ddI for a severe adverse event. At entry, the median CD41 cell count was 47/microliter and the median duration of prior ZDV treatment 19 months; 446 patients (43%) were classified as having AIDS. Severe toxicity occurred in 143 subjects (14%); the frequency of pancreatitis was very low (0.2%). The benefit in terms of CD4+ cell counts was greater for patients whose counts exceeded 100/microliter at entry and remained at this level until month 12 in those patients still receiving treatment. Death and/or new AIDS-defining events were observed in 374 cases (36%) over a median follow-up of eight months. AIDS dementia was observed in 11 patients (1%). Multivariate analysis of survival without disease progression showed that the factors associated with a worse outcome include the severity of immunodepression, a diagnosis of AIDS at entry, and a history of both intolerance of and clinical resistance to ZDV. Surprisingly, the patients who had received previous prolonged treatment with ZDV had a better outcome. In conclusion, severely immunodepressed patients previously administered long-term monotherapy may receive a short-term benefit from being switched to another antiretroviral drug.
- Published
- 1997
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37. A randomized trial (ISS 902) of didanosine versus zidovudine in previously untreated patients with mildly symptomatic human immunodeficiency virus infection.
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Floridia M, Vella S, Seeber AC, Tomino C, Fragola V, Weimer LE, Ricciardulli D, Milazzo F, Gritti FM, Mazzotta F, Ranieri S, Chiodo F, Moroni M, Cargnel A, Bassetti D, Giannini V, Cremoni L, Concia E, Sinicco A, Carosi G, Alberici F, and Dianzani F
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- Acquired Immunodeficiency Syndrome diagnosis, Adult, Anti-HIV Agents adverse effects, Body Weight, CD4 Lymphocyte Count, Didanosine adverse effects, Disease Progression, Female, HIV Core Protein p24 analysis, HIV Core Protein p24 blood, HIV Infections mortality, Humans, Male, Risk, Zidovudine adverse effects, Anti-HIV Agents therapeutic use, Didanosine therapeutic use, HIV Infections drug therapy, Zidovudine therapeutic use
- Abstract
In this multicenter study (ISS 902), 554 previously untreated patients with <500 CD4 cells/mm3 and mildly symptomatic human immunodeficiency virus disease were randomized to receive zidovudine or didanosine (ddI). After a mean follow-up of 20 months, 80 patients (40 zidovudine, 40 ddI) had died and 146 had at least one AIDS-defining event (73 zidovudine, 73 ddI). Overall, no difference was found between treatments with respect to progression to AIDS or death. The analysis of relative risk (RR) of progression over time, however, showed an initially minor risk for zidovudine patients and an inversion in the zidovudine-ddI RR in the second and third years of follow-up. Didanosine showed a greater effect on CD4 cell count response. The two drugs confirmed the toxicity patterns already reported in other trials, with a low occurrence of pancreatitis (ddI 1.3%, zidovudine 0.4%). The overall results suggest that, in this population, zidovudine and ddI monotherapies have comparable long-term clinical efficacy and that more powerful regimens should be preferred.
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- 1997
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38. Loss of antiviral effect owing to zidovudine and lamivudine double resistance in HIV-1-infected patients in an ongoing open-label trial.
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Rusconi S, De Pasquale MP, Milazzo L, Moscatelli G, Bulgheroni E, Citterio P, d'Arminio-Monforte A, Moroni M, and Galli M
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- Acquired Immunodeficiency Syndrome virology, DNA, Viral chemistry, Drug Resistance, Microbial, Drug Therapy, Combination, Humans, Mutation, Phenotype, RNA, Viral blood, RNA, Viral chemistry, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents administration & dosage, HIV-1 genetics, Lamivudine administration & dosage, Zidovudine administration & dosage
- Abstract
In order to compare the resistance pattern to zidovudine plus lamivudine in zidovudine-experienced patients, we studied three HIV-1-infected patients enrolled in NUCB3004, an open-label trial. Over a 24-week follow-up, the patients were studied for drug sensitivity, reverse transcriptase genotype, viral load (HIV-1 RNA level) and viral phenotype (syncytium inducing (SI) or non-syncytium inducing). Virus isolates derived from peripheral blood mononuclear cells (PBMCs) were tested for changes in drug susceptibility. Proviral DNA in the patients' PBMCs and RNA from plasma and culture supernatant were subjected to amplification and sequencing. All three HIV-1 strains showed a decreased susceptibility to either zidovudine or lamivudine after 24 weeks of therapy. The pattern of DNA genotypic resistance to lamivudine in patient A showed a mutation at codon 184 of the reverse transcriptase-encoding gene (methionine to valine). No HIV-1 strains with lamivudine-related mutations in proviral DNA were found among the isolates obtained from patients B and C. In these two patients, the mutation at codon 184 of the reverse transcriptase-encoding gene appeared in RNA, both in plasma and in culture supernatant. Viral phenotyping revealed the maintenance of the SI phenotype at week 24. Two out of the three patients experienced a reduction in HIV-1 RNA levels after 24 weeks of therapy, and in two out of three there was a rebound in viral load at week 28 together with the onset of the codon 184 mutation in RNA. The degree of phenotypic resistance to both zidovudine and lamivudine correlated with the amino acid changes in RNA and the rapid increase in viral load.
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- 1997
39. Viral load, viral phenotype modification, zidovudine susceptibility and reverse transcriptase mutations during the first 6 months of zidovudine monotherapy in HIV-1-infected people.
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Rusconi S, De Pasquale MP, Mainini F, Bulgheroni E, Kurtagic S, Gori A, Violin M, Zanchetta N, Moroni M, Balotta C, and Galli M
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- Acquired Immunodeficiency Syndrome virology, CD4 Lymphocyte Count, HIV Core Protein p24 blood, Humans, Phenotype, Time Factors, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, HIV Reverse Transcriptase genetics, HIV-1 drug effects, Mutation, Zidovudine therapeutic use
- Abstract
We studied 14 zidovudine-naive, HIV-1-infected patients attending an infectious diseases clinic in Milan during zidovudine therapy for 6 months. We monitored CD4 cell counts, immune complex-dissociated p24 antigen, viral phenotype and viral load in plasma. The virus infecting a subset of patients was examined for zidovudine susceptibility and zidovudine resistance-associated mutations. A significant correlation was established between the increase in the CD4 cell count and the decrease in viral load (Spearman's coefficients < -0.5). Patients who were p24 antigen positive had a higher viral load (P < 0.005 at baseline and after 6 months of therapy). Patients with non-syncytium-inducing (NSI) virus had higher CD4 cell counts over time than those with syncytium-inducing (SI) virus. We also examined the viral load in relation to viral phenotype. The median viral load in patients with NSI virus was higher than in SI controls at baseline, but not after 3 and 6 months of therapy. Sequential isolates of HIV-1 were obtained from nine patients and tested for resistance to zidovudine by monitoring the drug susceptibility and the reverse transcriptase-encoding sequence. Amino acid changes at codons 70 and 215 were present in some but not all isolates with zidovudine-resistant phenotype in vitro. It was possible to perform a correlation between zidovudine susceptibility and zidovudine-associated pol gene mutations only at the 6-month time point (Spearman's coefficient = 0.076). SI phenotype was associated with the development of a decreased zidovudine susceptibility. A correlation between zidovudine-associated pol gene mutations and SI phenotype was detected at the 6-month time point.
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- 1996
40. Evolving treatment implementation among HIV- infected pregnant women and their partners: Results from a national surveillance study in Italy, 2001-2015
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Floridia, M., Frisina, V. b., Ravizza, M., Marconi, A. M., Pinnetti, C., Cetin, I., Sansone, M., Molinari, A., Cervi, F., Meloni, A., Luzi, K., Masuelli, G., Tamburrini, E., Ensoli, B., Moroni, M., Lazzarin, A., Sagnelli, E., Antinori, A., Carosi, G., Marcotullio, S., Mazzotta, F., Vella, S., Ammassari, A., Antonucci, G., Andreoni, M., Angarano, G., Armignacco, O., Babudieri, S., Baldelli, F., Bini, T., Bonfanti, Bonora, P., Borderi, S., Bruno, M., Bucciardini, R., Castagna, R, Cattelan, A., Cauda, A. M., Cerioli, R., Chirianni, A., Cingolani, A., Cinque, A., D'Arminio, Monforte, Carli, De, Luca, De, Perri, Di, Pietro, Di, Hamad, El, Errico, I., Ferrazzi, M., Gabrielli, E., Galli, E., Giaquinto, M., Girardi, C., Gori, E., Grossi, A., Guaraldi, P., Liuzzi, G., Caputo, Lo, Maggiolo, S., Malena, F., Maserati, M., Mastroianni, R., Matteelli, C., Morrone, A., Murri, A., Mussini, R., Nasta, C., Oldrini, P., Oleari, M., Orlando, F., Palù, G., Pempinello, G., Perno, R., Prestileo, C., Pompa, T., Puoti, M. G., Puro, M., Rancilio, V., Rasi, L., Rizzardini, G., Savasi, G., Signorini, V. M., Sighinolfi, L., Stagnitta, L., Starace, M., Starnini, F., Sterrantino, G., Suter, G., Tambussi, F., Tavio, G., Torti, M., Tozzi, C., Trotta, V., Vaccher, M. P., Viganò, E., Visintini, A., Vullo, R., Zuccotti, V., Dell'Isola, G. V., Manfredini, S., Parisi, V., Pezzoli, S., M. C., Floridia, M, Frisina, V, Ravizza, M, Marconi, A, Pinnetti, C, Cetin, I, Sansone, M, Molinari, A, Cervi, F, Meloni, A, Luzi, K, Masuelli, G, Tamburrini, E, Ensoli, B, Moroni, M, Lazzarin, A, Sagnelli, E, Antinori, A, Carosi, G, Marcotullio, S, Mazzotta, F, Vella, S, Ammassari, A, Antonucci, G, Andreoni, M, Angarano, G, Armignacco, O, Babudieri, S, Baldelli, F, Bini, T, Bonfanti, P, Bonora, S, Borderi, M, Bruno, R, Bucciardini, R, Castagna, A, Cattelan, A, Cauda, R, Cerioli, A, Chirianni, A, Cingolani, A, Cinque, P, d'Arminio Monforte, A, De Carli, G, De Luca, A, Di Perri, G, Di Pietro, M, El Hamad, I, Errico, M, Ferrazzi, E, Gabrielli, E, Galli, M, Giaquinto, C, Girardi, E, Gori, A, Grossi, P, Guaraldi, G, Liuzzi, G, Lo Caputo, S, Maggiolo, F, Malena, M, Maserati, R, Mastroianni, C, Matteelli, A, Morrone, A, Murri, R, Mussini, C, Nasta, P, Oldrini, M, Oleari, F, Orlando, G, Palu, G, Pempinello, R, Perno, C, Prestileo, T, Pompa, M, Puoti, M, Puro, V, Rancilio, L, Rasi, G, Rizzardini, G, Savasi, V, Signorini, L, Sighinolfi, L, Stagnitta, M, Starace, F, Starnini, G, Sterrantino, G, Suter, F, Tambussi, G, Tavio, M, Torti, C, Tozzi, V, Trotta, M, Vaccher, E, Vigano, A, Visintini, R, Vullo, V, Zuccotti, G, Dell'Isola, S, Manfredini, V, Parisi, S, Pezzoli, M, Zona, S, Floridia, M., Frisina, V., Ravizza, M., Marconi, A. M., Pinnetti, C., Cetin, I., Sansone, M., Molinari, A., Cervi, F., Meloni, A., Luzi, K., Masuelli, G., Tamburrini, E., Ensoli, B., Moroni, M., Lazzarin, A., Sagnelli, E., Antinori, A., Carosi, G., Marcotullio, S., Mazzotta, F., Vella, S., Ammassari, A., Antonucci, G., Andreoni, M., Angarano, G., Armignacco, O., Babudieri, S., Baldelli, F., Bini, T., Bonfanti, P., Bonora, S., Borderi, M., Bruno, R., Bucciardini, R., Castagna, A., Cattelan, A. M., Cauda, R., Cerioli, A., Chirianni, A., Cingolani, A., Cinque, P., d'Arminio Monforte, A., De Carli, G., De Luca, A., Di Perri, G., Di Pietro, M., El Hamad, I., Errico, M., Ferrazzi, E., Gabrielli, E., Galli, M., Giaquinto, C., Girardi, E., Gori, A., Grossi, P., Guaraldi, G., Liuzzi, G., Lo Caputo, S., Maggiolo, F., Malena, M., Maserati, R., Mastroianni, C., Matteelli, A., Morrone, A., Murri, R., Mussini, C., Nasta, P., Oldrini, M., Oleari, F., Orlando, G., Palu, G., Pempinello, R., Perno, C. -F., Prestileo, T., Pompa, M. G., Puoti, M., Puro, V., Rancilio, L., Rasi, G., Rizzardini, G., Savasi, V. M., Signorini, L., Sighinolfi, L., Stagnitta, M., Starace, F., Starnini, G., Sterrantino, G., Suter, F., Tambussi, G., Tavio, M., Torti, C., Tozzi, V., Trotta, M. P., Vaccher, E., Vigano, A., Visintini, R., Vullo, V., Zuccotti, G. V., Dell'Isola, S., Manfredini, V., Parisi, S., Pezzoli, M. C., and Zona, S.
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0301 basic medicine ,Male ,Infectious Disease Transmission ,HIV Infections ,Pre-Exposure Prophylaxi ,Miscarriage ,Cohort Studies ,Pre-exposure prophylaxis ,0302 clinical medicine ,Pregnancy ,Prevalence ,Medicine ,Vertical ,HIV Infection ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,Treatment implementation ,Obstetrics ,Health Policy ,Medicine (all) ,Infectious ,Pregnancy Outcome ,Articles ,3. Good health ,Sexual Partner ,Sexual Partners ,Italy ,Serodiscordant ,Chemoprophylaxis ,Female ,Live birth ,Adolescent ,Adult ,Anti-HIV Agents ,Fertilization ,Humans ,Infectious Disease Transmission, Vertical ,Pre-Exposure Prophylaxis ,Cohort study ,Human ,medicine.medical_specialty ,03 medical and health sciences ,Environmental health ,business.industry ,Public Health, Environmental and Occupational Health ,Anti-HIV Agent ,medicine.disease ,030112 virology ,Pregnancy Complications ,Pregnancy Complications, Infectiou ,Cohort Studie ,business - Abstract
Background The current global and national indications for antiretroviral treatment (ART, usually triple combination therapy) in adolescent and adults, including pregnant women, recommend early ART before immunologic decline, pre-exposure chemoprophylaxis (PrEP), and treatment of HIV-negative partners in serodiscordant couples. There is limited information on the implementation of these recommendations among pregnant women with HIV and their partners. Methods The present analysis was performed in 2016, using data from clinical records of pregnant women with HIV, followed between 2001 and 2015 at hospital or university clinics within a large, nationally representative Italian cohort study. The study period was divided in three intervals of five years each (2001-2005, 2006-2010, 2011-2015), and the analysis evaluated temporal trends in rates of HIV diagnosis in pregnancy, maternal antiretroviral treatment at conception, prevalence of HIV infection among partners of pregnant women with HIV, and proportion of seronegative and seropositive male partners receiving antiretroviral treatment. Results The analysis included 2755 pregnancies in women with HIV. During the three time intervals considered the rate of HIV diagnosis in pregnancy (overall 23.3%), and the distribution of HIV status among male partners (overall 48.7% HIV- negative, 28.6% HIV-positive and 22.8% unknown) remained substantially unchanged. Significant increases were observed in the proportion of women with HIV diagnosed before pregnancy who were on antiretroviral treatment at conception (from 62.0% in 2001-2005 to 81.3% in 2011-2015, P < 0.001), and in the proportion of HIV-positive partners on antiretroviral treatment (from 73.3% in 2001-2005 to 95.8% in 2011-2015, P = 0.002). Antiretroviral treatment was administered in 99.1% of the pregnancies that did not end early because of miscarriage, termination, or intrauterine death, and in 75.3% of those not ending in a live birth. No implementation of antiretroviral treatment was introduced among male HIV-negative partners. Conclusions The results suggest good implementation of antiretroviral treatment among HIV-positive women and their HIV-positive partners, but no implementation, even in recent years, of Pre-Exposure Prophylaxis (PrEP) among uninfected male partners. Further studies should assess the determinants of this occurrence and clarify the attitudes and the potential barriers to PrEP use.
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- 2017
41. Discontinuation of initial antiretroviral therapy in clinical practice: Moving toward individualized therapy
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Di Biagio, Antonio, Cozzi Lepri, Alessandro, Prinapori, Roberta, Angarano, Gioacchino, Gori, Andrea, Quirino, Tiziana, De Luca, Andrea, Costantini, Andrea, Mussini, Cristina, Rizzardini, Giuliano, Castagna, Antonella, Antinori, Andrea, Monforte, Antonella D'arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Cozzi Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Bonora, S., Borderi, M., Calcagno, A., Calza, L., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., GENTILE, Ivan, Di Biagio, Antonio, Cozzi-lepri, Alessandro, Prinapori, Roberta, Angarano, Gioacchino, Gori, Andrea, Quirino, Tiziana, De Luca, Andrea, Costantini, Andrea, Mussini, Cristina, Rizzardini, Giuliano, Castagna, Antonella, Antinori, Andrea, Monforte, Antonella D'arminioA, for the ICONA Foundation Study, Group, Lazzarin, A, Di Biagio, A, Cozzi Lepri, A, Prinapori, R, Angarano, G, Gori, A, Quirino, T, De Luca, A, Costantini, A, Mussini, C, Rizzardini, G, Castagna, A, Antinori, A, Monforte, A, Moroni, M, Andreoni, M, D'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Perno, C, Von Schloesser, F, Viale, P, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bandera, A, Bonfanti, P, Bonora, S, Borderi, M, Calcagno, A, Calza, L, Capobianchi, M, Cingolani, A, Cinque, P, Gianotti, N, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Zaccarelli, M, Fanti, I, Galli, L, Lorenzini, P, Rodano, A, Shanyinde, M, Tavelli, A, Giacometti, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cozzi Lepri, Alessandro, Monforte, Antonella D'arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Cozzi Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Bonora, S., Borderi, M., Calcagno, A., Calza, L., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Gentile, Ivan, Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Cozzi-Lepri, Alessandro, d'Arminio Monforte, Antonella, for the ICONA Foundation Study Group: [.., P Viale, E Vanino, G Verucchi, and ]
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0301 basic medicine ,Male ,Time Factors ,HIV Infections ,0302 clinical medicine ,Quality of life ,HIV Infection ,Pharmacology (medical) ,030212 general & internal medicine ,Precision Medicine ,Antiretroviral therapy ,Discontinuation ,First-line therapy ,HIV-1 ,Resumption treatment ,Single-tablet regimen ,Adolescent ,Adult ,Anti-HIV Agents ,Drug Therapy, Combination ,Female ,Humans ,Middle Aged ,Young Adult ,Infectious Diseases ,Lamivudine ,Clinical Science ,Toxicity ,Combination ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,medicine.drug ,Human ,medicine.medical_specialty ,Time Factor ,Infectious Disease ,Settore MED/17 - MALATTIE INFETTIVE ,NO ,03 medical and health sciences ,Zidovudine ,Pharmacotherapy ,Drug Therapy ,Internal medicine ,medicine ,Antiretroviral therapy Discontinuation First-line therapy HIV-1 Resumption treatment Single-tablet regimen ,Antiretroviral therapy, Discontinuation, First-line therapy, HIV-1, Resumption treatment, Single-tablet regimen ,Proportional hazards model ,business.industry ,Anti-HIV Agent ,030112 virology ,Surgery ,Regimen ,business - Abstract
Supplemental Digital Content is Available in the Text., Background: Study aim was to estimate the rate and identify predictors of discontinuation of first combination antiretroviral therapy (cART) in recent years. Methods: Patients who initiated first cART between January 2008 and October 2014 were included. Discontinuation was defined as stop of at least 1 drug of the regimen, regardless of the reason. All causes of discontinuation were evaluated and 3 main endpoints were considered: toxicity, intolerance, and simplification. Predictors of discontinuation were examined separately for all 3 endpoints. Kaplan–Meier analysis was used for the outcome discontinuation of ≥1 drug regardless of the reason. Cox regression analysis was used to identify factors associated with treatment discontinuation because of the 3 reasons considered. Results: A total of 4052 patients were included. Main reason for stopping at least 1 drug were simplification (29%), intolerance (21%), toxicity (19%), other causes (18%), failure (8%), planned discontinuation (4%), and nonadherence (2%). In a multivariable Cox model, predictors of discontinuation for simplification were heterosexual transmission (P = 0.007), being immigrant (P = 0.017), higher nadir lymphocyte T CD4+ cell (P = 0.011), and higher lymphocyte T CD8+ cell count (P = 0.025); for discontinuation due to intolerance: the use of statins (P = 0.029), higher blood glucose levels (P = 0.050). About toxicity: higher blood glucose levels (P = 0.010) and the use of zidovudine/lamivudine as backbone (P = 0.044). Conclusions: In the late cART era, the main reason for stopping the initial regimen is simplification. This scenario reflects the changes in recommendations aimed to enhance adherence and quality of life, and minimize drug toxicity.
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- 2016
42. CD4/CD8 ratio normalisation and non-AIDS-related events in individuals with HIV who achieve viral load suppression with antiretroviral therapy: An observational cohort study
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Mussini, C, Lorenzini, P, Cozzi Lepri, A, LAPADULA, GIUSEPPE, Marchetti, G, Nicastri, E, Cingolani, A, Lichtner, M, Antinori, A, GORI, ANDREA, Monforte, A, Moroni, M, Andreoni, M, Angarano, G, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Madeddu, G, Maggiolo, F, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti Galli, I, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, E. Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., Mussini, C, Lorenzini, P, Cozzi Lepri, A, Lapadula, G, Marchetti, G, Nicastri, E, Cingolani, A, Lichtner, M, Antinori, A, Gori, A, Monforte, A, Moroni, M, Andreoni, M, Angarano, G, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Madeddu, G, Maggiolo, F, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti Galli, I, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, E. Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cristina, Mussini, Patrizia, Lorenzini, Alessandro, Cozzi-lepri, Giuseppe, Lapadula, Giulia, Marchetti, Emanuele, Nicastri, Antonella, Cingolani, Miriam, Lichtner, Andrea, Antinori, Andrea, Gori, Antonella D'arminio, Monforte, behalf the Icona Foundation Study Group, On, Castagna, Antonella, Mussini, Cristina, Lorenzini, Patrizia, Cozzi-Lepri, Alessandro, Lapadula, Giuseppe, Marchetti, Giulia, Nicastri, Emanuele, Cingolani, Antonella, Lichtner, Miriam, Antinori, Andrea, Gori, Andrea, Monforte, Antonella d'Arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., d'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C.F., von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bonfanti, P., Bonora, S., Borderi, M., Capobianchi, M.R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, Giordano, Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Saracino, A., Cicconi, P., Fanti Galli, I., Lorenzini, P., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., E Manconi, P., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A.P., Rizzardini, G., Ridolfo, A.L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M.C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Guida, M.G., Gargiulo, M., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M.A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Cattelan, A., Sasset, L., Mura, M.S., Rossetti, B., Caramello, P., Orofino, G.C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., and Manfrin, V.
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Adult ,Male ,medicine.medical_specialty ,Anti-HIV Agents ,Epidemiology ,Immunology ,Infectious Diseases ,Virology ,CD4 Lymphocyte Count ,CD4-CD8 Ratio ,Cohort Studies ,Female ,HIV Infections ,HIV-1 ,Humans ,Italy ,Middle Aged ,Viral Load ,Population ,Infectious Disease ,Settore MED/17 - MALATTIE INFETTIVE ,NO ,symbols.namesake ,Acquired immunodeficiency syndrome (AIDS) ,Internal medicine ,epidemiology ,immunology ,infectious diseases ,virology ,medicine ,Poisson regression ,education ,education.field_of_study ,business.industry ,Adult, Anti-HIV Agents, CD4 Lymphocyte Count, CD4-CD8 Ratio, Cohort Studies, Female, HIV Infections, HIV-1, Humans, Italy, Male, Middle Aged, Viral Load ,medicine.disease ,Cohort ,symbols ,business ,Viral load ,Cohort study - Abstract
Background: In patients with HIV, immune reconstitution after antiretroviral therapy (ART) is often incomplete. We assessed the probability of patients reaching a CD4/CD8 ratio of 1 or more after the start of ART and its association with the onset of non-AIDS-defining events and death. Methods: We did an analysis of the ICONA cohort, which recruited treatment-naive patients with HIV in Italy. We included participants in the cohort who started ART, reached an undetectable viral load (â¤80 copies per mL), and had a CD4/CD8 ratio of less than 0·8 at the time of an undetectable viral load. We defined ratio normalisation in patients as two consecutive values of 1 or more. We used Kaplan-Meier curves to estimate the cumulative probability of ratio normalisation. We then used Poisson regression models to identify factors independently associated with normalisation and with progression to non-AIDS-defining events or death. Findings: We included 3236 participants, enrolled between Jan 22, 1997, and Feb 25, 2013. At the start of ART, median CD4/CD8 ratio in our population was 0·39 (IQR 0·26-0·55). 458 (14%) patients reached a CD4/CD8 ratio of 1 or more; the estimated probability of normalisation was 4·4% (95% CI 3·7-5·2) by 1 year from baseline, 11·5% (10·2-13·0) by 2 years, and 29·4% (26·7-32·4) by 5 years. Factors associated with normalisation were high pre-ART CD4 cell counts, a high CD4/CD8 ratio at baseline, and negative cytomegalovirus serological findings. The incidence rate of non-AIDS-defining events for patients with a CD4/CD8 ratio of less than 0·30 (4·2 per 100 patient-years, 95% CI 3·4-5·3) was double that for those with a ratio of 0·30-0·45 (2·3, 2·1-2·5) or more than 0·45 (2·2, 1·7-2·9). A ratio of less than 0·30 was independently associated with an increased risk of non-AIDS-defining events or death compared with one of more than 0·45. Interpretation: Few patients had normalised CD4/CD8 ratios, even though they had viral suppression. Low ratios were associated with increased risk of serious events and deaths. The CD4/CD8 ratio could be used by clinicians to identity patients at risk of non-AIDS-related events. Funding: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, ViiV Italy.
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- 2015
43. Long-term durability of tenofovir-based antiretroviral therapy In relation to the Co-administration of other drug classes in routine clinical practice
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Costarelli, Silvia, Cozzi-Lepri, Alessandro, Lapadula, Giuseppe, Bonora, Stefano, Madeddu, Giordano, Maggiolo, Franco, Antinori, Andrea, Galli, Massimo, Di Perri, Giovanni, Viale, Pierluigi, D'Arminio Monforte, Antonella, Gori, Andrea, Moroni, M., Andreoni, M., Angarano, G., Castelli, F., Cauda, R., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Castagna, A., Ceccherini-Silberstein, F., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bonfanti, P., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Guaraldi, G., Lichtner, M., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Saracino, A., Cicconi, P., Fanti, I., Galli, L., Lorenzini, P., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Guida, M. G., Gargiulo, M., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Cattelan, A., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Costarelli, S, Cozzi Lepri, A, Lapadula, G, Bonora, S, Madeddu, G, Maggiolo, F, Antinori, A, Galli, M, Di Perri, G, Viale, P, D'Arminio Monforte, A, Gori, A, Moroni, M, Andreoni, M, Angarano, G, Castelli, F, Cauda, R, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, Von Schloesser, F, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti, I, Galli, L, Lorenzini, P, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cozzi-Lepri, A, and ICONA Foundation Study, Group
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0301 basic medicine ,Male ,Genetics and Molecular Biology (all) ,Medical Doctors ,Health Care Providers ,Adult ,Anti-HIV Agents ,Drug Therapy, Combination ,Female ,HIV Infections ,HIV Protease Inhibitors ,Humans ,Middle Aged ,Reverse Transcriptase Inhibitors ,Ritonavir ,Tenofovir ,Biochemistry, Genetics and Molecular Biology (all) ,Agricultural and Biological Sciences (all) ,lcsh:Medicine ,Pharmacology ,Toxicology ,Pathology and Laboratory Medicine ,Biochemistry ,MED/17 Malattie infettive ,0302 clinical medicine ,Medicine and Health Sciences ,Medicine ,HIV Infection ,Public and Occupational Health ,030212 general & internal medicine ,Enzyme Inhibitors ,lcsh:Science ,media_common ,Multidisciplinary ,Antimicrobials ,Pharmaceutics ,Medicine (all) ,virus diseases ,Drugs ,Antiretrovirals ,HIV diagnosis and management ,Antivirals ,Vaccination and Immunization ,Reverse Transcriptase Inhibitor ,3. Good health ,Professions ,Combination ,Human ,medicine.drug ,Research Article ,Drug ,medicine.medical_specialty ,Long term durability ,media_common.quotation_subject ,Immunology ,Antiretroviral Therapy ,Microbiology ,NO ,03 medical and health sciences ,Pharmacotherapy ,Antiviral Therapy ,Drug Therapy ,Internal medicine ,Microbial Control ,Virology ,Physicians ,Protease Inhibitors ,HIV Protease Inhibitor ,Toxicity ,business.industry ,lcsh:R ,Anti-HIV Agent ,Biology and Life Sciences ,Adult, Anti-HIV Agents, Drug Therapy, Combination, Female, HIV Infections, HIV Protease Inhibitors, Humans, Male, Middle Aged, Reverse Transcriptase Inhibitors, Ritonavir, Tenofovir ,030112 virology ,Antiretroviral therapy ,Diagnostic medicine ,Discontinuation ,Clinical trial ,Health Care ,People and Places ,Enzymology ,lcsh:Q ,Population Groupings ,Preventive Medicine ,business - Abstract
BACKGROUND: In clinical trials, toxicity leading to tenofovir disoproxil fumarate (TDF) discontinuation is rare (3% by 2 years); however in clinical practice it seems to be higher, particularly when TDF is co-administered with ritonavir-boosted protease inhibitors (PI/r). Aims of this study were to assess the rate of TDF discontinuations in clinical practice and to identify factors associated with the risk of stopping TDF. METHODS: All antiretroviral treatment (ART)-naive patients initiating a TDF-based regimen were selected from the ICONA Foundation Study cohort. The primary outcome was TDF discontinuation regardless of the reason; secondary outcome measures were TDF discontinuation due to toxicity and selective TDF discontinuation (that is, TDF discontinuation or substitution, maintaining unchanged the remaining antiretroviral treatment). RESULTS: 3,618 ART-naïve patients were included: 54% started a PI/r-based and 46% a NNRTI-based based regimen. Two-hundred-seventy-seven patients discontinued TDF and reintroduced ART within 30 days without TDF. The probability of TDF discontinuation regardless of the reason was of 7.4% (95%CI:6.4-8.5) by 2 years and 14.1% (95%CI:12.2-16.1) by 5 years. The 5-year KM estimates in the PI/r vs. NNRTI group were 20.4% vs. 7.6%, respectively (log-rank p = 0.0001), for the outcome of stopping regardless of the reason, and 10.7% vs. 4.7% (p = 0.0001) for discontinuation due to toxicity. PI/r use and lower eGFR were associated with an increased risk of discontinuing TDF. CONCLUSION: In our cohort, the frequency of TDF discontinuations was higher than that observed in clinical trials. Co-administration of TDF with PI/r was associated with an increased rate of TDF discontinuations. Further studies are needed to clarify the mechanisms that might have led to this outcome.
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- 2016
44. Increased risk of virologic failure to the first antiretroviral regimen in HIV-infected migrants compared to natives: Data from the ICONA cohort
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Saracino, A, Lorenzini, P, Lo Caputo, S, Girardi, E, Castelli, F, Bonfanti, P, Rusconi, S, Caramello, P, Abrescia, N, Mussini, C, Monno, L, d'Arminio Monforte, A, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, P. , V, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Puoti, M, Ammassari, A, Balotta, C, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Quiros Roldan, E, A. , S, Cicconi, P, Fanti, I, Galli, L, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Gori, A, Lapadula, G, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., GORI, ANDREA, LAPADULA, GIUSEPPE, Saracino, A, Lorenzini, P, Lo Caputo, S, Girardi, E, Castelli, F, Bonfanti, P, Rusconi, S, Caramello, P, Abrescia, N, Mussini, C, Monno, L, d'Arminio Monforte, A, for the ICONA Foundation Study, Group, Castagna, A, Lazzarin, A, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Perno, C, von Schloesser, F, P., V, Ceccherini Silberstein, F, Cozzi Lepri, A, Puoti, M, Ammassari, A, Balotta, C, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Quiros Roldan, E, A., S, Cicconi, P, Fanti, I, Galli, L, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Saracino, A., Lorenzini, P., Lo Caputo, S., Girardi, E., Castelli, F., Bonfanti, P., Rusconi, S., Caramello, P., Abrescia, N., Mussini, C., Gentile, Ivan, Borgia, Guglielmo, Orlando, Raffaele, Et, A, Monno, L., and d'Arminio Monforte, A.
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0301 basic medicine ,Male ,Pediatrics ,HIV Infections ,Comorbidity ,Kaplan-Meier Estimate ,migrants ,Rate ratio ,0302 clinical medicine ,Antiretroviral Therapy, Highly Active ,HIV Infection ,030212 general & internal medicine ,Treatment Failure ,Transients and Migrants ,virological failure ,Incidence (epidemiology) ,General Medicine ,Middle Aged ,Viral Load ,Antiretroviral therapy ,Virologic failure ,Treatment Outcome ,Infectious Diseases ,Italy ,Cohort ,Female ,HIV ,ICONA ,Migrants ,Adult ,Anti-HIV Agents ,CD4 Lymphocyte Count ,HIV-1 ,Humans ,Risk ,Human ,Microbiology (medical) ,medicine.medical_specialty ,030106 microbiology ,antiretroviral therapy ,Settore MED/17 - MALATTIE INFETTIVE ,NO ,03 medical and health sciences ,Acquired immunodeficiency syndrome (AIDS) ,Transients and Migrant ,medicine ,Highly Active ,business.industry ,Migrant ,Anti-HIV Agent ,Odds ratio ,medicine.disease ,Confidence interval ,Discontinuation ,Regimen ,business - Abstract
Migrant and Italian HIV-infected patients (n = 5773) enrolled in the ICONA cohort in 2004-2014 were compared for disparities in access to an initial antiretroviral regimen and/or risk of virologic failure (VF), and determinants of failure were evaluated. Variables associated with initiating antiretroviral therapy (ART) were analysed. Primary endpoint was time to failure after at least 6 months of ART and was defined as: VF, first of two consecutive virus loads (VL) >200 copies/mL; treatment discontinuation (TD) for any reason; and treatment failure as confirmed VL >200 copies/mL or TD. A Poisson multivariable analysis was performed to control for confounders. Migrants presented significantly lower CD4 counts and more frequent AIDS events at baseline. When adjusting for baseline confounders, migrants presented a lower likelihood to begin ART (odds ratio 0.80, 95% confidence interval (CI) 0.67-0.95, p 0.012). After initiating ART, the incidence VF rate was 6.4 per 100 person-years (95% CI 4.8-8.5) in migrants and 2.7 in natives (95% CI 2.2-3.3). Multivariable analysis confirmed that migrants had a higher risk of VF (incidence rate ratio 1.90, 95% CI 1.25-2.91, p 0.003) and treatment failure (incidence rate ratio 1.16, 95% CI 1.01-1.33, p 0.031), with no differences for TD. Among migrants, variables associated with VF were age, unemployment and use of a boosted protease inhibitor-based regimen versus nonnucleoside reverse transcriptase inhibitors. Despite the use of more potent and safer drugs in the last 10 years, and even in a universal health care setting, migrants living with HIV still present barriers to initiating ART and an increased risk of VF compared to natives.
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- 2016
45. Antiretroviral genotypic resistance in plasma RNA and whole blood DNA in HIV-1 infected patients failing HAART
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Saracino, A, Gianotti, N, Marangi, M, Cibelli, Dc, Galli, A, Punzi, G, Monno, L, Lazzarin, A, Angarano, G, Dini, M, Del Gobbo, R, Montroni, M, Butini, L, Scalise, G, Ancarani, F, Di Cesare, S, Giacometti, A, Biglino, A, Degioanni, M, Paoloni, M, Mariani, R, Calella, G, Pastore, G, Ladisa, N, Mennea, G, Gritti, Fm, Fasullo, G, Chiodo, F, Borderi, M, Carosi, Giampiero, Castelli, Francesco, Torti, Carlo, Uccelli, C, Rizzardini, G, Visoná, R, Salvo, A, Averna, A, Russo, R, Celesia, Bm, Cosentino, S, Rinaldi, E, Pusterla, L, Carnevale, G, Mondello, P, Petrini, C, Ghinelli, F, Sighinolfi, L, Mazzotta, F, Lo Caputo, S, Pierotti, P, Leoncini, F, Sterrantino, Gk, Corsi, P, Pompei, Ag, Di Toro MT, Purificato, F, Indiveri, F, Setti, M, Murdaca, G, Iannessi, A, Cellini, A, Mariani, A, Scasso, A, De Gennaro, M, Chiodera, A, Castelli, P, Maltempo, K, Mongolo, G, Caggese, L, Schlacht, I, Cargnel, A, Atzori, C, Micheli, V, Moroni, M, Bini, T, Marcatto, I, Chiesa, E, Vigevani, G, Argenteri, B, Capetti, A, Esposito, R, Guaraldi, G, Seghetto, B, Chirianni, A, Gargiulo, M, Abrescia, N, D'Abbraccio, M, Busto, T, Marchitelli, C, Santirocchi, M, Abbadessa, V, Mancuso, S, Meneghetti, F, Pranzetti, M, Ferrari, C, Pizzaferri, P, Stagni, G, Di Candilo, F, Petrelli, E, Balducci, M, Menichetti, F, Polidori, M, Tascini, C, Di Carlo, A, Palamara, G, Antinori, A, Liuzzi, G, Aiuti, F, Mezzaroma, I, Pinter, E, Barbone, B, Vullo, V, Massetti, P, Dell'Isola, S, Mura, Ms, Mannazzu, M, Delias, R, Di Giammartino, D, Tarquini, P, Marranconi, F, Ferretto, R, Caramello, P, Orofino, Gc, Cimino, T, Bramato, C, Di Perri, G, Sinicco, A, Zeme, D, Bonora, S, Trentini, L, Soranzo, Ml, Macor, A, Salassa, B, Branz, F, Delle Foglie, P, Vaglia, A, Rossi, Mc, Ciccone, L, Panzolli, L, Grossi, P, Giola, M, Raise, E, Narne, E, Poggio, A, Demin, F, Mondino, V, Serpelloni, G, Malena, M, Bosco, O., Saracino, A, Gianotti, N, Marangi, M, Cibelli, D, Galli, A, Punzi, G, Monno, L, Lazzarin, A, Angarano, G, and Mancuso, S
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Anti-HIV Agents ,DNA Mutational Analysis ,Molecular Sequence Data ,Proviral DNA ,HIV Infections ,HAART failure ,medicine.disease_cause ,DNA Mutational Analysi ,chemistry.chemical_compound ,HIV Protease ,Proviruses ,Antiretroviral Therapy, Highly Active ,Virology ,Drug Resistance, Viral ,medicine ,Humans ,Multicenter Studies as Topic ,HIV Infection ,Treatment Failure ,Genotyping ,Randomized Controlled Trials as Topic ,COLD-PCR ,Mutation ,Plasma RNA ,biology ,Proviruse ,Sequence Analysis, RNA ,Anti-HIV Agent ,RNA ,Sequence Analysis, DNA ,biology.organism_classification ,HIV Reverse Transcriptase ,Reverse transcriptase ,Antiretroviral genotypic resistance ,Infectious Diseases ,chemistry ,DNA, Viral ,Lentivirus ,Immunology ,HIV-1 ,RNA, Viral ,DNA ,antiretroviral genotypic resistance ,haart failure ,hiv-1 ,plasma rna ,proviral dna ,Human - Abstract
The extent to which HIV-1 proviral DNA mutations cause clinically relevant antiretroviral resistance is still controversial. Paired plasma HIV-1 RNA and whole blood DNA were compared in patients failing HAART to investigate if the additional knowledge of archived mutations could improve the selection of potentially active drugs. Seventy-three HIV-1-infected patients with first/second HAART failure were studied before starting a new regimen based on RNA genotyping. Follow-up data after a 12-week therapy were available. DNA genotyping was retrospectively performed on stored whole blood samples and mutational profiles were compared to those from RNA. The mean number of IAS pol mutations was significantly higher in RNA (4.45 ± 2.76) than in DNA (2.88 ± 2.47) (P < 0.001). DNA genotyping provided a 6% increase in detection of resistance-associated mutations. Among 64/73 patients showing discordant DNA/RNA profiles, 54 (84%) also differed for predicted active drugs. 16/73 (22%) patients had ≥1 mutation revealed by DNA genotyping alone, probably affecting therapy success in 2/16. However, neither RNA/DNA discordance nor detection of isolated DNA mutations were statistically associated with outcome. In conclusion, plasma RNA remains the elective choice for HIV genotyping in patients with therapy failure, even if the detection of proviral resistance-associated mutations, not simultaneously found in RNA, is a frequent event. Therefore, in some cases DNA plus RNA genotyping might assist in choosing more accurately subsequent antiretroviral regimens. © 2008 Wiley-Liss, Inc.
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- 2008
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46. Pregnancy Outcomes Among ART-Naive and ART-Experienced HIV-Positive Women: Data From the ICONA Foundation Study Group, Years 1997-2013
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Moroni, M, Andreoni, M, Angarano, G, Antinori, A, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, CF, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, MR, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantin, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, PE, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, AP, Rizzardini, G, Ridolfo, AL, Piolini, R, Salpietro, S, Carenzi, L, Moioli, MC, Tincati, C, Puzzolante, C, Gori, A, Abrescia, N, Chirianni, A, Guida, MG, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, MA, Vullo, V, d'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, MS, Rossetti, B, Caramello, P, Orofino, GC, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., GORI, ANDREA, d'Arminio Monforte, Antonella, Galli, Laura, Lo Caputo, Sergio, Lichtner, Miriam, Pinnetti, Carmela, Bobbio, Nicoletta, Francisci, Daniela, Costantini, Andrea, Cingolani, Antonella, Castelli, Francesco, Girardi, Enrico, Castagna, Antonella, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantin, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, and Manfrin, V
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Pediatrics ,Multivariate analysis ,Infectious Disease Transmission ,Protease Inhibitor ,Human immunodeficiency virus (HIV) ,HIV Infections ,medicine.disease_cause ,Retrospective Studie ,Pregnancy ,Antiretroviral Therapy, Highly Active ,Vertical ,HIV Infection ,Pharmacology (medical) ,Viral ,Pregnancy Complications, Infectious ,Multivariate Analysi ,ART experienced ,ART naives ,Detectable viral load ,Preterm delivery ,Adult ,Anti-HIV Agents ,CD4 Lymphocyte Count ,Female ,Humans ,Infant, Newborn ,Infectious Disease Transmission, Vertical ,Italy ,Multivariate Analysis ,Protease Inhibitors ,RNA, Viral ,Retrospective Studies ,Viral Load ,Pregnancy Outcome ,Infectious Diseases ,Infectious ,Cohort ,Viral load ,Human ,medicine.medical_specialty ,Antiretroviral Therapy ,Settore MED/17 - MALATTIE INFETTIVE ,NO ,medicine ,Highly Active ,Pregnancy outcomes ,business.industry ,Anti-HIV Agent ,Infant ,Retrospective cohort study ,medicine.disease ,Newborn ,Antiretroviral therapy ,Pregnancy Complications ,Immunology ,Pregnancy Complications, Infectiou ,RNA ,business - Abstract
Background: We analyzed antiretroviral therapy (ART) regimens and pregnancy outcomes in naive and ART-experienced HIV-positive women from Italian Cohort Naive Antiretrovirals cohort and investigated frequency and predictors of detectable viral load (VL) at delivery. Methods: All pregnancies resulting in live births were included. Based on ART at the beginning of pregnancy, pregnancies were allocated either to the ART-naive or ART-experienced group. Analyses were stratified according to calendar periods. Multivariate logistic regression was used to describe predictors of detectable VL at delivery. Results: One hundred fifty-eight of 2862 women experienced 169 pregnancies (88 in naives and 81 in 70 ART-experienced women). ART regimens varied according to calendar periods; mono-dual combination regimens progressively decreased over time (P value for trend 50 copies per milliliter at pregnancy ascertainment (adjusted odds ratio: 7.1, 95% confidence interval: 1.9 to 33.3, P = 0.006). Nevertheless, no cases of vertical transmission were diagnosed. Preterm birth rate of 17.3% (11.9% vs 22.6% naive and ART experienced, P = 0.1) was reported; this was not associated with ART duration or protease inhibitor-including regimens; 27.2% of infants had
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- 2014
47. Cumulative and current exposure to potentially nephrotoxic antiretrovirals and development of chronic kidney disease in HIV-positive individuals with a normal baseline estimated glomerular filtration rate: a prospective international cohort study
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Steering, D, Powderly, B, Shortman, N, Moecklinghoff, C, Reilly, G, Franquet, X, Ryom, L, Hatleberg, Ci, Sabin, Ca, Kamara, D, Smith, C, Phillips, A, Mocroft, A, Bojesen, A, Grevsen, A, Matthews, C, Raben, D, Lundgren, Jd, Brandt, Rs, Rickenbach, M, Fanti, I, Hillebreght, M, Zaheri, S, Gras, L, Pernot, E, Mourabi, J, Sundström, A, Delforge, M, Fontas, E, Torres, F, Mcmanus, H, Wright, S, Kristensen, D, Sjøl, A, Meidahl, P, Helweg-Larsen, J, Schmidt Iversen, J, Kirk, O, Reiss, P, Smit, C, Ross, M, Fux, Ca, Morlat, P, Moranne, O, Kamara, Da, Weber, R, Pradier, C, Friis-Møller, N, Kowalska, J, Sabin, C, Law, M, d'Arminio Monforte, A, Dabis, F, Bruyand, M, Bonnet, F, Bower, M, Fätkenheuer, G, Donald, A, Grulich, A, Prins, Jm, Kuijpers, Tw, Scherpbier, Hj, van der Meer JT, Wit, Fw, Godfried, Mh, van der Poll, T, Nellen, Fj, Geerlings, Se, van Vugt, M, Pajkrt, D, Bos, Jc, Wiersinga, Wj, van der Valk, M, Goorhuis, A, Hovius, Jw, van Eden, J, Henderiks, A, van Hes AM, Mutschelknauss, M, Nobel, He, Pijnappel, Fj, Westerman, Am, Jurriaans, S, Back, Nk, Zaaijer, Hl, Berkhout, B, Cornelissen, Mt, Schinkel, Cj, Thomas, Xv, De Ruyter Ziekenhuis, A, van den Berge, M, Stegeman, A, Baas, S, de Looff, L, Versteeg, D, Pronk, Mj, Ammerlaan, Hs, Korsten-Vorstermans, Em, de Munnik ES, Jansz, Ar, Tjhie, J, Wegdam, Mc, Deiman, B, Scharnhorst, V, Kinderziekenhuis, E, van der Plas, A, Weijsenfeld, Am, van der Ende ME, de Vries-Sluijs TE, van Gorp EC, Schurink, Ca, Nouwen, Jl, Verbon, A, Rijnders, Bj, Bax, Hi, Hassing, Rj, van der Feltz, M, Bassant, N, van Beek JE, Vriesde, M, van Zonneveld LM, de Oude-Lubbers, A, van den Berg-Cameron HJ, Bruinsma-Broekman, Fb, de Groot, J, de Man de, Z, Broekhoven-Kruijne, Mj, Schutten, M, Osterhaus, Ad, Boucher, Ca, Driessen, Gj, van Rossum AM, van der Knaap LC, Visser, E, Branger, J, Duijf-van de Ven CJ, Haag, D, Schippers, Ef, van Nieuwkoop, C, Brimicombe, Rw, van IJperen, M, van der Hut, G, Franck, Pf, van Eeden, A, Brokking, W, Groot, M, Damen, M, Kwa, Is, Groeneveld, Ph, Bouwhuis, Jw, van den Berg JF, van Hulzen AG, van der Bliek GL, Bor, Pc, Bloembergen, P, Wolfhagen, Mj, Ruijs, Gj, Gasthuis, K, van Lelyveld SF, Soetekouw, R, Hulshoff, N, van der Prijt LM, Schoemaker, M, Bermon, N, van der Reijden WA, Jansen, R, Herpers, Bl, Veenendaal, D, Kroon, Fp, Arend, Sm, de Boer MG, Bauer, Mp, Jolink, H, Vollaard, Am, Dorama, W, Moons, C, Claas, Ec, Kroes, Ac, den Hollander JG, Pogany, K, Kastelijns, M, Smit, Jv, Smit, E, Bezemer, M, van Niekerk, T, Pontesilli, O, Lowe, Sh, Oude Lashof, A, Posthouwer, D, Ackens, Rp, Schippers, J, Vergoossen, R, Weijenberg Maes, B, Savelkoul, Ph, Loo, Ih, Zuiderzee, Mc, Weijer, S, El Moussaoui, R, Heitmuller, M, Kortmann, W, van Twillert, G, Cohen Stuart JW, Diederen, Bm, Pronk, D, van Truijen-Oud FA, van der Reijden, W, Leyten, Em, Gelinck, Lb, van Hartingsveld, A, Meerkerk, C, Wildenbeest, Gs, Mutsaers, Ja, Jansen, Cl, van Vonderen MG, van Houte DP, Dijkstra, K, Faber, S, Weel, J, Kootstra, Gj, Delsing, Ce, van der Burgvan de Plas, M, Heins, H, Lucas, E, Brinkman, K, Frissen, Ph, Blok, Wl, Schouten, We, Bosma, As, Brouwer, Cj, Geerders, Gf, Hoeksema, K, Kleene, Mj, van der Meché IB, Toonen, Aj, Wijnands, S, van Ogtrop ML, Koopmans, Pp, Keuter, M, van der Ven AJ, ter Hofstede HJ, Dofferhoff, As, van Crevel, R, Albers, M, Bosch, Me, Grintjes-Huisman, Kj, Zomer, Bj, Stelma, Ff, Burger, D, Richter, C, van der Berg JP, Gisolf, Eh, Beest, G, van Bentum PH, Langebeek, N, Tiemessen, R, Swanink, Cm, Veenstra, J, Lettinga, Kd, Spelbrink, M, Sulman, H, Witte, E, Peerbooms, Pg, Mulder, Jw, Vrouenraets, Sm, Lauw, Fn, van Broekhuizen MC, Paap, H, Vlasblom, Dj, Oudmaijer Sanders, E, Smits, Ph, Rosingh, Aw, Verhagen, Dw, Geilings, J, van Kasteren ME, Brouwer, Ae, de Kruijf-van de Wiel BA, Kuipers, M, Santegoets, Rm, van der Ven, B, Marcelis, Jh, Buiting, Ag, Kabel, Pj, Bierman, Wf, Sprenger, Hg, Scholvinck, Eh, van Assen, S, Wilting, Kr, Stienstra, Y, de Groot-de Jonge, H, van der Meulen PA, de Weerd DA, Niesters, Hg, Riezebos-Brilman, A, van Leer-Buter CC, Hoepelman, Ai, Schneider, Mm, Mudrikova, T, Ellerbroek, Pm, Oosterheert, Jj, Arends, Je, Barth, Re, Wassenberg, Mw, van Elst-Laurijssen DH, Laan, Lm, van Oers-Hazelzet EE, Patist, J, Vervoort, S, Nieuwenhuis, He, Frauenfelder, R, Schuurman, R, Verduyn-Lunel, F, Wensing, Am, Peters, Ej, van Agtmael MA, Perenboom, Rm, Bomers, M, de Vocht, J, Elsenburg, Lj, Pettersson, Am, Vandenbroucke-Grauls, Cm, Ang, Cw, Geelen, Sp, Wolfs, Tf, Bont, Lj, Nauta, N, Bezemer, Do, van Sighem AI, Hillebregt, M, Kimmel, V, Tong, Y, Lascaris, B, van den Boogaard, R, Hoekstra, P, de Lang, A, Berkhout, M, Grivell, S, Jansen, A, de Groot, L, van den Akker, M, Bergsma, D, Lodewijk, C, Meijering, R, Peeck, B, Raethke, M, Ree, C, Regtop, R, Ruijs, Y, Schoorl, M, Tuijn, E, Veenenberg, L, Woudstra, T, Bakker, Y, de Jong, A, Broekhoven, M, Claessen, E, Rademaker, Mj, Munjishvili, L, Kruijne, E, Tuk, B, Bouchet, S, Breilh, D, Chêne, G, Dupon, M, Fleury, H, Gaborieau, V, Lacoste, D, Malvy, D, Mercié, P, Neau, D, Pellegrin, I, Pellegrin, Jl, Tchamgoué, S, Fagard, C, Lawson-Ayayi, S, Richert, L, Thiébaut, R, Wittkop, L, André, K, Bernard, N, Caunègre, L, Cazanave, C, Ceccaldi, J, Chossat, I, Courtault, C, Dauchy, Fa, De Witte, S, Dondia, D, Dupont, A, Duffau, P, Dutronc, H, Farbos, S, Faure, I, Gerard, Y, Greib, C, Hessamfar-Joseph, M, Imbert, Y, Lataste, P, Lazaro, E, Marie, J, Mechain, M, Meraud, Jp, Monlun, E, Ochoa, A, Pillot-Debelleix, M, Pistone, T, Raymond, I, Receveur, Mc, Rispal, P, Sorin, L, Valette, C, Vandenhende, Ma, Vareil, Mo, Viallard, Jf, Wille, H, Wirth, G, Moreau, Jf, Lafon, Me, Reigadas, S, Trimoulet, P, Haramburu, F, Miremont-Salamé, G, Blaizeau, Mj, Crespel, I, Decoin, M, Delveaux, S, Diarra, F, D'Ivernois, C, Hanappier, C, Leleux, O, Le Marec, F, Lenaud, E, Mourali, J, Pougetoux, A, Uwamaliya-Nziyumvira, B, Tsaranazy, A, Valdes, A, Conte, V, Louis, I, Palmer, G, Sapparrart, V, Touchard, D, Petoumenos, K, Bendall, C, Moore, R, Edwards, S, Hoy, J, Watson, K, Roth, N, Nicholson, J, Bloch, M, Franic, T, Baker, D, Vale, R, Carr, A, Cooper, D, Chuah, J, Ngieng, M, Nolan, D, Skett, J, Calvo, G, Mateu, S, Domingo, P, Sambeat, Ma, Gatell, J, Del Cacho, E, Cadafalch, J, Fuster, M, Codina, C, Sirera, G, Vaqué, A, De Wit, S, Clumeck, N, Necsoi, C, Gennotte, Af, Gerard, M, Kabeya, K, Konopnicki, D, Libois, A, Martin, C, Payen, Mc, Semaille, P, Van, Y, Neaton, J, Bartsch, G, El-Sadr, Wm, Krum, E, Thompson, G, Wentworth, D, Luskin-Hawk, R, Telzak, E, Abrams, Di, Cohn, D, Markowitz, N, Arduino, R, Mushatt, D, Friedland, G, Perez, G, Tedaldi, E, Fisher, E, Gordin, F, Crane, Lr, Sampson, J, Baxter, J, Losso, M, Kundro, M, Vetter, N, Zangerle, R, Karpov, I, Vassilenko, A, Mitsura, Vm, Paduto, D, Florence, E, Vandekerckhove, L, Hadziosmanovic, V, Kostov, K, Begovac, J, Machala, L, Jilich, D, Sedlacek, D, Kronborg, G, Benfield, T, Gerstoft, J, Katzenstein, T, Hansen, Ab, Pedersen, C, Møller, Nf, Ostergaard, L, Dragsted, Ub, Nielsen, Ln, Zilmer, K, Smidt, J, Ristola, M, Aho, I, Katlama, C, Viard, Jp, Girard, Pm, Cotte, L, Duvivier, C, Rockstroh, J, Schmidt, R, van Lunzen, J, Degen, O, Stellbrink, Hj, Stefan, C, Bogner, J, Chkhartishvili, N, Kosmidis, J, Gargalianos, P, Xylomenos, G, Lourida, P, Sambatakou, H, Banhegyi, D, Gottfredsson, M, Mulcahy, F, Yust, I, Turner, D, Burke, M, Shahar, E, Hassoun, G, Elinav, H, Haouzi, M, Sthoeger, Zm, D'Arminio Monforte, A, Esposito, R, Mazeu, I, Mussini, C, Mazzotta, F, Gabbuti, A, Vullo, V, Lichtner, M, Zaccarelli, M, Antinori, A, Acinapura, R, D'Offizi, G, Lazzarin, A, Castagna, A, Gianotti, N, Galli, M, Ridolfo, A, Rozentale, B, Uzdaviniene, V, Matulionyte, R, Staub, T, Hemmer, R, Ormaasen, V, Maeland, A, Bruun, J, Knysz, B, Gasiorowski, J, Inglot, M, Horban, A, Bakowska, E, Grzeszczuk, A, Flisiak, R, Parczewski, M, Pynka, M, Maciejewska, K, Beniowski, M, Mularska, E, Smiatacz, T, Gensing, M, Jablonowska, E, Malolepsza, E, Wojcik, K, Mozer-Lisewska, I, Doroana, M, Caldeira, L, Mansinho, K, Maltez, F, Radoi, R, Oprea, C, Rakhmanova, A, Trofimora, T, Khromova, I, Kuzovatova, E, Jevtovic, D, Shunnar, A, Staneková, D, Tomazic, J, Moreno, S, Rodriguez, J, Clotet, B, Jou, A, Paredes, R, Tural, C, Puig, J, Bravo, I, Gatell, Jm, Miró, Jm, Gutierrez, M, Mateo, G, Laporte, Jm, Blaxhult, A, Flamholc, L, Falconer, K, Thalme, A, Sonnerborg, A, Ledergerber, B, Cavassini, M, Calmy, A, Furrer, H, Battegay, M, Elzi, L, Schmid, P, Kravchenko, E, Chentsova, N, Frolov, V, Kutsyna, G, Baskakov, I, Servitskiy, S, Kuznetsova, A, Kyselyova, G, Gazzard, B, Johnson, Am, Simons, E, Johnson, Ma, Orkin, C, Weber, J, Scullard, G, Fisher, M, Leen, C, Lundgren, J, Grarup, J, Cozzi-Lepri, A, Thiebaut, R, Peters, L, Fischer, Ah, Grønborg Laut, K, Larsen, Jf, Podlekareva, D, Grint, D, Shepherd, L, Schultze, A, Morfeldt, L, Thulin, G, Åkerlund, B, Koppel, K, Karlsson, A, Håkangård, C, Moroni, M, Angarano, G, Armignacco, O, Castelli, F, Cauda, R, Di Perri, G, Iardino, R, Ippolito, G, Perno, Cf, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Andreoni, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, R, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gori, A, Guaraldi, G, Lapadula, G, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantini, A, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, Pe, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Cassola, G, Viscoli, G, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Castelli, A, Rizzardini, G, Ridolfo, Al, Piolini, R, Salpietro, S, Carenzi, L, Moioli, Mc, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, Mg, Onofrio, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, Ma, D'Avino, A, Gallo, L, Nicastri, E, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Mura, Ms, Caramello, P, Orofino, Gc, Sciandra, M, Pellizzer, G, Manfrin, V, Castelli, Ap, Dollet, K, Caissotti, C, Dellamonica, P, Bernard, E, Cua, E, De Salvador-Guillouet, F, Durant, J, Ferrando, S, Dunais, B, Mondain-Miton, V, Naqvi, A, Perbost, I, Prouvost-Keller, B, Pillet, S, Pugliese, P, Risso, K, Roger, Pm, Aubert, V, Bernasconi, E, Böni, J, Bucher, Hc, Burton-Jeangros, C, Dollenmaier, G, Egger, M, Fehr, J, Fellay, J, Gorgievski, M, Günthard, H, Haerry, D, Hasse, B, Hirsch, Hh, Hoffmann, M, Hösli, I, Kahlert, C, Kaiser, L, Keiser, O, Klimkait, T, Kouyos, R, Kovari, H, Martinetti, G, Martinez de Tejada, B, Metzner, K, Müller, N, Nadal, D, Nicca, D, Pantaleo, G, Rauch, A, Regenass, S, Rudin, C, Schöni-Affolter, F, Schüpbach, J, Speck, R, Tarr, P, Telenti, A, Trkola, A, Vernazza, P, Yerly, S., University College of London [London] (UCL), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Chemical Biology, Internal Medicine, Medical Microbiology & Infectious Diseases, Pediatrics, Virology, Mocroft, A:, Lundgren, Jd, Ross, M, Fux, Ca, Reiss, P, Moranne, O, Morlat., P, Monforte, Ad, Kirk, O, Ryom, L, for the Data Collection on Adverse events of Anti-HIV Drugs (D:A:D), Study, Lazzarin, A, Castagna, A, Other departments, AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Global Health, Infectious diseases, Paediatric Infectious Diseases / Rheumatology / Immunology, General Internal Medicine, Center of Experimental and Molecular Medicine, Graduate School, Medical Microbiology and Infection Prevention, Gastroenterology and Hepatology, APH - Health Behaviors & Chronic Diseases, Med Microbiol, Infect Dis & Infect Prev, MUMC+: DA MMI Staf (9), MUMC+: MA Alg Interne Geneeskunde (9), MUMC+: DA MMI Infectieserologie (9), MUMC+: DA MMI AIOS (9), RS: FHML non-thematic output, Mocroft, A, Lundgren, J, Fux, C, Morlat, P, Monforte, A, and Gori, A
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0301 basic medicine ,Male ,PROTEASE INHIBITOR ,Epidemiology ,Infectious Diseases ,Immunology ,Virology ,Research Support, U.S. Gov't, P.H.S ,HIV Infections ,SDG 3 – Goede gezondheid en welzijn ,Rate ratio ,THERAPY ,chemistry.chemical_compound ,0302 clinical medicine ,HIV ,antiretroviral ,kidney disease ,immune system diseases ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Medicine and Health Sciences ,HIV Infection ,030212 general & internal medicine ,Prospective Studies ,Renal Insufficiency ,Chronic ,Prospective cohort study ,Research Support, Non-U.S. Gov't ,Antiretrovirals ,virus diseases ,Lopinavir ,ASSOCIATION ,Middle Aged ,3. Good health ,Europe ,Antiretrovirals, HIV, chronic kidney disease ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Female ,NAIVE PATIENTS ,CREATININE ,Human ,Cohort study ,medicine.drug ,Glomerular Filtration Rate ,United State ,Adult ,medicine.medical_specialty ,TENOFOVIR DISOPROXIL FUMARATE ,RENAL-FUNCTION ,Adolescent ,Anti-HIV Agents ,Atazanavir Sulfate ,Renal function ,Infectious Disease ,Australia ,Humans ,Renal Insufficiency, Chronic ,Tenofovir ,United States ,Young Adult ,NO ,03 medical and health sciences ,EFAVIRENZ ,SDG 3 - Good Health and Well-being ,Internal medicine ,Journal Article ,medicine ,Creatinine ,business.industry ,Anti-HIV Agent ,medicine.disease ,030112 virology ,Atazanavir ,INFECTED INDIVIDUALS ,Prospective Studie ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,chemistry ,RISK-FACTORS ,business ,chronic kidney disease ,Kidney disease - Abstract
BACKGROUND: Whether or not the association between some antiretrovirals used in HIV infection and chronic kidney disease is cumulative is a controversial topic, especially in patients with initially normal renal function. In this study, we aimed to investigate the association between duration of exposure to antiretrovirals and the development of chronic kidney disease in people with initially normal renal function, as measured by estimated glomerular filtration rate (eGFR).METHODS: In this prospective international cohort study, HIV-positive adult participants (aged ≥16 years) from the D:A:D study (based in Europe, the USA, and Australia) with first eGFR greater than 90 mL/min per 1·73 m(2) were followed from baseline (first eGFR measurement after Jan 1, 2004) until the occurrence of one of the following: chronic kidney disease; last eGFR measurement; Feb 1, 2014; or final visit plus 6 months (whichever occurred first). Chronic kidney disease was defined as confirmed (>3 months apart) eGFR lower than 60 mL/min per 1·73 m(2). The primary outcome was the occurrence of chronic kidney disease. Poisson regression was used to estimate the incidence rate of chronic kidney disease associated with cumulative exposure to tenofovir disoproxil fumarate, ritonavir-boosted atazanavir, ritonavir-boosted lopinavir, other ritonavir-boosted protease inhibitors, or abacavir.FINDINGS: Between Jan 1, 2004, and July 26, 2013, 23,905 eligible individuals from the D:A:D study were included. Participants had a median baseline eGFR of 110 mL/min per 1·73 m(2) (IQR 100-125), a median age of 39 years (33-45), and median CD4 cell count of 441 cells per mm(3) (294-628). During a median follow-up of 7·2 years (IQR 5·1-8·9), 285 (1%) of 23,905 people developed chronic kidney disease (incidence 1·76 per 1000 person-years of follow-up [95% CI 1·56-1·97]). After adjustment, we recorded a significant increase in chronic kidney disease associated with each additional year of exposure to tenofovir disoproxil fumarate (adjusted incidence rate ratio 1·14 [95% CI 1·10-1·19], pINTERPRETATION: In people with normal renal function, the annual incidence of chronic kidney disease increased for up to 6 years of exposure to tenofovir disoproxil fumarate, ritonavir-boosted atazanavir, or ritonavir-boosted lopinavir therapy. Although the absolute number of new cases of chronic kidney disease was modest, treatment with these antiretrovirals might result in an increasing and cumulative risk of chronic kidney disease. Patients on potentially nephrotoxic antiretrovirals or at high risk of chronic kidney disease should be closely monitored.FUNDING: The Highly Active Antiretroviral Therapy Oversight Committee.
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- 2016
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48. Non-AIDS defining cancers in the D:A:D Study--time trends and predictors of survival: a cohort study
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Worm, S, Bower, M, Reiss, P, Bonnet, F, Law, M, Fätkenheuer, G, d'Arminio Monforte, A, Abrams, D, Grulich, A, Fontas, E, Kirk, O, Furrer, H, Wit, S, Phillips, A, Lundgren, J, Sabin, C, Butcher, D, Delforge, M, Fanti, I, Franquet, X, Geffard, S, Gras, L, Helweg Larsen, J, Hillebregt, M, Kamara, D, Kjær, J, Krum, E, McManus, H, Meidahl, P, Mocroft, A, Nielsen, J, Powderl, W, Rickenbach, M, Rode, R, Ryom, L, Salbøl Brandt, R, Schmidt Iversen, J, Shortman, N, Sjøl, A, Smith, C, Torres, F, Tverland, J, Wright, S, Zaheri, S, de Wolf, F, Smidt, J, Ristola, M, Katlama, C, Viard, J, Girard, P, Livrozet, J, Vanhems, P, Pradier, C, Dabis, F, Neau, D, Rockstroh, J, Schmidt, R, Degen, O, van Lunzen, J, Stellbrink, H, Staszewski, S, Bogner, J, Gargalianos, P, Kosmidis, J, Perdios, J, Xylomenos, G, Filandras, A, Karabatsaki, E, Panos, G, Sambatakou, H, Banhegyi, D, Mulcahy, F, Burke, M, Turner, D, Yust, I, Hassoun, G, Pollack, S, Maayan, S, Vella, S, Esposito, R, Mazeu, I, Mussini, C, Arici, C, 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Structures et propriétés d'architectures moléculaire (SPRAM - UMR 5819), Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Institut Nanosciences et Cryogénie (INAC), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Observatoire des Micro et Nano Technologies (OMNT - UMS 2920), Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS), Université Paris 1 Panthéon-Sorbonne - UFR d'Économie (UP1 UFR02), Université Paris 1 Panthéon-Sorbonne (UP1), Laboratory, Royal GD [Deventer], Economics, Umeå University, Research Department of Infection and Population Health [London], University College of London [London] (UCL), Clinicum, Department of Medicine, Infektiosairauksien yksikkö, Worm, S, Bower, M, Reiss, P, Bonnet, F, Law, M, Fätkenheuer, G, d'Arminio Monforte, A, Abrams, D, Grulich, A, Fontas, E, Kirk, O, Furrer, H, Wit, S, Phillips, A, Lundgren, J, Sabin, C, Butcher, D, Delforge, M, Fanti, I, Franquet, X, Geffard, S, Gras, L, Helweg Larsen, J, Hillebregt, M, Kamara, D, Kjær, J, Krum, E, Mcmanus, H, Meidahl, P, Mocroft, A, Nielsen, J, Powderl, W, Rickenbach, M, Rode, R, Ryom, L, Salbøl Brandt, R, Schmidt Iversen, J, Shortman, N, Sjøl, A, Smith, C, Torres, F, Tverland, J, Wright, S, Zaheri, S, de Wolf, F, Smidt, J, Ristola, M, Katlama, C, Viard, J, Girard, P, Livrozet, J, Vanhems, P, Pradier, C, Dabis, F, Neau, D, Rockstroh, J, Schmidt, R, Degen, O, van Lunzen, J, Stellbrink, H, Staszewski, S, Bogner, J, Gargalianos, P, Kosmidis, J, Perdios, J, Xylomenos, G, Filandras, A, Karabatsaki, E, Panos, G, Sambatakou, H, Banhegyi, D, Mulcahy, F, Burke, M, Turner, D, Yust, I, Hassoun, G, Pollack, S, Maayan, S, Vella, S, Esposito, R, Mazeu, I, Mussini, C, Arici, C, Pristera, R, Gabbuti, A, Mazzotta, F, Lichtner, M, Vullo, V, Boer, K, Geerlings, S, Godfried, M, Kuijpers, T, Lange, J, Nellen, F, Pajkrt, D, Prins, J, Scherpbier, H, Vrouenraets, S, Wit, F, van Vugt, M, van der Meer, J, van der Poll, T, van der Valk, M, Chirianni, A, Gargiulo, M, Montesarchio, E, Antonucci, G, Narciso, P, Testa, A, Vlassi, C, Zaccarelli, M, Castagna, A, Gianotti, N, Lazzarin, A, Galli, M, Ridolfo, A, Rozentale, B, Zeltina, I, Chaplinskas, S, Hemmer, R, Staub, T, Bruun, J, Maeland, A, Ormaasen, V, Lowe, S, Oude Lashof, A, Schreij, G, Gasiorowski, J, Knysz, B, Bakowska, E, Horban, A, Flisiak, R, Grzeszczuk, A, Boron Kaczmarska, A, Parczewski, M, Pynka, M, Beniowski, M, Mularska, E, Trocha, H, Jablonowska, E, Malolepsza, E, Wojcik, K, Antunes, F, Caldeira, L, Doroana, M, Mansinho, K, Maltez, F, Bravenboer, B, Pronk, M, Duiculescu, D, Rakhmanova, A, Zakharova, N, Buzunova, S, Jevtovic, D, Mokráš, M, Staneková, D, Tomazic, J, González Lahoz, J, Labarga, P, Medrano, J, Soriano, V, Moreno, S, Rodriguez, J, Bravo, I, Clotet, B, Jou, A, Paredes, R, Puig, J, Tural, C, Gelinck, L, Nouwen, J, Rijnders, B, Schurink, C, Slobbe, L, Verbon, A, de Vries Sluijs, T, van der Ende, M, van der Feltz, M, Gatell, J, Miró, J, Domingo, P, Gutierrez, M, Mateo, G, Sambeat, M, Karlsson, A, Flamholc, L, Ledergerber, B, Weber, R, Cavassini, M, Francioli, P, Boffi, E, Hirschel, B, Battegay, M, Elzi, L, Chentsova, N, Kravchenko, E, Driessen, G, Hartwig, N, Frolov, V, Kutsyna, G, Servitskiy, S, Krasnov, M, Barton, S, Johnson, A, Mercey, D, Johnson, M, Murphy, M, Scullard, G, Weber, J, Fisher, M, Leen, C, Branger, J, Åkerlund, B, Morfeldt, L, S. u. n. d. s. t. r. ö. m., A, Thulin, G, Koppel, K, Ho̊kangård, C, Angarano, G, Antinori, A, Armignacco, O, Castelli, F, Cauda, R, Di Perri, G, Iardino, R, Ippolito, G, Moroni, M, Perno, C, Viale, P, Von Schlosser, F, Ammassari, A, Andreoni, M, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Ceccherini Silberstein, F, Cinque, P, Cozzi Lepri, A, De Luca, A, Gervasoni, C, Girardi, E, Gori, A, Guaraldi, G, Lo Caputo, S, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Murri, R, Puoti, M, Torti, C, Cicconi, P, Formenti, T, Galli, L, Lorenzini, P, Costantini, A, Giacometti, A, Riva, A, Carrisa, C, Lazzari, G, Verucchi, G, Kauffmann, R, Schippers, E, Minardi, C, Abeli, C, Quirino, T, Manconi, P, Piano, P, Falasca, K, Vecchiet, J, Segala, D, Sighinolfi, L, Alessandrini, A, Cassola, G, Mazzarello, G, Piscopo, R, Viscoli, G, Belvisi, V, Mastroianni, C, Caramma, I, Castelli, P, Chiodera, A, Alleman, M, Bouwhuis, J, Groeneveld, P, Bigoloni, A, Carenzi, L, Galli, A, Moioli, M, Piolini, R, Rizzardini, G, Rossotti, R, Salpietro, S, Spagnuolo, V, Zucchi, P, Bisio, L, Lapadula, G, Abrescia, N, Guida, M, Baldelli, F, Belfiori, B, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Acinapura, R, Capozzi, M, Gallo, L, Libertone, R, Nicastro, E, Tebano, G, Tozzi, V, D'Avino, A, Mura, M, Caramello, P, Orofino, G, Sciandra, M, Soetekouw, R, ten Kate, R, Manfrin, V, Pellizzer, G, Bernard, E, Caissotti, C, Cua, E, De Salvador Guillouet, F, Dellamonica, P, Dollet, K, Durant, J, Ferrando, S, Mondain Miton, V, Naqvi, A, Perbost, I, Pillet, S, Prouvost Keller, B, Pugliese, P, Rahelinirina, V, Roger, P, Barth, J, Bernasconi, E, Böni, J, Bucher, H, Burton Jeangros, C, Calmy, A, Cellerai, C, Dubs, R, Egger, M, Fehr, J, Flepp, M, Fux, C, Gorgievski, M, Günthard, H, Hasse, B, Hirsch, H, Hösli, I, Kahlert, C, Kaiser, L, Keiser, O, Kind, C, Klimkait, T, Kovari, H, Martinetti, G, Martinez de Tejada, B, Müller, N, Nadal, D, Pantaleo, G, Rauch, A, Regenass, S, Rudin, C, Schmid, P, Schöni Affolter, F, Schüpbach, J, Schultze, D, Speck, R, Taffé, P, Telenti, A, Trkola, A, Vernazza, P, Yerly, S, von Wyl, V, Arend, S, Jolink, H, Kroon, F, de Boer, M, van Dissel, J, van Nieuwkoop, C, van den Broek, P, Pogany, K, den Hollander, J, Kortmann, W, van Twillert, G, Leyten, E, Vriesendorp, R, Kootstra, G, ten Napel, C, Blok, W, Brinkman, K, Frissen, P, Schouten, W, van den Berk, G, Brouwer, A, Juttmann, J, van Kasteren, M, Lettinga, K, Veenstra, J, Mulder, J, Smit, P, Weijer, S, van Gorp, E, Verhagen, D, van Eeden, A, Doedens, R, Scholvinck, E, Sprenger, H, Stek, C, van Assen, S, Dofferhoff, A, Keuter, M, Koopmans, P, de Groot, R, ter Hofstede, H, van der Flier, M, van der Ven, A, Arends, J, Ellerbroek, P, Hoepelman, A, Jaspers, C, Maarschalk Ellerbroek, L, Mudrikova, T, Oosterheert, J, Peters, E, Schneider, M, Wassenberg, M, van der Hilst, J, Bierman, W, Claessen, F, Danner, S, Perenboom, R, bij de Vaate, E, de Jong, E, de Vocht, J, van Agtmael, M, Geelen, S, Wolfs, T, Gisolf, E, Richter, J, van der Berg, C, Stegeman, A, van den Berge, M, Polée, M, van Houte, D, van Vonderen, M, Duits, A, Winkel, C, Chêne, G, Dupon, M, Fleury, H, Lacoste, D, Malvy, D, Mercié, P, Morlat, P, Pellegrin, I, Pellegrin, J, Thiébaut, R, Titier, K, Bruyand, M, Lawson Ayayi, S, Wittkop, L, Bernard, N, Bonnal, F, Caunègre, L, Cazanave, C, Ceccaldi, J, Chambon, D, Chossat, I, Courtaud, K, Dauchy, F, De Witte, S, Duffau, P, Dupont, A, Dutronc, H, Farbos, S, Gaboriau, V, Gemain, M, Gerard, Y, Greib, C, Hessamfar, M, Lafarie Castet, S, Lataste, P, Lazaro, E, Longy Boursier, M, Meraud, J, Monlun, E, Ochoa, A, Pistone, T, Ragnaud, J, Receveur, M, Roger Schmeltz, J, Tchamgoué, S, Thibaut, P, Vandenhende, M, Viallard, J, Moreau, J, P. e. l. l. e. g. r. i. n., I, Lafon, M, Masquelier, B, Trimoulet, P, Breilh, D, Haramburu, F, Miremont Salamé, G, Blaizeau, M, D'Ivernois, C, Decoin, M, Delaune, J, Delveaux, S, Hanappier, C, Leleux, O, Sicard, X, Uwamaliya Nziyumvira, B, Leray, J, Palmer, G, Touchard, D, Baker, D, Bendall, C, Bloch, M, Carr, A, Cooper, D, Franic, T, Petoumenos, K, Vale, R, Edwards, S, Hoy, J, Moore, R, Nicholson, J, Roth, N, Watson, K, Chuah, J, Ngieng, M, Nolan, D, Skett, J, Cadafalch, J, Calvo, G, Codina, C, Del Cacho, E, Fuster, M, Mateu, S, Sirera, G, Vaqué, A, Clumeck, N, De Wit, S, Gennotte, A, Gerard, M, Kabeya, K, Konopnicki, D, Libois, A, Martin, C, Necsoi, C, Payen, M, Semaille, P, Van Laethem, Y, Bartsch, G, El Sadr, W, Neaton, J, Thompson, G, Wentworth, D, Luskin Hawk, R, Telzak, E, Cohn, D, Markowitz, N, Arduino, R, Mushatt, D, Friedland, G, Perez, G, Tedaldi, E, Fisher, E, Gordin, F, Crane, L, Sampson, J, Baxter, J, Fischer, A, Grint, D, Kjaer, J, Kowalska, J, Peters, L, Podlekareva, D, Reekie, J, Elias, C, Losso, M, Vetter, N, Zangerle, R, Karpov, I, Vassilenko, A, Mitsura, V, Suetnov, O, Colebunders, R, Vandekerckhove, L, Hadziosmanovic, V, Kostov, K, Begovac, J, Jilich, D, Machala, L, Sedlacek, D, Benfield, T, Kronborg, G, Larsen, M, Gerstoft, J, Hansen, A, Katzenstein, T, Skinhøj, P, Pedersen, C, Ostergaard, L, Zilmer, K, Internal medicine, Pediatric surgery, Plastic, Reconstructive and Hand Surgery, CCA - Innovative therapy, IOO, Worm, Signe W., Bower, Mark, Reiss, Peter, Bonnet, Fabrice, Law, Matthew, Fã¤tkenheuer, Gerd, D'arminio Monforte, Antonella, Abrams, Donald I., Grulich, Andrew, Fontas, Eric, Kirk, Ole, Furrer, Hansjakob, Wit, Stephane D., Phillips, Andrew, Lundgren, Jens D., Sabin, Caroline A., D:A:D Study, Group, Experimental Psychology, Groningen Research Institute for Asthma and COPD (GRIAC), Amsterdam institute for Infection and Immunity, Amsterdam Public Health, Global Health, Other departments, Infectious diseases, Paediatric Infectious Diseases / Rheumatology / Immunology, Other Research, Obstetrics and Gynaecology, General Internal Medicine, Center of Experimental and Molecular Medicine, Medical Microbiology and Infection Prevention, Institut Nanosciences et Cryogénie (INAC), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)
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Male ,Kaplan Meier method ,proportional hazards model ,SWISS HIV COHORT ,HIV Infections ,0302 clinical medicine ,1108 Medical Microbiology ,cancer diagnosis ,Prospective Studies ,Pathologie maladies infectieuses ,cancer survival ,ComputingMilieux_MISCELLANEOUS ,IMMUNODEFICIENCY ,Incidence ,Sciences bio-médicales et agricoles ,cohort analysis ,Prognosis ,3. Good health ,[SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology ,D:A:D Study Group ,risk factor ,030220 oncology & carcinogenesis ,Cohort ,Cohort study ,prospective study ,Human ,medicine.medical_specialty ,Prognosi ,HIV ,Non-AIDS defining cancers ,Trends ,Adult ,Anti-HIV Agents ,Antiretroviral Therapy, Highly Active ,CD4 Lymphocyte Count ,Female ,Humans ,Kaplan-Meier Estimate ,Middle Aged ,Neoplasms ,Infectious Diseases ,non AIDS defining cancer ,Microbiology ,cancer prognosis ,03 medical and health sciences ,death ,Anal cancer ,Risk factor ,Proportional hazards model ,HIV Infections -- drug therapy -- mortality ,Anti-HIV Agent ,Anti-HIV Agents/therapeutic use ,Antiretroviral Therapy ,HIV Infections/drug therapy/ mortality ,medicine.disease ,major clinical study ,mortality ,Prospective Studie ,age ,Neoplasms -- mortality ,observational study ,cancer incidence ,anus cancer ,gender ,Trend ,Medicine and Health Sciences ,HIV Infection ,030212 general & internal medicine ,Prospective cohort study ,survival prediction ,RISK ,INFECTED PATIENTS ,ACTIVE ANTIRETROVIRAL THERAPY ,Incidence (epidemiology) ,article ,Human immunodeficiency virus infected patient ,ANAL CANCER ,Non-AIDS defining cancer ,Anti-HIV Agents -- therapeutic use ,ethnicity ,0605 Microbiology ,Research Article ,Hodgkin disease ,UNITED-STATES ,610 Medicine & health ,smoking ,NO ,MALIGNANCIES ,Internal medicine ,mental disorders ,medicine ,follow up ,Highly Active ,controlled study ,Lung cancer ,HODGKINS-DISEASE ,disseminated cancer ,business.industry ,1103 Clinical Sciences ,BONE-MARROW-TRANSPLANTATION ,Surgery ,lung cancer ,3121 General medicine, internal medicine and other clinical medicine ,Neoplasm ,business - Abstract
Non-AIDS defining cancers (NADC) are an important cause of morbidity and mortality in HIV-positive individuals. Using data from a large international cohort of HIV-positive individuals, we described the incidence of NADC from 2004-2010, and described subsequent mortality and predictors of these., SCOPUS: ar.j, info:eu-repo/semantics/published
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- 2013
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49. Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update 2011
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Antinori, A, Marcotullio, S, Ammassari, A, Andreoni, M, Angarano, G, Armignacco, O, Carosi, G, Cinque, P, d'Arminio Monforte, A, Di Perri, G, Ensoli, B, Floridia, M, Galli, M, Mastroianni, C, Matteelli, A, Mazzotta, F, Moroni, M, Pal, G, Puoti, M, Puro, V, Rizzardini, G, Sagnelli, E, Vella, S, Vullo, V, Lazzarin, A, Italian HIV Guidelines Working Group, Baldelli, Franco, Antinori, A, Marcotullio, S, Ammassari, A, Andreoni, M, Angarano, G, Armignacco, O, Carosi, G, Cinque, P, d'Arminio Monforte, A, Di Perri, G, Ensoli, B, Floridia, M, Galli, M, Mastroianni, C, Matteelli, A, Mazzotta, F, Moroni, M, Pal, G, Puoti, M, Puro, V, Rizzardini, G, Sagnelli, E, Vella, S, Vullo, V, Lazzarin, A, and Gori, A
- Subjects
Anti-HIV Agents ,MATERNAL-INFANT TRANSMISSION ,RAPID SCREENING-TEST ,hiv ,HIV Infections ,HIV-INFECTED PATIENTS ,INTIMA-MEDIA THICKNESS ,RANDOMIZED COMPARATIVE TRIAL ,QUALITY-OF-LIFE ,Humans ,HIV Infection ,infected persons ,antiretrovirals ,REVERSE-TRANSCRIPTASE INHIBITORS ,SOCIETY EACS GUIDELINES ,CENTRAL-NERVOUS-SYSTEM ,Anti-HIV Agent ,PNEUMOCYSTIS-CARINII-PNEUMONIA ,IMMUNODEFICIENCY-VIRUS TYPE-1 ,Settore MED/07 - Microbiologia e Microbiologia Clinica ,Italy ,HIV-1 ,NON-HODGKIN-LYMPHOMA ,Human - Abstract
Authorized by the Ministry of Health and Istituto Superiore di Sanità, National AIDS Centre. In collaboration with the National AIDS Commission and the Conference of Associations for the War Against AIDS, Ministry of Health, and with the Italian Society of Infectious and Tropical Diseases (SIMIT).
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- 2012
50. Development and validation of a risk score for chronic kidney disease in HIV infection using prospective cohort data from the D:A:D study
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Mocroft, Amanda, Lundgren, Jens D., Ross, Michael, Law, Matthew, Reiss, Peter, Kirk, Ole, Smith, Colette, Wentworth, Deborah, Neuhaus, Jacqueline, Fux, Christoph A., Moranne, Olivier, Morlat, Phillipe, Johnson, Margaret A., Ryom, Lene, Lundgren, J. D., Powderly, B., Shortman, N., Moecklinghoff, C., Reilly, G., Franquet, X., Sabin, C. A., Phillips, A., Kirk, O., Reiss, P., Weber, R., Pradier, C., Law, M., d'Arminio Monforte, A., Dabis, F., El-Sadr, W. M., De Wit, S., Ryom, L., Kamara, D., Smith, C., Mocroft, A., Tverland, J., Mansfeld, M., Nielsen, J., Raben, D., Salbøl Brandt, R., Rickenbach, M., Fanti, I., Krum, E., Hillebregt, M., Geffard, S., Sundström, A., Delforge, M., Fontas, E., Torres, F., Mcmanus, H., Wright, S., Kjær, J., Sjøl, A., Meidahl, P., Helweg-Larsen, J., Schmidt Iversen, J., Ross, M., Fux, C. A., Morlat, P., Moranne, O., Kesselring, A. M., Kamara, D. A., Friis-Møller, N., Kowalska, J., Sabin, C., Bruyand, M., Bower, M., Fätkenheuer, G., Donald, A., Grulich, A., Prins, J. M., Kuijpers, T. W., Scherpbier, H. J., van der Meer, J. T. M., Wit, F. W. M. N., Godfried, M. H., van der Poll, T., Nellen, F. J. B., Geerlings, S. E., van Vugt, M., Pajkrt, D., Bos, J. C., Wiersinga, W. J., van der Valk, M., Goorhuis, A., Hovius, J. W., van Eden, J., Henderiks, A., van Hes, A. M. H., Mutschelknauss, M., Nobel, H. E., Pijnappel, F. J. J., Westerman, A. M., Jurriaans, S., Back, N. K. T., Zaaijer, H. L., Berkhout, B., Cornelissen, M. T. E., Schinkel, C. J., Thomas, X. V., van den Berge, M., Stegeman, A., Baas, S., Hage de Looff, L., Versteeg, D., Pronk, M. J. H., Ammerlaan, H. S. M., Korsten-Vorstermans, E. M. H. M., de Munnik, E. S., Jansz, A. R., Tjhie, J., Wegdam, M. C. A., Deiman, B., Scharnhorst, V., van der Plas, A., Weijsenfeld, A. M., van der Ende, M. E., de Vries-Sluijs, T. E. M. S., C. M. van Gorp, E., Schurink, C. A. M., Nouwen, J. L., Verbon, A., Rijnders, B. J. A., Bax, H. I., Hassing, R. J., van der Feltz, M., Bassant, N., van Beek, J. E. A., Vriesde, M., van Zonneveld, L. M., de Oude-Lubbers, A., van den Berg-Cameron, H. J., Bruinsma-Broekman, F. B., de Groot, J., de Zeeuw- de Man, M., Broekhoven-Kruijne, M. J., Schutten, M., Osterhaus, A. D. M. E., Boucher, C. A. B., Driessen, G. J. A., van Rossum, A. M. C., van der Knaap, L. C., Visser, E., Branger, J., H. M. Duijf-van de Ven, C. J., Schippers, E. F., van Nieuwkoop, C., Brimicombe, R. W., van IJperen, J. M., van der Hut, G., Franck, P. F. H., van Eeden, A., Brokking, W., Groot, M., Damen, M., Kwa, I. S., Groeneveld, P. H. P., Bouwhuis, J. W., van den Berg, J. F., van Hulzen, A. G. W., van der Bliek, G. L., Bor, P. C. J., Bloembergen, P., Wolfhagen, M. J. H. M., Ruijs, G. J. H. M., van Lelyveld, S. F. L., Soetekouw, R., Hulshoff, N., van der Prijt, L. M. M., Schoemaker, M., Bermon, N., van der Reijden, W. A., Jansen, R., Herpers, B. L., Veenendaal, D., Kroon, F. P., Arend, S. M., de Boer, M. G. J., Bauer, M. P., Jolink, H., Vollaard, A. M., Dorama, W., Moons, C., Claas, E. C. J., Kroes, A. C. M., den Hollander, J. G., Pogany, K., Kastelijns, M., Smit, J. V., Smit, E., Bezemer, M., van Niekerk, T., Pontesilli, O., Lowe, S. H., Oude Lashof, A., Posthouwer, D., Ackens, R. P., Schippers, J., Vergoossen, R., Weijenberg Maes, B., Savelkoul, P. H. M., Loo, I. H., Weijer, S., El Moussaoui, R., Heitmuller, M., Kortmann, W., van Twillert, G., Cohen Stuart, J. W. T., Diederen, B. M. W., Pronk, D., van Truijen-Oud, F. A., Leyten, E. M. S., Gelinck, L. B. S., van Hartingsveld, A., Meerkerk, C., Wildenbeest, G. S., Mutsaers, J. A. E. M., Jansen, C. L., van Vonderen, M. G. A., van Houte, D. P. F., Dijkstra, K., Faber, S., Weel, J., Kootstra, G. J., Delsing, C. E., van der Burg-van de Plas, M., Heins, H., Lucas, E., Brinkman, K., Frissen, P. H. J., Blok, W. L., Schouten, W. E. M., Bosma, A. S., Brouwer, C. J., Geerders, G. F., Hoeksema, K., Kleene, M. J., van der Meché, I. B., Toonen, A. J. M., Wijnands, S., van Ogtrop, M. L., Koopmans, P. P., Keuter, M., van der Ven, A. J. A. M., ter Hofstede, H. J. M., Dofferhoff, A. S. M., van Crevel, R., Albers, M., Bosch, M. E. W., Grintjes-Huisman, K. J. T., Zomer, B. J., Stelma, F. F., Burger, D., Richter, C., van der Berg, J. P., Gisolf, E. H., ter Beest, G., van Bentum, P. H. M., Langebeek, N., Tiemessen, R., Swanink, C. M. A., Veenstra, J., Lettinga, K. D., Spelbrink, M., Sulman, H., Witte, E., Peerbooms, P. G. H., Mulder, J. W., Vrouenraets, S. M. E., Lauw, F. N., van Broekhuizen, M. C., Paap, H., Vlasblom, D. J., Oudmaijer Sanders, E., Smits, P. H. M., Rosingh, A. W., Verhagen, D. W. M., Geilings, J., van Kasteren, M. E. E., Brouwer, A. E., de Kruijf-van de Wiel, B. A. F. M., Kuipers, M., Santegoets, R. M. W. J., van der Ven, B., Marcelis, J. H., G. M. Buiting, A., Kabel, P. J., Bierman, W. F. W., Sprenger, H. G., Scholvinck, E. 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L., Panchalingam, A., Quek, A., Alcázar-Caballero, R., Arribas, J., Arrizabalaga, J., de Barron, X., Blanco, F., Bouza, E., Calvo, S., Carbonero, L., Carpena, I., Castro, M., Cortes, L., del Toro, M., Elias, M., Espinosa, J., Estrada, V., Fernandez-Cruz, E., Fernández, P., Freud, H., Garcia, A., Garcia, G., Garrido, R., Gijón, P., Gonzalez- García, J., Gil, I., González, A., López Grosso, P., Guzmán, E., Iribarren, J., Jiménez, M., Juega, J., Lopez, J., Lozano, F., Martín-Carbonero, L., Mata, R., Menasalvas, A., Mirelles, C., de Miguel Prieto, J., Montes, M., Moreno, A., Moreno, J., Moreno, V., Muñoz, R., Ocampo, A., Ortega, E., Ortiz, L., Padilla, B., Parras, A., Paster, A., Pedreira, J., Peña, J., Perea, R., Portas, B., Pulido, F., Rebollar, M., de Rivera, J., Roca, V., Rodríguez- Arrondo, F., Rubio, R., Santos, J., Sanz, J., Sebastian, G., Segovia, M., Tamargo, L., Viciana, P., von Wichmann, M., Bratt, G., Hollander, A., Olov Pehrson, P., Petz, I., Sandstrom, E., Sönnerborg, A., Gurtner, V., Ampunpong, U., Auchieng, C., Bowonwatanuwong, C., Chanchai, P., Chetchotisakd, P., Chuenyan, T., Duncombe, C., Horsakulthai, M., Kantipong, P., Laohajinda, K., Phanuphak, P., Pongsurachet, V., Pradapmook, S., Ruxruntham, K., Seekaew, S., Sonjai, A., Suwanagool, S., Techasathit, W., Ubolyam, S., Wankoon, J., Alexander, I., Dockrell, D., Easterbrook, P., Edwards, B., Evans, E., Fox, R., Gazzard, B., Gilleran, G., Hand, J., Heald, L., Higgs, C., Jebakumar, S., Jendrulek, I., Johnson, S., Kinghorn, G., Kuldanek, K., Maw, R., Mckernan, S., Mclean, L., Morris, S., O'Farrell, S., Ong, E., Peters, B., Stroud, C., Wansbrough-Jones, M., White, D., Williams, I., Wiselka, M., Yee, T., Adams, S., Allegra, D., Andrews, L., Aneja, B., Anstead, G., Artz, R., Bailowitz, J., Banks, S., Baum, J., Benator, D., Black, D., Boh, D., Bonam, T., Brito, M., Brockelman, J., Bruzzese, V., Burnside, A., Cafaro, V., Casey, K., Cason, L., Childress, G., Clark, C. L., Clifford, D., Climo, M., Couey, P., Cuervo, H., Deeks, S., Dennis, M., Diaz-Linares, M., Dickerson, D., Diez, M., Di Puppo, J., Dodson, P., Dupre, D., Elion, R., Elliott, K., El-Sadr, W., Estes, M., Fabre, J., Farrough, M., Flamm, J., Follansbee, S., Foster, C., Frank, C., Franz, J., Frechette, G., Freidland, G., Frische, J., Fuentes, L., Funk, C., Geisler, C., Genther, K., Giles, M., Goetz, M., Gonzalez, M., Graeber, C., Graziano, F., Grice, D., Hahn, B., Hamilton, C., Hassler, S., Henson, A., Hopper, S., John, M., Johnson, L., Johnson, R., Jones, R., Kahn, J., Klimas, N., Kolber, M., Koletar, S., Labriola, A., Larsen, R., Lasseter, F., Lederman, M., Ling, T., Lusch, T., Macarthur, R., Machado, C., Makohon, L., Mandelke, J., Mannheimer, S., Martínez, M., Martinez, N., Mass, M., Masur, H., Mcgregor, D., Mcintyre, D., Mckee, J., Mcmullen, D., Mettinger, M., Middleton, S., Mieras, J., Mildvan, D., Miller, P., Miller, T., Mitchell, V., Mitsuyasu, R., Moanna, A., Mogridge, C., Moran, F., Murphy, R., Nahass, R., Nixon, D., O'Brien, S., Ojeda, J., Okhuysen, P., Olson, M., Osterberger, J., Owen, W., Pablovich, Sr. S., Patel, S., Pierone, G., Poblete, R., Potter, A., Preston, E., Rappoport, C., Regevik, N., Reyelt, M., Riney, L., Rodriguez-Barradas, M., Rodriguez, M., Rodriguez, J., Roland, R., Rosmarin-DeStefano, C., Rossen, W., Rouff, J., Saag, M., Santiago, S., Sarria, J., Wirtz, S., Schmidt, U., Scott, C., Sheridan, A., Shin, A., Shrader, S., Simon, G., Slowinski, D., Smith, K., Spotkov, J., Sprague, C., States, D., Suh, C., Sullivan, J., Summers, K., Sweeton, B., Tan, V., Tanner, T., Temesgen, Z., Thomas, D., Thompson, M., Tobin, C., Toro, N., Towner, W., Upton, K., Uy, J., Valenti, S., van der Horst, C., Vita, J., Voell, J., Walker, J., Walton, T., Wason, K., Watson, V., Wellons, A., Weise, J., White, M., Whitman, T., Williams, B., Williams, N., Windham, J., Witt, M., Workowski, K., Wortmann, G., Wright, T., Zelasky, C., Zwickl, B., Dietz, D., Chesson, C., Schmetter, B., Grue, L., Willoughby, M., Demers, A., Dragsted, U. 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H., Masciottra, F., Michaan, M., Ruggieri, L., Salazar, E., Sánchez, M., Hoy, J. F., Rogers, G. D., Allworth, A. M., Anderson, J. S. C., Armishaw, J., Barnes, K., Chiam, A., Chuah, J. C. P., Curry, M. C., Dever, R. L., Donohue, W. A., Doong, N. C., Dwyer, D. E., Dyer, J., Eu, B., Ferguson, V. W., French, M. A. H., Garsia, R. J., Hudson, J. H., Jeganathan, S., Konecny, P., Mccormack, C. L., Mcmurchie, M., Moore, R. J., Moussa, M. B., Piper, M., Read, T., Roney, J. J., Shaw, D. R., Silvers, J., Smith, D. J., Street, A. C., Vale, R. J., Wendt, N. A., Wood, H., Youds, D. W., Zillman, J., Tozeau, V., de Roo, A., Leonard, P., Lynen, L., Moutschen, M., Pereira, L. C., Souza, T. N. L., Schechter, M., Zajdenverg, R., Almeida, M. M. T. B., Araujo, F., Bahia, F., Brites, C., Caseiro, M. M., Casseb, J., Etzel, A., Falco, G. G., Filho, E. C. J., Flint, S. R., Gonzales, C. R., Madruga, J. V. R., Passos, L. N., Reuter, T., Sidi, L. C., Toscano, A. L. C., Cherban, E., Conway, B., Dufour, C., Foster, A., Haase, D., Haldane, H., Klein, M., Lessard, B., Martel, A., Martel, C., Paradis, E., Schlech, W., Schmidt, S., Thompson, B., Vezina, S., Wolff Reyes, M. J., Northland, R., Hergens, L., Loftheim, I. R., Raukas, M., Justinen, J., Landman, R., Abel, S., Abgrall, S., Amat, K., Auperin, L., Barruet, R., Benalycherif, A., Benammar, N., Bentata, M., Besnier, J. M., Blanc, M., Cabié, A., Chavannet, P., Dargere, S., de la Tribonniere, X., Debord, T., Decaux, N., Delgado, J., Frixon-Marin, V., Genet, C., Gérard, L., Gilquin, J., Jeantils, V., Kouadio, H., Leclercq, P., Lelièvre, J. -D., Levy, Y., Michon, C. P., Nau, P., Pacanowski, J., Piketty, C., Salmon, D., Schmit, J. L., Serini, M. A., Tassi, S., Touam, F., Verdon, R., Weinbreck, P., Yazdanpanah, Y., Yeni, P., Bitsch, S., Bogner, J. R., Goebel, F. D., Lehmann, C., Lennemann, T., Potthof, A., Wasmuth, J. C., Wiedemeyer, K., Hatzakis, A., Touloumi, G., Antoniadou, A., Daikos, G. L., Dimitrakaki, A., Gargalianos-Kakolyris, P., Giannaris, M., Karafoulidou, A., Katsambas, A., Katsarou, O., Kontos, A. N., Kordossis, T., Lazanas, M. K., Panagopoulos, P., Paparizos, V., Papastamopoulos, V., Petrikkos, G., Skoutelis, A., Tsogas, N., Bergin, C. J., Mooka, B., Mamorksy, M. G., Agmon-Levin, N., Karplus, R., Shahar, E., Biglino, A., De Gioanni, M., Montroni, M., Raise, E., Honda, M., Ishisaka, M., Caplinskas, S., Uzdaviniene, V., Schmit, J. C., Mills, G. D., Blackmore, T., Masters, J. A., Morgan, J., Pithie, A., Brunn, J., Ormasssen, V., La Rosa, A., Guerra, O., Espichan, M., Gutierrez, L., Mendo, F., Salazar, R., Knytz, B., Kwiatkowski, J., Castro, R. S., Horta, A., Miranda, A. C., Pinto, I. V., Vera, J., Vinogradova, E., Yakovlev, A., Wood, R., Orrel, C., Arnaiz, J. A., Carrillo, R., Dalmau, D., Jordano, Q., Knobel, H., Larrousse, M., Moreno, J. S., Oretaga, E., Pena, J. N., Spycher, R., Bottone, S., Christen, A., Franc, C., Furrer, H. J., Gayet-Ageron, A., Genné, D., Hochstrasser, S., Moens, C., Nüesch, R., Ruxrungtham, K., Pumpradit, W., Dangthongdee, S., Kiertiburanakul, S., Klinbuayaem, V., Mootsikapun, P., Nonenoy, S., Piyavong, B., Prasithsirikul, W., Raksakulkarn, P., Gazzard, B. G., Ainsworth, J. G., Angus, B. J., Barber, T. J., Brook, M. G., Care, C. D., Chadwick, D. R., Chikohora, M., Churchill, D. R., Cornforth, D., Dockrell, D. H., Easterbrook, P. J., Fox, P. A., Gomez, P. A., Gompels, M. M., Harris, G. M., Herman, S., Jackson, A. G. A., Jebakumar, S. P. R., Kinghorn, G. R., Kuldanek, K. A., Larbalestier, N., Lumsden, M., Maher, T., Mantell, J., Muromba, L., Orkin, C. M., Peters, B. S., Peto, T. E. A., Portsmouth, S. D., Rajamanoharan, S., Ronan, A., Schwenk, A., Slinn, M. A., Stroud, C. J., Thomas, R. C., Wansbrough-Jones, M. H., Whiles, H. J., White, D. J., Williams, E., Williams, I. G., Acosta, E. A., Adamski, A., Antoniskis, D., Aragon, D. R., Barnett, B. J., Baroni, C., Barron, M., Baxter, J. D., Beers, D., Beilke, M., Bemenderfer, D., Bernard, A., Besch, C. L., Bessesen, M. T., Bethel, J. T., Blue, S., Blum, J. D., Boarden, S., Bolan, R. K., Borgman, J. B., Brar, I., Braxton, B. K., Bredeek, U. F., Brennan, R., Britt, D. E., Bulgin-Coleman, D., Bullock, D. E., Campbell, B., Caras, S., Carroll, J., Casey, K. K., Chiang, F., Cindrich, R. B., Clark, C., Cohen, C., Coley, J., Condoluci, D. V., Contreras, R., Corser, J., Cozzolino, J., Daley, L., Dandridge, D., D'Antuono, V., Darcourt Rizo Patron, J. G., Dehovitz, J. A., Dejesus, E., Desjardin, J., Dietrich, C., Dolce, E., Erickson, D., Faber, L. L., Falbo, J., Farrough, M. J., Farthing, C. F., Ferrell-Gonzalez, P., Flynn, H., Frank, M., Freeman, K. F., French, N., Fujita, N., Gahagan, L., Gilson, I., Goetz, M. B., Goodwin, E., Guity, C. K., Gulick, P., Gunderson, E. R., Hale, C. M., Hannah, K., Henderson, H., Hennessey, K., Henry, W. K., Higgins, D. T., Hodder, S. L., Horowitz, H. W., Howe-Pittman, M., Hubbard, J., Hudson, R., Hunter, H., Hutelmyer, C., Insignares, M. T., Jackson, L., Jenny, L., Johnson, D. L., Johnson, G., Johnson, J., Kaatz, J., Kaczmarski, J., Kagan, S., Kantor, C., Kempner, T., Kieckhaus, K., Kimmel, N., Klaus, B. M., Koeppe, J. R., Koirala, J., Kopka, J., Kostman, J. R., Kozal, M. J., Kumar, A., Lampiris, H., Lamprecht, C., Lattanzi, K. M., Lee, J., Leggett, J., Long, C., Loquere, A., Loveless, K., Lucasti, C. J., Macveigh, M., Makohon, L. H., Markowitz, N. P., Marks, C., Martorell, C., Mcfeaters, E., Mcgee, B., Mcintyre, D. M., Mcmanus, E., Melecio, L. G., Melton, D., Mercado, S., Merrifield, E., Mieras, J. A., Mogyoros, M., Moran, F. M., Murphy, K., Mutic, S., Nadeem, I., Nadler, J. P., Ognjan, A., O'Hearn, M., O'Keefe, K., Okhuysen, P. C., Oldfield, E., Olson, D., Orenstein, R., Ortiz, R., Parpart, F., Pastore-Lange, V., Paul, S., Pavlatos, A., Pearce, D. D., Pelz, R., Peterson, S., Pitrak, D., Powers, S. L., Pujet, H. C., Raaum, J. W., Ravishankar, J., Reeder, J., Reilly, N. A., Reyelt, C., Riddell, J., Rimland, D., Robinson, M. L., Rodriguez, A. E., Rodriguez-Barradas, M. C., Rodriguez Derouen, V., Rosmarin, C., Rossen, W. L., Rouff, J. R., Sampson, J. H., Sands, M., Savini, C., Schrader, S., Schulte, M. M., Scott, R., Seedhom, H., Sension, M., Sheble-Hall, A., Shuter, J., Slater, L. N., Slotten, R., Smith, M., Snap, S., States, D. M., Stringer, G., Summers, K. K., Swanson, K., Sweeton, I. B., Szabo, S., Tedaldi, E. M., Telzak, E. E., Thompson, M. A., Thompson, S., Ting Hong Bong, C., Vaccaro, A., Vasco, L. M., Vecino, I., Verlinghieri, G. K., Visnegarwala, F., Wade, B. H., Weis, S. E., Weise, J. A., Weissman, S., Wilkin, A. M., Witter, J. H., Wojtusic, L., Wright, T. J., Yeh, V., Young, B., Zeana, C., Zeh, J., Savio, E., Vacarezza, M., University College of London [London] (UCL), University of Copenhagen = Københavns Universitet (KU), University of New South Wales [Sydney] (UNSW), University of Amsterdam [Amsterdam] (UvA), University of Minnesota [Twin Cities] (UMN), University of Minnesota System, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Nice (CHU Nice), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Med Microbiol, Infect Dis & Infect Prev, RS: NUTRIM - R3 - Chronic inflammatory disease and wasting, RS: CAPHRI School for Public Health and Primary Care, RS: CAPHRI - R4 - Health Inequities and Societal Participation, Interne Geneeskunde, Chemical Biology, Mocroft, A, Lundgren, J, Ross, M, Law, M, Reiss, P, Kirk, O, Smith, C, Wentworth, D, Neuhaus, J, Fux, C, Moranne, O, Morlat, P, Johnson, M, Ryom, L, Gori, A, Internal medicine, CCA - Innovative therapy, ICaR - Circulation and metabolism, Medical Microbiology and Infection Prevention, CCA - Disease profiling, CCA - Immuno-pathogenesis, Plastic, Reconstructive and Hand Surgery, Mocroft, Amanda, Lundgren, Jens D., Ross, Michael, Law, Matthew, Reiss, Peter, Kirk, Ole, Smith, Colette, Wentworth, Deborah, Neuhaus, Jacqueline, Fux, Christoph A., Moranne, Olivier, Morlat, Phillipe, Johnson, Margaret A., Ryom, Lene, D:a:d Study, Group, Castagna, Antonella, the Royal Free Hospital Clinic, Cohort, and the, Insight, Smart, and ESPRIT, Study, Clinicum, Department of Medicine, Herrada, Anthony, University of Copenhagen = Københavns Universitet (UCPH), AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Global Health, Other departments, Infectious diseases, Paediatric Infectious Diseases / Rheumatology / Immunology, General Internal Medicine, Center of Experimental and Molecular Medicine, Graduate School, Gastroenterology and Hepatology, Dermatology, ACS - Amsterdam Cardiovascular Sciences, Other Research, Anesthesiology, and Bartlett, John
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Male ,Adult ,Age Factors ,Anti-HIV Agents ,CD4 Lymphocyte Count ,Clinical Decision-Making ,Comorbidity ,Female ,HIV ,HIV Infections ,HIV Seropositivity ,Humans ,Incidence ,Kidney ,Middle Aged ,Prospective Studies ,Renal Insufficiency, Chronic ,Risk ,Risk Assessment ,Sex Factors ,urologic and male genital diseases ,Biochemistry ,0302 clinical medicine ,ANTIRETROVIRAL THERAPY ,Adult, Age Factors, Anti-HIV Agents, CD4 Lymphocyte Count, Clinical Decision-Making, Comorbidity, Female, HIV, HIV Infections, HIV Seropositivity, Humans, Incidence, Kidney, Male, Middle Aged, Prospective Studies, Renal Insufficiency, Chronic, Risk, Risk Assessment, Sex Factors ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Age Factor ,Chronic ,STAGE RENAL-DISEASE ,PROTEINURIA ,virus diseases ,11 Medical And Health Sciences ,General Medicine ,ASSOCIATION ,6. Clean water ,female genital diseases and pregnancy complications ,3. Good health ,HIV/AIDS ,Medicine ,Infection ,psychological phenomena and processes ,Human ,medicine.medical_specialty ,Renal function ,NEFROPATIAS ,chronic kidney disease ,risk score model ,12. Responsible consumption ,ESPRIT study group ,03 medical and health sciences ,SDG 3 - Good Health and Well-being ,Clinical Research ,D:A:D study group ,Intensive care medicine ,medicine (all) ,Molecular Biology ,Royal Free Hospital Clinic Cohort ,Prevention ,Anti-HIV Agent ,medicine.disease ,Prospective Studie ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Immunology ,Kidney Disease ,PREDICTION ,POSITIVE PERSONS ,030232 urology & nephrology ,Sex Factor ,SDG 3 – Goede gezondheid en welzijn ,Medical and Health Sciences ,GLOMERULAR-FILTRATION-RATE ,[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,INSIGHT study group ,HIV Infection ,LIFE EXPECTANCY ,030212 general & internal medicine ,Renal Insufficiency ,Prospective cohort study ,Framingham Risk Score ,Incidence (epidemiology) ,adult ,age factors ,anti-hiv agents ,CD4 lymphocyte count ,clinical decision-making ,comorbidity ,female ,hiv ,hiv infections ,hiv seropositivity ,humans ,incidence ,kidney ,male ,middle aged ,prospective studies ,renal insufficiency, chronic ,risk ,risk assessment ,sex factors ,SMART study group ,6.1 Pharmaceuticals ,[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Patient Safety ,Risk assessment ,Biotechnology ,Research Article ,Settore MED/17 - MALATTIE INFETTIVE ,NO ,A:D study group [D] ,General & Internal Medicine ,Diabetes mellitus ,mental disorders ,medicine ,EXPOSURE ,business.industry ,Evaluation of treatments and therapeutic interventions ,Cell Biology ,[SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,INDIVIDUALS ,Good Health and Well Being ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,3121 General medicine, internal medicine and other clinical medicine ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,Kidney disease - Abstract
Background Chronic kidney disease (CKD) is a major health issue for HIV-positive individuals, associated with increased morbidity and mortality. Development and implementation of a risk score model for CKD would allow comparison of the risks and benefits of adding potentially nephrotoxic antiretrovirals to a treatment regimen and would identify those at greatest risk of CKD. The aims of this study were to develop a simple, externally validated, and widely applicable long-term risk score model for CKD in HIV-positive individuals that can guide decision making in clinical practice. Methods and Findings A total of 17,954 HIV-positive individuals from the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study with ≥3 estimated glomerular filtration rate (eGFR) values after 1 January 2004 were included. Baseline was defined as the first eGFR > 60 ml/min/1.73 m2 after 1 January 2004; individuals with exposure to tenofovir, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, other boosted protease inhibitors before baseline were excluded. CKD was defined as confirmed (>3 mo apart) eGFR ≤ 60 ml/min/1.73 m2. Poisson regression was used to develop a risk score, externally validated on two independent cohorts. In the D:A:D study, 641 individuals developed CKD during 103,185 person-years of follow-up (PYFU; incidence 6.2/1,000 PYFU, 95% CI 5.7–6.7; median follow-up 6.1 y, range 0.3–9.1 y). Older age, intravenous drug use, hepatitis C coinfection, lower baseline eGFR, female gender, lower CD4 count nadir, hypertension, diabetes, and cardiovascular disease (CVD) predicted CKD. The adjusted incidence rate ratios of these nine categorical variables were scaled and summed to create the risk score. The median risk score at baseline was −2 (interquartile range –4 to 2). There was a 1:393 chance of developing CKD in the next 5 y in the low risk group (risk score < 0, 33 events), rising to 1:47 and 1:6 in the medium (risk score 0–4, 103 events) and high risk groups (risk score ≥ 5, 505 events), respectively. Number needed to harm (NNTH) at 5 y when starting unboosted atazanavir or lopinavir/ritonavir among those with a low risk score was 1,702 (95% CI 1,166–3,367); NNTH was 202 (95% CI 159–278) and 21 (95% CI 19–23), respectively, for those with a medium and high risk score. NNTH was 739 (95% CI 506–1462), 88 (95% CI 69–121), and 9 (95% CI 8–10) for those with a low, medium, and high risk score, respectively, starting tenofovir, atazanavir/ritonavir, or another boosted protease inhibitor. The Royal Free Hospital Clinic Cohort included 2,548 individuals, of whom 94 individuals developed CKD (3.7%) during 18,376 PYFU (median follow-up 7.4 y, range 0.3–12.7 y). Of 2,013 individuals included from the SMART/ESPRIT control arms, 32 individuals developed CKD (1.6%) during 8,452 PYFU (median follow-up 4.1 y, range 0.6–8.1 y). External validation showed that the risk score predicted well in these cohorts. Limitations of this study included limited data on race and no information on proteinuria. Conclusions Both traditional and HIV-related risk factors were predictive of CKD. These factors were used to develop a risk score for CKD in HIV infection, externally validated, that has direct clinical relevance for patients and clinicians to weigh the benefits of certain antiretrovirals against the risk of CKD and to identify those at greatest risk of CKD., Editors’ Summary Background About 35 million people are currently infected with HIV, the virus that causes AIDS. HIV destroys CD4 lymphocytes and other immune system cells, leaving infected individuals susceptible to other infections. HIV infection can be controlled, but not cured, using combination antiretroviral therapy (cART), and, nowadays, the life expectancy of many HIV-positive individuals is similar to that of HIV-negative people. HIV-positive individuals nevertheless experience some illnesses more frequently than HIV-negative people do. For example, up to a third of HIV-positive individuals develop chronic kidney disease (CKD), which is associated with an increased risk of cardiovascular disease and death. Persons with CKD may have an impaired effect of the filtration units in the kidneys that remove waste products and excess water from the blood to make urine, thereby leading to a reduced blood filtration rate (the estimated glomerular filtration rate [eGFR]) and waste product accumulation in the blood. Symptoms of CKD, which rarely occur until the disease is advanced, include tiredness, swollen feet, and frequent urination. Advanced stages of CKD cannot be cured, but its progression can be slowed by, for example, controlling hypertension (high blood pressure) and diabetes (two CDK risk factors) and by adopting a healthy lifestyle. Why Was This Study Done? The burden of CKD may increase among HIV-positive individuals as they age, and clinicians need to know which individuals are at high risk of developing CKD when choosing cART regimens for their patients. In addition, clinicians need to be able to identify those HIV-positive individuals at greatest risk of CKD so that they can monitor them for early signs of kidney disease. Some antiretroviral drugs—for example, tenofovir and atazanavir/ritonavir (a boosted protease inhibitor)—are associated with kidney damage. Clinicians may need to weigh the benefits and risks of giving such potentially nephrotoxic drugs to individuals who already have a high CKD risk. Here, the researchers develop and validate a simple, widely applicable risk score (a risk prediction model) for CKD among HIV-positive individuals and investigate the relationship between CKD and potentially nephrotoxic antiretroviral drugs among individuals with different CKD risk score profiles. What Did the Researchers Do and Find? To develop their CKD risk score, the researchers used clinical and demographic data collected from 17,954 HIV-positive individuals enrolled in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study who had an eGFR > 60 ml/min/1.73 m2 and were not taking a potentially nephrotoxic antiretroviral at baseline. During 103,185 person-years of follow-up, 641 individuals developed CKD. Older age, intravenous drug use, hepatitis C coinfection, lower baseline eGFR, female gender, lower CD4 count nadir, hypertension, diabetes, and cardiovascular disease predicted CKD. The researchers included these nine factors in their risk score model (which is available online) and defined three risk groups: low (risk score < 0), medium (risk score 0–4), and high (risk score ≥ 5) risk of CKD development in the next five years. Specifically, there was a 1 in 393, 1 in 47, and 1 in 6 chance of developing CKD in the next five years in the low, medium, and high risk groups, respectively. Because some patients started to use potentially nephrotoxic antiretroviral drugs during follow-up, the researchers were able to use their risk score model to calculate how many patients would have to be treated with one of these drugs for an additional patient to develop CKD over five years in each risk group. This “number needed to harm” (NNTH) for patients starting treatment with tenofovir, atazanavir/ritonavir, or another boosted protease inhibitor was 739, 88, and 9 in the low, medium, and high risk groups, respectively. Finally, the researchers validated the accuracy of their risk score in two independent HIV study groups. What Do These Findings Mean? These findings provide a simple, validated risk score for CKD and indicate that the NNTH when starting potentially nephrotoxic antiretrovirals was low among HIV-positive individuals at the highest risk of CKD (i.e., treating just nine individuals with nephrotoxic antiretroviral drugs will likely lead to an additional case of CKD in five years). Although various aspects of the study, including the lack of data on race, limit the accuracy of these findings, these findings highlight the need for monitoring, screening, and chronic disease prevention to minimize the risk of HIV-positive individuals developing diabetes, hypertension, or cardiovascular disease, or becoming coinfected with hepatitis C, all of which contribute to the CKD risk score. Moreover, the development of a tool for estimating an individual’s five-year risk of developing CKD with or without the addition of potentially nephrotoxic antiretroviral drugs will enable clinicians and patients to weigh the benefits of certain antiretroviral drugs against the risk of CKD and make informed decisions about treatment options. Additional Information Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001809. Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS NAM/aidsmap provides basic information about HIV/AIDS, summaries of recent research findings on HIV care and treatment, and personal stories about living with AIDS/HIV Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including personal stories about living with HIV/AIDS The World Health Organization provides information on all aspects of HIV/AIDS (in several languages), including its guidelines on the use of ART for treating and preventing HIV infection The UNAIDS World AIDS Day Report 2014 provides up-to-date information about the AIDS epidemic and efforts to halt it The UK National Health Service Choices website provides information for patients on chronic kidney disease, including some personal stories The US National Kidney Foundation, a not-for-profit organization, provides information about chronic kidney disease (in English and Spanish) A tool for calculating the CDK risk score developed in this study is available Additional information about the D:A:D study is available, Amanda Mocroft and colleagues develop and validate a model for determining risk of developing chronic kidney disease for individuals with HIV if treated with different antiretroviral therapies.
- Published
- 2015
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