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5. Genotypic testing on HIV-1 DNA as a tool to assess HIV-1 co-receptor usage in clinical practice: results from the DIVA study group

Author

Svicher, V., Alteri, C., Montano, M., Nori, A., D’Arrigo, R., Andreoni, M., Angarano, G., Antinori, A., Antonelli, G., Allice, T., Bagnarelli, P., Baldanti, F., Bertoli, A., Borderi, M., Boeri, E., Bon, I., Bruzzone, B., Barresi, R., Calderisi, S., Callegaro, A. P., Capobianchi, M. R., Gargiulo, F., Castelli, F., Cauda, R., Ceccherini-Silberstein, F., Clementi, M., Chirianni, A., Colafigli, M., D’Arminio Monforte, A., De Luca, A., Di Biagio, A., Di Nicuolo, G., Di Perri, G., Di Santo, F., Fadda, G., Galli, M., Gennari, W., Ghisetti, V., Costantini, A., Gori, A., Gulminetti, R., Leoncini, F., Maffongelli, G., Maggiolo, F., Maserati, R., Mazzotta, F., Meini, G., Micheli, V., Monno, L., Mussini, C., Nozza, S., Paolucci, S., Palù, G., Parisi, S., Parruti, G., Pignataro, A. R., Quirino, T., Re, M. C., Rizzardini, G., Sanguinetti, M., Santangelo, R., Scaggiante, R., Sterrantino, G., Turriziani, O., Vatteroni, M. L., Viscoli, C., Vullo, V., Zazzi, M., Lazzarin, A., and Perno, C. F.

Published
2014
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7. Longitudinal analysis of HIV-1 coreceptor tropism by single and triplicate HIV-1 RNA and DNA sequencing in patients undergoing successful first-line antiretroviral therapy

Author

Meini, G., Rossetti, B., Bianco, C., Ceccherini-Silberstein, F., Di Giambenedetto, S., Sighinolfi, L., Monno, L., Castagna, A., Rozera, G., D'Arminio Monforte, A., Zazzi, M., De Luca, A., Moroni, M., Angarano, G., Antinori, A., Armignacco, O., 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., Cozzi-Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Andreoni, M., Ammassari, A., Balotta, C., Bonfanti, P., Bonora, S., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Maggiolo, F., Marchetti, G., Marcotullio, S., Quiros Roldan, E., Rusconi, S., Cicconi, P., Fanti, I., 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, P. E., Piano, P., Vecchiet, J., Falasca, K., Segala, D., Mazzotta, F., Cassola, G., Viscoli, G., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. 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., Mura, M. S., Caramello, P., Orofino, G. C., Sciandra, M., Pellizzer, G., Manfrin, V., Meini, Genny, Rossetti, Barbara, Bianco, Claudia, ICONA Fdn, Grp, Castagna, Antonella, Meini, G, Rossetti, B, Bianco, C, Ceccherini Silberstein, F, Di Giambenedetto, S, Sighinolfi, L, Monno, L, Castagna, A, Rozera, G, D'arminio Monforte, A, Zazzi, M, De Luca, A, Moroni, M, Armignacco, O, Iardino, R, Ippolito, G, Perno, C, Von Schloesser, F, Cozzi Lepri, A, Girardi, E, Balotta, C, Borderi, M, Capobianchi, M, Cinque, P, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Marcotullio, S, Rusconi, S, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantini, A, Angarano, G, Santoro, C, Maggiolo, F, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Castelli, F, Quiros Roldan, E, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Segala, D, Mazzotta, F, Lo Caputo, S, Cassola, G, Viscoli, G, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Bonfanti, P, Caramma, I, Castelli, A, Galli, M, Lazzarin, A, Rizzardini, G, Puoti, M, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Cicconi, P, Marchetti, G, Mussini, C, Puzzolante, C, Gori, A, Lapadula, G, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Cauda, R, Andreoni, M, Antinori, A, Vullo, V, Cingolani, A, D'Avino, A, Ammassari, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Mura, M, Madeddu, G, Caramello, P, Di Perri, G, Orofino, G, Bonora, S, Sciandra, M, Pellizzer, G, and Manfrin, V

Subjects
Male, viruses, Salvage therapy, HIV Infections, Cohort Studies, chemistry.chemical_compound, 0302 clinical medicine, Genotype interpretation, gp120, HIV type 1, V3, Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, DNA, Viral, Female, Genotype, HIV-1, Humans, RNA, Viral, Sequence Analysis, DNA, Viral Tropism, Pharmacology, Pharmacology (medical), Infectious Diseases, Medicine (all), HIV Infection, Viral, 030212 general & internal medicine, Original Research, 0303 health sciences, tropism, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, 3. Good health, genotype interpretation, Sequence Analysis, Human, Microbiology (medical), antiretroviral therapy, Antiretroviral Therapy, Viremia, Infectious Disease, CCR5 receptor antagonist, Biology, HIV infection, Settore MED/17 - MALATTIE INFETTIVE, NO, 03 medical and health sciences, medicine, Highly Active, Tropism, Maraviroc, 030306 microbiology, RNA, DNA, medicine.disease, Virology, chemistry, Immunology, Tissue tropism, Anti-Retroviral Agent, Cohort Studie
Abstract

Objectives: Maraviroc has been shown to be effective in patients harbouring CCR5-tropic HIV-1. While this CCR5 antagonist has initially been used in salvage therapy, its excellent safety profile makes it ideal for antiretroviral treatment simplification strategies in patients with suppressed plasma viraemia. The aim of this study was to compare HIV-1 tropism as detected in baseline plasma RNA and peripheral blood mononuclear cell (PBMC) DNA prior to first-line therapy and to analyse tropism evolution while on successful treatment. Methods: HIV-1 tropism was determined using triplicate genotypic testing combined with geno2pheno[coreceptor] analysis at a 10% false positive rate in 42 patients. Paired pre-treatment plasma RNA and PBMC DNA and two subsequent PBMC DNA samples (the first obtained after reaching undetectable plasma HIV-1 RNA and the second after at least 2 years of suppression of plasma viraemia) were evaluated. Results: Coreceptor tropism was completely concordant in paired pre-treatment RNA and DNA, with 26.2% of HIV-1 sequences predicted to be non-CCR5-tropic. During follow-up, coreceptor tropism switches were detected in 4 (9.5%) patients without any preferential direction. Although false positive rate discrepancies within triplicates were common, the rate of discordance of coreceptor tropism assignment among triplicate results in this mostly CCR5-tropic dataset was only 2.1%, questioning the added value of triplicate testing compared with single testing. Conclusions: HIV-1 coreceptor tropism changes during virologically successful first-line treatment are infrequent. HIV-1 DNA analysis may thus support the choice of a CCR5 antagonist in treatment switch strategies; however, maraviroc treatment outcome data are required to confirm this option. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved

Published
2013
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8. Low Rate of Virological Failure and Maintenance of Susceptibility to HIV-1 Protease Inhibitors with First-Line Lopinavir/Ritonavir-Based Antiretroviral Treatment in Clinical Practice

Author

Prosperi, Mc, Zazzi, M, Punzi, G, Monno, L, Colao, G, Corsi, P, Di Giambenedetto, S, Meini, G, Ghisetti, V, Bonora, S, Pecorari, M, Gismondo, Mr, Bagnarelli, P, Carli, T, De Luca, A, ARCA Collaborative Group, Giacometti, A, Butini, L, del Gobbo, R, Menzo, S, Tacconi, D, Corbelli, G, Zanussi, S, Maggiolo, F, Callegaro, A, Calza, L, Re, Mc, Raffaele, P, Turconi, P, Mandas, A, Tini, S, Zoncada, A, Paolini, E, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Galli, L, Di Pietro, M, Bartalesi, F, Tosti, A, Di Biagio, A, Setti, M, Bruzzone, B, Penco, G, Trezzi, M, Orani, A, Pardelli, R, De Gennaro, M, Chiodera, A, Scalzini, A, Palvarini, L, Almi, P, Todaro, G, Monforte, A, Cicconi, P, Rusconi, S, Micheli, V, Biondi, Ml, Gianotti, N, Capetti, A, Meraviglia, P, Boeri, E, Mussini, C, Soria, A, Vecchi, L, Santirocchi, M, Brustia, D, Ravanini, P, Dal Bello, F, Romano, N, Mancuso, S, Calzetti, C, Maserati, R, Filice, G, Baldanti, F, Francisci, D, Parruti, G, Polilli, E, Sacchini, D, Martinelli, C, Consolini, Rita, Clinic of Infectious Diseases, Università cattolica del Sacro Cuore [Roma] (Unicatt), Molecular Biology, Microbiology and Virology, Bari University Hospital, Clinical Infectious Diseases, Careggi University Hospital, Unit of Infectious Diseases, Catholic Universisty of Sacred Heart, A. Savoia Hospital, infectiuos diseases, Università degli studi di Torino (UNITO), Modena University Hospital, L. Sacco University Hospital, Ancona University Hospital, Grosseto General Hospital, Institute of Infectious Diseases, Sacro Cuore Catholic University, Infectious Diseases Unit, University Hospital of Siena, Prosperi, M, Zazzi, M, Punzi, G, Monno, L, Colao, G, Corsi, P, Di Giambenedetto, S, Meini, G, Ghisetti, V, Bonora, S, Pecorari, M, Gismondo, M, Bagnarelli, P, Carli, T, De Luca, A, Mancuso, S, Prosperi MC, Zazzi M, Punzi G, Monno L, Colao G, Corsi P, Di Giambenedetto S, Meini G, Ghisetti V, Bonora S, Pecorari M, Gismondo MR, Bagnarelli P, Carli T, De Luca A, ARCA Collaborative Group [.., Giacometti A, Butini L, del Gobbo R, Menzo S, Tacconi D, Corbelli G, Zanussi S, Maggiolo F, Callegaro A, Calza L, Re MC, Raffaele P, Turconi P, Mandas A, Tini S, Zoncada A, Paolini E, Amadio G, Sighinolfi L, and ]

Subjects
Male, Lopinavir/ritonavir, HIV Infections, boosted protease inhibitor, Lopinavir, Cohort Studies, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, virologic failure, HIV Infection, Treatment Failure, 030212 general & internal medicine, Pyrimidinone, 0303 health sciences, education.field_of_study, lopinavir/ritonavir, Viral Load, Resistance mutation, first-line antiretroviral therapy, Reverse Transcriptase Inhibitor, 3. Good health, Treatment Outcome, Infectious Diseases, RNA, Viral, Reverse Transcriptase Inhibitors, Medicine, Drug Therapy, Combination, Female, Survival Analysi, Viral load, Human, medicine.drug, Anti-HIV Agents, Population, Pyrimidinones, Settore MED/17 - MALATTIE INFETTIVE, Emtricitabine, human immunodeficiency virus type 1, 03 medical and health sciences, Virology, Drug Resistance, Viral, antiretroviral drug resistance, medicine, Humans, Protease inhibitor (pharmacology), education, HIV Protease Inhibitor, Ritonavir, 030306 microbiology, business.industry, Anti-HIV Agent, HIV Protease Inhibitors, Survival Analysis, HIV-1, Cohort Studie, business
Abstract

Protease inhibitor (PI)-resistant HIV-1 has hardly ever been detected at failed boosted PI-based first-line antiretroviral regimens in clinical trials. However, this phenomenon has not been investigated in clinical practice. To address this gap, data from patients starting a first-line lopinavir/ritonavir (LPV/rtv)-based therapy with available baseline HIV-1 RNA load, a viral genotype and follow-up viral load after 3 and 6 months of treatment were extracted from the Italian Antiretroviral Resistance Cohort Analysis (ARCA) observational database. Based on survival analysis, 39 (7.1%) and 43 (7.8%) of the 548 examined patient cases had an HIV-1 RNA >500 and >50 copies/ml, respectively, after 6 months of treatment. Cox proportional hazard models detected baseline HIV-1 RNA (RH 1.79, 95%CI 1.10-2.92 per 1 - log10 increase, P = 0.02) and resistance to the nucleoside backbone (RH 1.04, 95%CI 1.02-1.06 per 10-point increase using the Stanford HIVdb algorithm, P < 0.001) as independent predictors of HIV-1 RNA at >500 copies/ml, but not at the >50 copies/ml cutoff criteria. Higher baseline viral load, older patient age, heterosexual route of infection and use of tenofovir/emtricitabine were predictors of failure at month 3 using the 50-copy and/or 500-copy threshold. Resistance to LPV/rtv did not occur or increase in any of the available 36 follow-up HIV-1 genotypes. Resistance to the nucleoside backbone (M184V) developed in four cases. Despite the likely differences in patient population and adherence, both the low rate of virological failure and the lack of development of LPV/rtv resistance documented in clinical trials are thus confirmed in clinical practice. J. Med. Virol. 82:1996-2003, 2010. © 2010 Wiley-Liss, Inc.

Published
2010
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9. A Prognostic Model for Estimating the Time to Virologic Failure in HIV-1 Infected Patients Undergoing a New Combination Antiretroviral Therapy Regimen

Author

PProsperi MC, Di Giambenedetto S, Fanti I, Meini G, Bruzzone B, Callegaro A, Penco G, Bagnarelli P, Micheli V, Paolini E, Di Biagio A, Ghisetti V, Di Pietro M, Zazzi M, De Luca A, Giacometti A, Butini L, del Gobbo R, Menzo S, Tacconi D, Corbelli G, Zanussi S, Monno L, Punzi G, Maggiolo F, CALZA, LEONARDO, RE, MARIA CARLA, Pristerà R, Turconi P, Mandas A, Tini S, Carnevale G, Amadio G, Sighinolfi L, Zuccati G, Morfini M, Manetti R, Galli L, Bartalesi F, Colao G, Tosti A, Setti M, Trezzi M, Orani A, Pardelli R, De Gennaro M, Chiodera A, Scalzini A, Palvarini L, Almi P, Todaro G, Gianotti N, Cicconi P, Rusconi S, Gismondo MR, Biondi ML, Capetti A, Meraviglia P, Boeri E, Pecorari M, Mussini C, Santirocchi M, Brustia D, Ravanini P, Dal Bello F, Romano N, Mancuso S, Calzetti C, Maserati R, Baldanti F, Francisci D, Parruti G, Polilli E, Sacchini D, Martinelli C, Consolini R, Vatteroni L, Vivarelli A, Nerli A, Lenzi L, Magnani G, Ortolani P, Andreoni M, Palamara G, Fimiani C, Palmisano L, Antinori A, Vullo V, Turriziani O, Perno CF, Montano M, Cenderello G, Gonnelli A, Romano L, Palumbo M, Bonora S, Delle Foglie P, Rossi C, Poletti F, Mondino V, Malena M, Lattuada E., PProsperi MC, Di Giambenedetto S, Fanti I, Meini G, Bruzzone B, Callegaro A, Penco G, Bagnarelli P, Micheli V, Paolini E, Di Biagio A, Ghisetti V, Di Pietro M, Zazzi M, De Luca A, Giacometti A, Butini L, del Gobbo R, Menzo S, Tacconi D, Corbelli G, Zanussi S, Monno L, Punzi G, Maggiolo F, Calza L, Re MC, Pristerà R, Turconi P, Mandas A, Tini S, Carnevale G, Amadio G, Sighinolfi L, Zuccati G, Morfini M, Manetti R, Galli L, Bartalesi F, Colao G, Tosti A, Setti M, Trezzi M, Orani A, Pardelli R, De Gennaro M, Chiodera A, Scalzini A, Palvarini L, Almi P, Todaro G, Gianotti N, Cicconi P, Rusconi S, Gismondo MR, Biondi ML, Capetti A, Meraviglia P, Boeri E, Pecorari M, Mussini C, Santirocchi M, Brustia D, Ravanini P, Dal Bello F, Romano N, Mancuso S, Calzetti C, Maserati R, Baldanti F, Francisci D, Parruti G, Polilli E, Sacchini D, Martinelli C, Consolini R, Vatteroni L, Vivarelli A, Nerli A, Lenzi L, Magnani G, Ortolani P, Andreoni M, Palamara G, Fimiani C, Palmisano L, Antinori A, Vullo V, Turriziani O, Perno CF, Montano M, Cenderello G, Gonnelli A, Romano L, Palumbo M, Bonora S, Delle Foglie P, Rossi C, Poletti F, Mondino V, Malena M, Lattuada E., Prosperi, M, Di Giambenedetto, S, Fanti, I, Meini, G, Bruzzone, B, Callegaro, A, Penco, G, Bagnarelli, P, Micheli, V, Paolini, E, Di Biagio, A, Ghisetti, V, Di Pietro, M, Zazzi, M, De Luca, A, and Mancuso, S

Subjects
Oncology, Male, Adult, Anti-HIV Agents, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections, HIV-1, Humans, Middle Aged, Proportional Hazards Models, Treatment Failure, Viral Load, 0302 clinical medicine, ANTIRETROVIRAL THERAPY, Medicine, HIV Infection, 030212 general & internal medicine, 0303 health sciences, Health Policy, 3. Good health, Computer Science Applications, Censoring (clinical trials), Cohort, Combination, lcsh:R858-859.7, Viral load, Human, Research Article, Cart, medicine.medical_specialty, antiretroviral therapy, Health Informatics, Settore MED/17 - MALATTIE INFETTIVE, lcsh:Computer applications to medicine. Medical informatics, 03 medical and health sciences, Drug Therapy, Internal medicine, Survival analysis, 030306 microbiology, business.industry, Proportional hazards model, ANTIRETROVIRAL DRUGS, Anti-HIV Agent, HIV, GENOTYPES, Discontinuation, Regimen, Immunology, Proportional Hazards Model, Cohort Studie, business
Abstract

Background HIV-1 genotypic susceptibility scores (GSSs) were proven to be significant prognostic factors of fixed time-point virologic outcomes after combination antiretroviral therapy (cART) switch/initiation. However, their relative-hazard for the time to virologic failure has not been thoroughly investigated, and an expert system that is able to predict how long a new cART regimen will remain effective has never been designed. Methods We analyzed patients of the Italian ARCA cohort starting a new cART from 1999 onwards either after virologic failure or as treatment-naïve. The time to virologic failure was the endpoint, from the 90th day after treatment start, defined as the first HIV-1 RNA > 400 copies/ml, censoring at last available HIV-1 RNA before treatment discontinuation. We assessed the relative hazard/importance of GSSs according to distinct interpretation systems (Rega, ANRS and HIVdb) and other covariates by means of Cox regression and random survival forests (RSF). Prediction models were validated via the bootstrap and c-index measure. Results The dataset included 2337 regimens from 2182 patients, of which 733 were previously treatment-naïve. We observed 1067 virologic failures over 2820 persons-years. Multivariable analysis revealed that low GSSs of cART were independently associated with the hazard of a virologic failure, along with several other covariates. Evaluation of predictive performance yielded a modest ability of the Cox regression to predict the virologic endpoint (c-index≈0.70), while RSF showed a better performance (c-index≈0.73, p < 0.0001 vs. Cox regression). Variable importance according to RSF was concordant with the Cox hazards. Conclusions GSSs of cART and several other covariates were investigated using linear and non-linear survival analysis. RSF models are a promising approach for the development of a reliable system that predicts time to virologic failure better than Cox regression. Such models might represent a significant improvement over the current methods for monitoring and optimization of cART.

Published
2011
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12. Performance of genotypic tropism testing on proviral DNAin clinical practice: results from the DIVA Study Group

Author

Svicher, V, Alteri, C, Montano, M, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Callegaro, Ap, Capobianchi, Mr, Carosi, G, Cauda, R, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, M, D'Arminio Monforte, A, De Luca, A, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Pietro, M, Di Santo, F, Fabeni, L, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, C, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Manca, G, Gargiulo, F, Martinelli, C, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Narciso, P, Nozza, S, Paolucci, S, Pal, G, Parisi, S, Parruti, G, Pignataro, Ar, Pollicita, M, Quirino, T, Re, Mc, Rizzardini, G, Santangelo, R, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, Ml, Vecchi, L, Viscoli, Claudio, Vullo, V, Zazzi, M, Lazzarini, A, and Perno, Cf

Subjects
HIV, Proviral DNA, Tropism
Published
2012

13. A prognostic model for estimating the time to virologic failure in HIV-1 infected patients undergoing a new combination antiretroviral therapy regimen

Author

Prosperi, Mc, Di Giambenedetto, S, Fanti, I, Meini, G, Bruzzone, B, Callegaro, A, Penco, G, Bagnarelli, P, Micheli, V, Paolini, E, Di Biagio, A, Ghisetti, V, Di Pietro, M, Zazzi, M, De Luca, A, CollaboratorsGiacometti A, ARCA c. o. h. o. r. t., Butini, L, del Gobbo, R, Menzo, S, Tacconi, D, Corbelli, G, Zanussi, S, Monno, L, Punzi, G, Maggiolo, F, Calza, L, Re, Mc, Pristerà, R, Turconi, P, Potenza, D, Mandas, A, Tini, S, Zoncada, A, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Corsi, P, Galli, L, Bartalesi, F, Colao, G, Tosti, A, Setti, M, Trezzi, M, Orani, A, Pardelli, R, Arcidiacono, I, Degiuli, A, De Gennaro, M, Chiodera, A, Scalzini, A, Palvarini, L, Almi, P, Todaro, G, Gianotti, N, Cicconi, P, Rusconi, S, Gismondo, Mr, Biondi, Ml, Capetti, A, Meraviglia, P, Boeri, E, Pecorari, M, Soria, A, Vecchi, L, Mussini, C, Santirocchi, M, Brustia, D, Ravanini, P, Dal Bello, F, Romano, N, Mancuso, S, Calzetti, C, Maserati, R, Filice, G, Baldanti, F, Francisci, D, Parruti, G, Polilli, E, Sacchini, D, Martinelli, C, and Consolini, Rita

Published
2011

14. Update on emergence of HIV-1 resistance to antiretroviral drug classes in an Italian national database: 2007-2009

Author

Di Giambenedetto, S, Prosperi, M, Fanti, I, Bruzzone, B, Paolucci, S, Penco, G, Meini, G, Di Biagio, A, Paolini, E, Micheli, V, Meraviglia, P, Castelli, P, Corsi, P, Gonnelli, A, Fabbiani, M, Zazzi, M, De Luca, A, on behalf of the ARCA Collaborative Group, and Consolini, Rita

Subjects
Male, Databases, Factual, medicine.medical_treatment, Human immunodeficiency virus (HIV), Drug resistance mutations, Drug Resistance, HIV Infections, Drug resistance, medicine.disease_cause, Logistic regression, Nucleoside Reverse Transcriptase Inhibitor, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Prevalence, 030212 general & internal medicine, Viral, Treatment Failure, Human immunodeficiency virus-1, media_common, 0303 health sciences, General Medicine, Middle Aged, 3. Good health, Antiretroviral therapy, Adult, Anti-HIV Agents, Drug Resistance, Viral, Female, Humans, Italy, Logistic Models, HIV-1, Infectious Diseases, Drug, Microbiology (medical), medicine.medical_specialty, media_common.quotation_subject, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Databases, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Highly Active, Factual, Protease, 030306 microbiology, business.industry, medicine.disease, Virology, National database, business
Abstract

We analysed trends of human immunodeficiency virus type 1 (HIV-1) drug resistance during 2007–2009 in the Italian national HIV drug resistance database ‘ARCA'. Prevalence of resistance in each year was examined on the basis of the presence of major International AIDS Society-2009 mutations. Predictors of resistance were analysed by multivariable logistic regression. Nine hundred and sixty-six patients were selected. Resistance to nucleoside reverse transcriptase inhibitors and protease inhibitors showed a significant decline with respect to previous surveys. Resistance to any class of drug and three drug classes remained stable. Independent predictors of three-class resistance were the number of treatment regimens experienced, prior suboptimal nucleoside reverse transcriptase inhibitor therapy and the current use of ritonavir-boosted protease inhibitors.

Published
2011

15. Acute hyperglycemia and cardiac conduction

Author

MARFELLA, Raffaele, Nappo F, Meini G, Celiento G, Siniscalchi M, GIUGLIANO, Dario, Marfella, Raffaele, Nappo, F, Meini, G, Celiento, G, Siniscalchi, M, and Giugliano, Dario

Published
1999

17. Low rate of virological failure and maintenance of susceptibility to HIV-1 protease inhibitors with first-line lopinavir/ritonavir-based antiretroviral treatment in clinical practice

Author

Prosperi, Mc1, Zazzi, M, Punzi, G, Monno, L, Colao, G, Corsi, P, Di Giambenedetto, S, Meini, G, Ghisetti, V, Bonora, S, Pecorari, M, Gismondo, Mr, Bagnarelli, P, Carli, T, De Luca, A, Collaborators Giacometti A, ARCA Collaborative G. r. o. u. p., Butini, L, del Gobbo, R, Menzo, S, Tacconi, D, Corbelli, G, Zanussi, S, Maggiolo, F, Callegaro, A, Calza, L, Re, Mc, Raffaele, P, Turconi, P, Mandas, A, Tini, S, Zoncada, A, Paolini, E, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Galli, L, Di Pietro, M, Bartalesi, F, Tosti, A, Di Biagio, A, Setti, M, Bruzzone, B, Penco, G, Trezzi, M, Orani, A, Pardelli, R, De Gennaro, M, Chiodera, A, Scalzini, A, Palvarini, L, Almi, P, Todaro, G, Monforte, Ad, Cicconi, P, Rusconi, S, Micheli, V, Biondi, Ml, Gianotti, N, Capetti, A, Meraviglia, P, Boeri, E, Mussini, C, Soria, A, Vecchi, L, Santirocchi, M, Brustia, D, Ravanini, P, Dal Bello, F, Romano, N, Mancuso, S, Calzetti, C, Maserati, R, Filice, G, Baldanti, F, Francisci, D, Parruti, G, Polilli, E, Sacchini, D, Martinelli, C, Consolini, R, Vatteroni, L, Vivarelli, A, Dionisio, D, Nerli, A, Lenzi, L, Magnani, G, Ortolani, P, Andreoni, M, Palamara, G, Fimiani, C, Palmisano, L, Vullo, Vincenzo, Turriziani, O, Montano, M, Cenderello, G, Gonnelli, A, Palumbo, M, Delle Foglie, P, Rossi, C, Poletti, F, Mondino, V, Malena, M, and Lattuada, E.

Published
2010

19. Longitudinal analysis of HIV-1 coreceptor tropism by single and triplicate HIV-1 RNA and DNA sequencing in patients undergoing successful first-line antiretroviral therapy

Author

Meini, G, Rossetti, B, Bianco, C, Ceccherini Silberstein, F, Di Giambenedetto, S, Sighinolfi, L, Monno, L, Castagna, A, Rozera, G, D'arminio Monforte, A, Zazzi, M, De Luca, A, Moroni, M, Armignacco, O, Iardino, R, Ippolito, G, Perno, C, Von Schloesser, F, Cozzi Lepri, A, Girardi, E, Balotta, C, Borderi, M, Capobianchi, M, Cinque, P, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Marcotullio, S, Rusconi, S, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantini, A, Angarano, G, Santoro, C, Maggiolo, F, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Castelli, F, Quiros Roldan, E, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Segala, D, Mazzotta, F, Lo Caputo, S, Cassola, G, Viscoli, G, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Bonfanti, P, Caramma, I, Castelli, A, Galli, M, Lazzarin, A, Rizzardini, G, Puoti, M, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Cicconi, P, Marchetti, G, Mussini, C, Puzzolante, C, Gori, A, Lapadula, G, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Cauda, R, Andreoni, M, Antinori, A, Vullo, V, Cingolani, A, D'Avino, A, Ammassari, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Mura, M, Madeddu, G, Caramello, P, Di Perri, G, Orofino, G, Bonora, S, Sciandra, M, Pellizzer, G, Manfrin, V, Manfrin, V., GORI, ANDREA, Meini, G, Rossetti, B, Bianco, C, Ceccherini Silberstein, F, Di Giambenedetto, S, Sighinolfi, L, Monno, L, Castagna, A, Rozera, G, D'arminio Monforte, A, Zazzi, M, De Luca, A, Moroni, M, Armignacco, O, Iardino, R, Ippolito, G, Perno, C, Von Schloesser, F, Cozzi Lepri, A, Girardi, E, Balotta, C, Borderi, M, Capobianchi, M, Cinque, P, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Marcotullio, S, Rusconi, S, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantini, A, Angarano, G, Santoro, C, Maggiolo, F, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Castelli, F, Quiros Roldan, E, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Segala, D, Mazzotta, F, Lo Caputo, S, Cassola, G, Viscoli, G, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Bonfanti, P, Caramma, I, Castelli, A, Galli, M, Lazzarin, A, Rizzardini, G, Puoti, M, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Cicconi, P, Marchetti, G, Mussini, C, Puzzolante, C, Gori, A, Lapadula, G, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Cauda, R, Andreoni, M, Antinori, A, Vullo, V, Cingolani, A, D'Avino, A, Ammassari, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Mura, M, Madeddu, G, Caramello, P, Di Perri, G, Orofino, G, Bonora, S, Sciandra, M, Pellizzer, G, Manfrin, V, Manfrin, V., and GORI, ANDREA

Abstract

Objectives: Maraviroc has been shown to be effective in patients harbouring CCR5-tropic HIV-1. While this CCR5 antagonist has initially been used in salvage therapy, its excellent safety profile makes it ideal for antiretroviral treatment simplification strategies in patients with suppressed plasma viraemia. The aim of this study was to compare HIV-1 tropism as detected in baseline plasma RNA and peripheral blood mononuclear cell (PBMC) DNA prior to first-line therapy and to analyse tropism evolution while on successful treatment. Methods: HIV-1 tropism was determined using triplicate genotypic testing combined with geno2pheno[coreceptor] analysis at a 10% false positive rate in 42 patients. Paired pre-treatment plasma RNA and PBMC DNA and two subsequent PBMC DNA samples (the first obtained after reaching undetectable plasma HIV-1 RNA and the second after at least 2 years of suppression of plasma viraemia) were evaluated. Results: Coreceptor tropism was completely concordant in paired pre-treatment RNA and DNA, with 26.2% of HIV-1 sequences predicted to be non-CCR5-tropic. During follow-up, coreceptor tropism switches were detected in 4 (9.5%) patients without any preferential direction. Although false positive rate discrepancies within triplicates were common, the rate of discordance of coreceptor tropism assignment among triplicate results in this mostly CCR5-tropic dataset was only 2.1%, questioning the added value of triplicate testing compared with single testing. Conclusions: HIV-1 coreceptor tropism changes during virologically successful first-line treatment are infrequent. HIV-1 DNA analysis may thus support the choice of a CCR5 antagonist in treatment switch strategies; however, maraviroc treatment outcome data are required to confirm this option. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved

Published
2014

20. Switch to raltegravir-based regimens and HIV DNA decrease in patients with suppressed HIV RNA

Author

Bianco, Claudia, Meini, G, Rossetti, Barbara, Lamonica, S, Mondi, Annalisa, Belmonti, S, Fanti, L, Ciccarelli, Nicoletta, Di Giambenedetto, Simona, Zazzi, M, De Luca, Andrea, Ciccarelli, Nicoletta (ORCID:0000-0002-7582-9142), Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Luca, Andrea (ORCID:0000-0002-8311-6935), Bianco, Claudia, Meini, G, Rossetti, Barbara, Lamonica, S, Mondi, Annalisa, Belmonti, S, Fanti, L, Ciccarelli, Nicoletta, Di Giambenedetto, Simona, Zazzi, M, De Luca, Andrea, Ciccarelli, Nicoletta (ORCID:0000-0002-7582-9142), Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

Raltegravir intensification is associated with an increase in 2-LTR episomal HIV DNA= circles, indicating a persistent low-level replication, in some individuals in ART with suppressed HIV RNA. We aimed at monitoring residual plasma HIV RNA and cellular HIV DNA in virologically suppressed patients switching to a raltegravir-based regimen.

Published
2014

21. Genotypic testing on HIV-1 DNA as a tool to assess HIV-1 co-receptor usage in clinical practice: results from the DIVA study group

Author

Svicher, V, Alteri, C, Montano, M, Nori, A, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Barresi, R, Calderisi, S, Callegaro, Ap, Capobianchi, Mr, Gargiulo, F, Castelli, F, Cauda, Roberto, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, Manuela, D'Arminio Monforte, A, De Luca, Andrea, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Santo, F, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Costantini, A, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Nozza, S, Paolucci, S, Palù, G, Parisi, S, Parruti, G, Pignataro, Ar, Quirino, T, Re, Mc, Rizzardini, G, Sanguinetti, Maurizio, Santangelo, Rosaria, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, Ml, Viscoli, C, Vullo, V, Zazzi, M, Lazzarin, A, Perno, Cf, Cauda, Roberto (ORCID:0000-0002-1498-4229), De Luca, Andrea (ORCID:0000-0002-8311-6935), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Santangelo, Rosaria (ORCID:0000-0002-8056-218X), Svicher, V, Alteri, C, Montano, M, Nori, A, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Barresi, R, Calderisi, S, Callegaro, Ap, Capobianchi, Mr, Gargiulo, F, Castelli, F, Cauda, Roberto, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, Manuela, D'Arminio Monforte, A, De Luca, Andrea, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Santo, F, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Costantini, A, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Nozza, S, Paolucci, S, Palù, G, Parisi, S, Parruti, G, Pignataro, Ar, Quirino, T, Re, Mc, Rizzardini, G, Sanguinetti, Maurizio, Santangelo, Rosaria, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, Ml, Viscoli, C, Vullo, V, Zazzi, M, Lazzarin, A, Perno, Cf, Cauda, Roberto (ORCID:0000-0002-1498-4229), De Luca, Andrea (ORCID:0000-0002-8311-6935), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), and Santangelo, Rosaria (ORCID:0000-0002-8056-218X)

Abstract

We have developed a sequencing assay for determining the usage of the genotypic HIV-1 co-receptor using peripheral blood mononuclear cell (PBMC) DNA in virologically suppressed HIV-1 infected patients. Our specific aims were to (1) evaluate the efficiency of V3 sequences in B versus non-B subtypes, (2) compare the efficiency of V3 sequences and tropism prediction using whole blood and PBMCs for DNA extraction, (3) compare the efficiency of V3 sequences and tropism prediction using a single versus a triplicate round of amplification.

Published
2014

24. Longitudinal analysis of HIV-1 coreceptor tropism by single and triplicate HIV-1 RNA and DNA sequencing in patients undergoing successful first-line antiretroviral therapy

Author

Meini, G, Rossetti, B, Bianco, C, Ceccherini Silberstein, F, Di Giambenedetto, Simona, Sighinolfi, L, Monno, L, Castagna, A, Rozera, G, D'Arminio Monforte, A, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Luca, Andrea (ORCID:0000-0002-8311-6935), Meini, G, Rossetti, B, Bianco, C, Ceccherini Silberstein, F, Di Giambenedetto, Simona, Sighinolfi, L, Monno, L, Castagna, A, Rozera, G, D'Arminio Monforte, A, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

Maraviroc has been shown to be effective in patients harbouring CCR5-tropic HIV-1. While this CCR5 antagonist has initially been used in salvage therapy, its excellent safety profile makes it ideal for antiretroviral treatment simplification strategies in patients with suppressed plasma viraemia. The aim of this study was to compare HIV-1 tropism as detected in baseline plasma RNA and peripheral blood mononuclear cell (PBMC) DNA prior to first-line therapy and to analyse tropism evolution while on successful treatment.

Published
2013

25. Performance of genotypic tropism testing on proviral DNA in clinical practice: results from the DIVA study group

Author

Svicher, V, Alteri, C, Montano, M, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Callegaro, A, Capobianchi, M, Carosi, G, Cauda, R, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, M, D'Arminio Monforte, A, De Luca, A, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Pietro, M, Di Santo, F, Fabeni, L, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, C, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Manca, G, Gargiulo, F, Martinelli, C, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Narciso, P, Nozza, S, Paolucci, S, Pal, G, Parisi, S, Parruti, G, Pignataro, A, Pollicita, M, Quirino, T, Re, M, Rizzardini, G, Santangelo, R, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, M, Vecchi, L, Viscoli, C, Vullo, V, Zazzi, M, Lazzarini, A, Perno, C, GORI, ANDREA, Perno, C., Svicher, V, Alteri, C, Montano, M, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Callegaro, A, Capobianchi, M, Carosi, G, Cauda, R, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, M, D'Arminio Monforte, A, De Luca, A, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Pietro, M, Di Santo, F, Fabeni, L, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, C, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Manca, G, Gargiulo, F, Martinelli, C, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Narciso, P, Nozza, S, Paolucci, S, Pal, G, Parisi, S, Parruti, G, Pignataro, A, Pollicita, M, Quirino, T, Re, M, Rizzardini, G, Santangelo, R, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, M, Vecchi, L, Viscoli, C, Vullo, V, Zazzi, M, Lazzarini, A, Perno, C, GORI, ANDREA, and Perno, C.

Abstract

The DIVA study is aimed at setting up a standardized genotypic tropism-testing on proviral-DNA for the routine clinical diagnostic-laboratory. Methods: Twelve local centres and 5 reference centres (previously cross-validated) were identified. For inter-center validation-procedure, 60 peripheral-blood mononuclear cells (PBMCs) aliquots from 45 HAART-treated patients were randomly chosen for population V3 sequencing on proviral-DNA at local HIV centre and at reference-laboratory. Viral tropism was predicted by Geno2Pheno algorithm (False Positive Rate [FPR] = 20%) as proposed by the European-Guidelines. Quantification of total HIV-1 DNA was based on a method described by Viard (2004). Results: Quantification of HIV-1 DNA was available for 35/45 (77.8%) samples, and gave a median value of 598 (IQR:252- 1,203) copies/10 6 PBMCs. A total of 56/60 (93.3%) samples were successfully amplified by both the reference and the local virological centers. The overall concordance of tropism prediction between local and reference centers was 54/56 (96.4%). Results of tropism prediction by local centers were: 33/54 (61.1%) R5 and 21/54 (38.9%) X4/DM. Conclusion: There was high concordance in the genotypic tropism prediction based on proviral DNA among different virological centers throughout Italy. Our results are in line with other European studies, and support the use of genotypic tropism testing on proviral DNA in patients with suppressed plasma HIV-1 RNA candidate to CCR5-antagonist treatment.

Published
2012

26. Prevalence of HIV-1 integrase mutations related to resistance to dolutegravir in raltegravir naïve and pretreated patients

Author

Saladini, F, Meini, G, Bianco, C, Monno, L, Punzi, G, Pecorari, M, Borghi, V, Di Pietro, M, Filice, G, Gismondo, Mr, Micheli, V, Penco, G, Carli, T, De Luca, Andrea, Zazzi, M., De Luca, Andrea (ORCID:0000-0002-8311-6935), Saladini, F, Meini, G, Bianco, C, Monno, L, Punzi, G, Pecorari, M, Borghi, V, Di Pietro, M, Filice, G, Gismondo, Mr, Micheli, V, Penco, G, Carli, T, De Luca, Andrea, Zazzi, M., and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

The prevalence of HIV-1 integrase mutations related to resistance to the next-generation integrase inhibitor (INI), dolutegravir (DTG), was assessed in 440 INI-naïve subjects and in 120 patients failing a raltegravir (RTG)-containing regimen. Of the mutations selected by DTG in vitro, S153FY was not detected in any isolate while L101I and T124A were highly prevalent in both groups and significantly associated with non-B subtype. RTG-selected double and triple mutants, mostly the G140S/Q148H variant, were detected in only 32 (26.7%) RTG-treated patients. As L101I and T124A do not appear to exert any major effect in vivo and double and triple mutants resistant to DTG are infrequently selected by RTG, DTG can be effectively used in INI-naïve patients and may retain activity in many patients failing RTG.

Published
2012

27. Naturally occurring hepatitis C virus (HCV) NS3/4A protease inhibitor resistance-related mutations in HCV genotype 1-infected subjects in Italy

Author

Vicenti, I, Rosi, A, Saladini, F, Meini, G, Pippi, F, Rossetti, B, Sidella, Letizia, Di Giambenedetto, Simona, Almi, P, De Luca, Andrea, Caudai, C, Zazzi, M., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Luca, Andrea (ORCID:0000-0002-8311-6935), Vicenti, I, Rosi, A, Saladini, F, Meini, G, Pippi, F, Rossetti, B, Sidella, Letizia, Di Giambenedetto, Simona, Almi, P, De Luca, Andrea, Caudai, C, Zazzi, M., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

To assess the prevalence of hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) resistance mutations in HCV genotype 1-infected PI-naive individuals in Italy.

Published
2012

29. A prognostic model for estimating the time to virologic failure in HIV-1 infected patients undergoing a new combination antiretroviral therapy regimen

Author

Prosperi, Mcf, Di Giambenedetto, Simona, Fanti, Iuri, Meini, G, Bruzzone, B, Callegaro, A, Penco, G, Bagnarelli, P, Micheli, V, Paolini, E, Di Biagio, A, Ghisetti, V, Di Pietro, Maria Luisa, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Di Pietro, Maria Luisa (ORCID:0000-0002-3893-8788), De Luca, Andrea (ORCID:0000-0002-8311-6935), Prosperi, Mcf, Di Giambenedetto, Simona, Fanti, Iuri, Meini, G, Bruzzone, B, Callegaro, A, Penco, G, Bagnarelli, P, Micheli, V, Paolini, E, Di Biagio, A, Ghisetti, V, Di Pietro, Maria Luisa, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Di Pietro, Maria Luisa (ORCID:0000-0002-3893-8788), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

HIV-1 genotypic susceptibility scores (GSSs) were proven to be significant prognostic factors of fixed time-point virologic outcomes after combination antiretroviral therapy (cART) switch/initiation. However, their relative-hazard for the time to virologic failure has not been thoroughly investigated, and an expert system that is able to predict how long a new cART regimen will remain effective has never been designed.

Published
2011

30. Update on emergence of HIV-1 resistance to antiretroviral drug classes in an Italian national database: 2007-2009

Author

Di Giambenedetto, Simona, Prosperi, M, Fanti, Iuri, Bruzzone, B, Paolucci, Sabrina, Penco, G, Meini, G, Di Biagio, A, Paolini, E, Micheli, V, Meraviglia, P, Castelli, P, Corsi, Paola, Gonnelli, A, Fabbiani, Massimiliano, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), De Luca, Andrea (ORCID:0000-0002-8311-6935), Di Giambenedetto, Simona, Prosperi, M, Fanti, Iuri, Bruzzone, B, Paolucci, Sabrina, Penco, G, Meini, G, Di Biagio, A, Paolini, E, Micheli, V, Meraviglia, P, Castelli, P, Corsi, Paola, Gonnelli, A, Fabbiani, Massimiliano, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

We analysed trends of human immunodeficiency virus type 1 (HIV-1) drug resistance during 2007-2009 in the Italian national HIV drug resistance database 'ARCA'. Prevalence of resistance in each year was examined on the basis of the presence of major International AIDS Society-2009 mutations. Predictors of resistance were analysed by multivariable logistic regression. Nine hundred and sixty-six patients were selected. Resistance to nucleoside reverse transcriptase inhibitors and protease inhibitors showed a significant decline with respect to previous surveys. Resistance to any class of drug and three drug classes remained stable. Independent predictors of three-class resistance were the number of treatment regimens experienced, prior suboptimal nucleoside reverse transcriptase inhibitor therapy and the current use of ritonavir-boosted protease inhibitors.

Published
2011

31. Comparative determination of HIV-1 co-receptor tropism by Enhanced Sensitivity Trofile, gp120 V3-loop RNA and DNA genotyping

Author

Prosperi, Mc, Bracciale, Laura, Fabbiani, Massimiliano, Di Giambenedetto, Simona, Razzolini, F, Meini, G, Colafigli, Manuela, Marzocchetti, Angela, Cauda, Roberto, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Cauda, Roberto (ORCID:0000-0002-1498-4229), De Luca, Andrea (ORCID:0000-0002-8311-6935), Prosperi, Mc, Bracciale, Laura, Fabbiani, Massimiliano, Di Giambenedetto, Simona, Razzolini, F, Meini, G, Colafigli, Manuela, Marzocchetti, Angela, Cauda, Roberto, Zazzi, M, De Luca, Andrea, Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Cauda, Roberto (ORCID:0000-0002-1498-4229), and De Luca, Andrea (ORCID:0000-0002-8311-6935)

Abstract

BACKGROUND: Trofile is the prospectively validated HIV-1 tropism assay. Its use is limited by high costs, long turn-around time, and inability to test patients with very low or undetectable viremia. We aimed at assessing the efficiency of population genotypic assays based on gp120 V3-loop sequencing for the determination of tropism in plasma viral RNA and in whole-blood viral DNA. Contemporary and follow-up plasma and whole-blood samples from patients undergoing tropism testing via the enhanced sensitivity Trofile (ESTA) were collected. Clinical and clonal geno2pheno[coreceptor] (G2P) models at 10% and at optimised 5.7% false positive rate cutoff were evaluated using viral DNA and RNA samples, compared against each other and ESTA, using Cohen's kappa, phylogenetic analysis, and area under the receiver operating characteristic (AUROC). RESULTS: Both clinical and clonal G2P (with different false positive rates) showed good performances in predicting the ESTA outcome (for V3 RNA-based clinical G2P at 10% false positive rate AUROC = 0.83, sensitivity = 90%, specificity = 75%). The rate of agreement between DNA- and RNA-based clinical G2P was fair (kappa = 0.74, p < 0.0001), and DNA-based clinical G2P accurately predicted the plasma ESTA (AUROC = 0.86). Significant differences in the viral populations were detected when comparing inter/intra patient diversity of viral DNA with RNA sequences. CONCLUSIONS: Plasma HIV RNA or whole-blood HIV DNA V3-loop sequencing interpreted with clinical G2P is cheap and can be a good surrogate for ESTA. Although there may be differences among viral RNA and DNA populations in the same host, DNA-based G2P may be used as an indication of viral tropism in patients with undetectable plasma viremia.

Published
2010

32. Performance of genotypic tropism testing in clinical practice using the enhanced sensitivity version of Trofile as reference assay: results from the OSCAR Study Group

Author

Svicher, V, D'Arrigo, R, Alteri, C, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bonn, I, Bruzzone, B, Callegaro, Ap, Cammarota, R, Canducci, F, Ceccherini Silberstein, F, Clementi, M, Monforte, Ad, De Luca, Andrea, Di Biagio, A, Di Giambenedetto, Simona, Di Perri, G, Di Pietro, M, Fabeni, L, Fadda, Giovanni, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, A, Leoncini, F, Maggiolo, F, Maserati, R, Mazzotta, F, Micheli, V, Meini, G, Monno, L, Mussini, C, Nozza, S, Paolucci, S, Parisi, S, Pecorari, M, Pizzi, D, Quirino, T, Re, Mc, Rizzardini, G, Santangelo, Rosaria, Soria, A, Stazi, F, Sterrantino, G, Turriziani, O, Viscoli, C, Vullo, V, Lazzarin, A, Perno, Cf, Oscar, Study Group, De Luca, Andrea (ORCID:0000-0002-8311-6935), Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Santangelo, Rosaria (ORCID:0000-0002-8056-218X), Svicher, V, D'Arrigo, R, Alteri, C, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bonn, I, Bruzzone, B, Callegaro, Ap, Cammarota, R, Canducci, F, Ceccherini Silberstein, F, Clementi, M, Monforte, Ad, De Luca, Andrea, Di Biagio, A, Di Giambenedetto, Simona, Di Perri, G, Di Pietro, M, Fabeni, L, Fadda, Giovanni, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, A, Leoncini, F, Maggiolo, F, Maserati, R, Mazzotta, F, Micheli, V, Meini, G, Monno, L, Mussini, C, Nozza, S, Paolucci, S, Parisi, S, Pecorari, M, Pizzi, D, Quirino, T, Re, Mc, Rizzardini, G, Santangelo, Rosaria, Soria, A, Stazi, F, Sterrantino, G, Turriziani, O, Viscoli, C, Vullo, V, Lazzarin, A, Perno, Cf, Oscar, Study Group, De Luca, Andrea (ORCID:0000-0002-8311-6935), Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and Santangelo, Rosaria (ORCID:0000-0002-8056-218X)

Published
2010

33. Genotypic testing on HIV-1 DNA as a tool to assess HIV-1 co-receptor usage in clinical practice: results from the DIVA study group

Author

Svicher, V., primary, Alteri, C., additional, Montano, M., additional, Nori, A., additional, D’Arrigo, R., additional, Andreoni, M., additional, Angarano, G., additional, Antinori, A., additional, Antonelli, G., additional, Allice, T., additional, Bagnarelli, P., additional, Baldanti, F., additional, Bertoli, A., additional, Borderi, M., additional, Boeri, E., additional, Bon, I., additional, Bruzzone, B., additional, Barresi, R., additional, Calderisi, S., additional, Callegaro, A. P., additional, Capobianchi, M. R., additional, Gargiulo, F., additional, Castelli, F., additional, Cauda, R., additional, Ceccherini-Silberstein, F., additional, Clementi, M., additional, Chirianni, A., additional, Colafigli, M., additional, D’Arminio Monforte, A., additional, De Luca, A., additional, Di Biagio, A., additional, Di Nicuolo, G., additional, Di Perri, G., additional, Di Santo, F., additional, Fadda, G., additional, Galli, M., additional, Gennari, W., additional, Ghisetti, V., additional, Costantini, A., additional, Gori, A., additional, Gulminetti, R., additional, Leoncini, F., additional, Maffongelli, G., additional, Maggiolo, F., additional, Maserati, R., additional, Mazzotta, F., additional, Meini, G., additional, Micheli, V., additional, Monno, L., additional, Mussini, C., additional, Nozza, S., additional, Paolucci, S., additional, Palù, G., additional, Parisi, S., additional, Parruti, G., additional, Pignataro, A. R., additional, Quirino, T., additional, Re, M. C., additional, Rizzardini, G., additional, Sanguinetti, M., additional, Santangelo, R., additional, Scaggiante, R., additional, Sterrantino, G., additional, Turriziani, O., additional, Vatteroni, M. L., additional, Viscoli, C., additional, Vullo, V., additional, Zazzi, M., additional, Lazzarin, A., additional, and Perno, C. F., additional

Published
2013
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38. A new species of otoplanid (Plathelminthes: Rhabditophora: Otoplanidae) from Sicily, Italy.

Author

Lanfranchi, A., Meini, G., and Melai, M.

Abstract

A new species, Philosyrtis aegusae sp. nov., collected in the ‘Otoplanen-Zone’ of the sands of western Sicily, is described. The specimens show the typical morphological peculiarities of the subfamily Parotoplaninae (‘Turbellaria’: Otoplanidae), but differ clearly from the species already described. The body length of the sexually mature animals reaches 0.9–1.1 mm and they appear to belong to the genus Philosyrtis because of the general arrangement of testes and germo-vitellaria, and of the sclerotic apparatus. The vesicula granulorum is clearly distinct from the sclerotic apparatus unlike the other ten species belonging to the same genus. The male copulatory organ consists of a dorsal group of 7–8 spines similar in shape and length (33–40 mm), and a ventral group of at least 6 long thin spines with curved pointed tips. The new species differs from the already described species above all in its body dimensions, the shorter path of the vitellaries and especially the characteristics of the male sclerotic apparatus. [ABSTRACT FROM PUBLISHER]

Published
2011
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39. Postbursoplana parafibulata sp. nov.: A new flatworm from the Ligurian Sea (Plathelminthes, Rhabditophora, Otoplanidae).

Author

LANFRANCHI, A., MELAI, M., and MEINI, G.

Subjects
PLATYHELMINTHES, MARINE worms, WORMS
Abstract

A new species, Postbursoplana parafibulata sp. nov., is described from lower interstitial habitats of the Upper Tuscan sea coast (Ligurian Sea). The specimens display the typical collar-shaped pharynx, perpendicularly positioned, of the subfamily Parotoplaninae (“Turbellaria”, Otoplanidae). The sexually mature animals are 1.2-1.4 mm in length, and appear to belong to the genus Postbursoplana because of the general arrangement of testes and germo-vitellaria, and of the sclerotic apparatus characteristics. Their male copulatory organ consists of 10 spines differentiated in five groups with variable shape and length (52-73 μm). P. parafibulata sp. nov. differs from the already described species above all for the body dimensions and the characteristics of the sclerotic male apparatus. The new species appears more similar to P. fibulata collected in the Mediterranean Sea. [ABSTRACT FROM AUTHOR]

Published
2010
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40. Performance of genotypic tropism testing in clinical practice using the enhanced sensitivity version of Trofile as reference assay: Results from the OSCAR Study Group

Author

Svicher V, D'Arrigo R, Alteri C, Andreoni M, Angarano G, Antinori A, Antonelli G, Bagnarelli P, Baldanti F, Bertoli A, Boeri E, Bruzzone B, Callegaro AP, Cammarota R, Canducci F, Ceccherini Silberstein F, Clementi M, Monforte AD, De Luca A, Di Biagio A, Di Gianbenedetto S, Di Perri G, Di Pietro M, Fabeni L, Fadda G, Galli M, Gennari W, Ghisetti V, Giacometti A, Gori A, Leoncini F, Maggiolo F, Maserati R, Mazzotta F, Micheli V, Meini G, Monno L, Mussini C, Nozza S, Paolucci S, Parisi S, Pecorari M, Pizzi D, Quirino T, Rizzardini G, Santangelo R, Soria A, Stazi F, Sterrantino G, Turriziani O, Viscoli C, Vullo V, Lazzarin A, Perno CF, OSCAR Study Group, BORDERI, MARCO, BON, ISABELLA, RE, MARIA CARLA, Svicher V, D'Arrigo R, Alteri C, Andreoni M, Angarano G, Antinori A, Antonelli G, Bagnarelli P, Baldanti F, Bertoli A, Borderi M, Boeri E, Bonn I, Bruzzone B, Callegaro AP, Cammarota R, Canducci F, Ceccherini-Silberstein F, Clementi M, Monforte AD, De Luca A, Di Biagio A, Di Gianbenedetto S, Di Perri G, Di Pietro M, Fabeni L, Fadda G, Galli M, Gennari W, Ghisetti V, Giacometti A, Gori A, Leoncini F, Maggiolo F, Maserati R, Mazzotta F, Micheli V, Meini G, Monno L, Mussini C, Nozza S, Paolucci S, Parisi S, Pecorari M, Pizzi D, Quirino T, Re MC, Rizzardini G, Santangelo R, Soria A, Stazi F, Sterrantino G, Turriziani O, Viscoli C, Vullo V, Lazzarin A, Perno CF, and OSCAR Study Group.

Subjects
Male, Protein Structure, trafile, Receptors, CCR5, Genotype, Settore MED/17 - Malattie Infettive, HIV, viral load, AIDS, hiv, HIV Infections, HIV Envelope Protein gp120, v3 loop, Receptors, Humans, Viral Tropism, Protein Structure, Tertiary, HIV-1, Female, Receptors, Virus, tropism, virus diseases, genotypic tropism testing, OSCAR Study Group, Settore MED/07 - Microbiologia e Microbiologia Clinica, Virus, genotypic tropism, CCR5 Receptor Antagonists, CCR5, Tertiary
Abstract

Objective: The goal of the OSCAR programme is to evaluate the performances of genotypic HIV-1 tropism testing in clinical practice using the enhanced sensitivity version of Trafile (ESTA) as reference-assay. Methods: HIV-1 coreceptor-usage was assessed using plasma samples from 406 HIV-1 infected patients by ESTA and by gp120 V3 population-sequencing followed by Geno2pheno (set at a False Positive Rate [FPR] of 10% and 5%). Results: ESTA was successful in 365 (89.9%) samples indicating R5 in 254 (69.6%), and DM/X4 in 111 (30.4% of samples (104 [28.5%] DM and 7 [1.9%] X4). Genotypic-testing successfully assessed viral tropism for all 406 samples, including the 41 with undetermined result by ESTA. Genotypic-tropism testing at a FPR of 5% and 10% was 81.1% and 78.4% concordant with ESTA, respectively. Despite a sensitivity of 48.7% and 55.9% at a FPR of 5% and 10%, respectively, a high concordance (specificity: 95.3% for FPR of 5% and 88.2% for FPR of 10%) between genotypic-tropism testing and ESTA was reached in the detection of R5-tropic viruses. Conclusion: Our results are in line with other European studies, and support the routine use of genotypic tropism testing in clinical-settings for monitoring of HIV-1 infected patients candidate to or failing CCR5-antagonists.

42. PREVALENCE OF ETRAVIRINE (ETR)-RESISTANCE ASSOCIATED MUTATIONS AT NNRTI FAILURE AND PREDICTORS OF RESISTANCE TO ETR IN A LARGE ITALIAN RESISTANCE DATABASE (ARCA)

Author

Rusconi, S., Adorni, F., Bruzzone, B., Antonio Di Biagio, Meini, G., Callegaro, A., Punzi, G., Boeri, E., Pecorari, M., Monno, L., Gianotti, N., Butini, L., Galli, L., Polilli, E., and Galli, M.

Subjects
Drug resistance, HIV, Etravirine
Abstract

Background: Etravirine (TMC125, ETR) is the newest nonnucleoside reverse transcriptase inhibitor (NNRTI) designed to be active against both wild-type and NNRTI-resistant HIV. Three algorithms have been developed to interpret ETR resistance: Monogram (MGR), Tibotec (TBT), and enhanced MGR (ENH). We investigated the prevalence of drug resistance mutations associated to NNRTI-based regimens failure and the predictors of resistance to ETR among subjects included in a large Italian resistance database. Material and methods: From the Italian database ARCA ( http://www.hivarca.net), we selected 5,547 sequences from 3,047 subjects up to 29 December 2010. Among these individuals, 39 had\18 (P) years and 2,815 were C18 (A) years-old. These subjects failed their current NNRTI treatment, were three-class experienced and had been exposed toNNRTIC3 months. Complete treatment history,HIV-1 RNA [1,000 cp/mL at failure, CD4 counts within 30 days before the genotypic resistance test were available. Binomial logistic regression analysis was carried out and odds ratio (AORorOR[CI 95%])were expressed.All data were adjusted for CD4 counts and HIV-1 RNA levels. Results: 1,827 A subjects (64.9%) and 32 P subjects (82.1%) harboured virus with at least one ETR mutation included in at least one score. Among the A subjects with at least one ETR mutation, mutations more frequently detected were Y181C (18.5%), G190A (15.1%), and V179I (11.2%). Among P subjects, V179I, Y181C, and G190A were present in 30.8, 28.2 and 23.1%, respectively. Univariate analysis revealed an increased risk in the pediatric population (vs. adult population) for exceeding cut-off values of ETR resistance with all three algorithms: MGR[3 OR 2.10 (1.11-3.94) p = .022, TBT[2 OR 2.56 (1.36-4.82) p = .004, and ENH C4 OR 2.44 (1.28-4.64) p = .007. Multivariate analysis revealed an increased risk of developing TBT[2 for NNRTI exposure, ENH C4 for NNRTI and EFV exposure in P subjects; NVP exposure and higher (C3.5 log10) HIV-RNA values for all three algorithms in A subjects, whereas CD4 C200/lL appeared to be protective. Conclusions: The DUET studies showed that C3 ETR-associated mutations were required to impair the efficacy of the drug and Y181C/V, V179F and G190S had the most pronounced effect on response. The prevalence of Y181C mutation was higher in P versus A subjects (28.2 vs. 18.5%) together with G190A and V179I. The risk to be ETR resistant, according to all algorithms, was more than double for P versus A subjects, probably due to a more extensive use of NNRTI and an incomplete virological control. Determinants of genotypic resistance to ETR were higher HIV-1 RNA values and greater NVP exposure in A subjects; a detrimental effect of NNRTI and EFV exposure was shown in P subjects. Higher levels of immune competence were protective for future development of ETR genotypic resistance.

43. Performance of genotypic tropism testing on proviral DNA in clinical practice: Results from the DIVA study group

Author

Svicher, Valentina, Alteri, Claudia, Montano, Marco, D Arrigo, Roberta, Andreoni, Massimo, Angarano, Gioacchino, Antinori, Andrea, Antonelli, Guido, Allice, Tiziano, Bagnarelli, Patrizia, Baldanti, Fausto, Bertoli, Ada, Borderi, Marco, Boeri, Enzo, Bon, Isabella, Bruzzone, Bianca, Callegaro, Anna Paola, Capobianchi, Maria Rosaria, Carosi, Giampiero, Cauda, Roberto, Ceccherini-Silberstein, Francesca, Clementi, Massimo, Chirianni, Antonio, Manuela Colafigli, Monforte, Antonella D. Arminio, Luca, Andrea, Di Biagio, Antonio, Di Nicuolo, Giuseppe, Di Perri, Giovanni, Di Pietro, Massimo, Di Santo, Fabiola, Fabeni, Lavinia, Fadda, Giovanni, Galli, Massimo, Gennari, William, Ghisetti, Valeria, Giacometti, Andrea, Gori, Caterina, Gori, Andrea, Gulminetti, Roberto, Leoncini, Francesco, Maffongelli, Gaetano, Maggiolo, Franco, Manca, Giuseppe, Gargiulo, Franco, Martinelli, Canio, Maserati, Renato, Mazzotta, Francesco, Meini, Genny, Micheli, Valeria, Monno, Laura, Mussini, Cristina, Narciso, Pasquale, Nozza, Silvia, Paolucci, Stefania, Palu, Giorgio, Parisi, Saverio, Parruti, Giustino, Pignataro, Angela Rosa, Pollicita, Michela, Quirino, Tiziana, Re, Maria Carla, Rizzardini, Giuliano, Santangelo, Rosaria, Scaggiante, Renzo, Sterrantino, Gaetana, Turriziani, Ombretta, Vatteroni, Maria Linda, Vecchi, Laura, Viscoli, Claudio, Vullo, Vincenzo, Zazzi, Maurizio, Lazzarin, Adriano, Perno, Carlo Federico, Diva, Grp, Svicher V, Alteri C, Montano M, D'Arrigo R, Andreoni M, Angarano G, Antinori A, Antonelli G, Allice T, Bagnarelli P, Baldanti F, Bertoli A, Borderi M, Boeri E, Bon I, Bruzzone B, Callegaro AP, Capobianchi MR, Carosi G, Cauda R, Ceccherini-Silberstein F, Clementi M, Chirianni A, Colafigli M, D'Arminio Monforte A, De Luca A, Di Biagio A, Di Nicuolo G, Di Perri G, Di Pietro M, Di Santo F, Fabeni L, Fadda G, Galli M, Gennari W, Ghisetti V, Giacometti A, Gori C, Gori A, Gulminetti R, Leoncini F, Maffongelli G, Maggiolo F, Manca G, Gargiulo F, Martinelli C, Maserati R, Mazzotta F, Meini G, Micheli V, Monno L, Mussini C, Narciso P, Nozza S, Paolucci S, Pal G, Parisi S, Parruti G, Pignataro AR, Pollicita M, Quirino T, Re MC, Rizzardini G, Santangelo R, Scaggiante R, Sterrantino G, Turriziani O, Vatteroni ML, Vecchi L, Viscoli C, Vullo V, Zazzi M, Lazzarini A, Perno CF., Svicher, V, Alteri, C, Montano, M, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Callegaro, Ap, Capobianchi, Mr, Carosi, G, Cauda, R, Ceccherini Silberstein, F, Clementi, Massimo, Chirianni, A, Colafigli, M, Monforte, Ad, De Luca, A, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Pietro, M, Di Santo, F, Fabeni, L, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, C, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Manca, G, Gargiulo, F, Martinelli, C, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Narciso, P, Nozza, S, Paolucci, S, Palu, G, Parisi, S, Parruti, G, Pignataro, Ar, Pollicita, M, Quirino, T, Re, Mc, Rizzardini, G, Santangelo, R, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, Ml, Vecchi, L, Viscoli, C, Vullo, V, Zazzi, M, Lazzarin, Adriano, Perno, Cf, Callegaro, A, Capobianchi, M, Clementi, M, D'Arminio Monforte, A, Pal, G, Pignataro, A, Re, M, Vatteroni, M, Lazzarini, A, and Perno, C

Subjects
Male, Genotype, Genotyping Techniques, IMPACT, Mononuclear, HIV-1 TROPISM, Proviral DNA, Reproducibility of Result, HIV Infections, CORECEPTOR SWITCH, HIV Envelope Protein gp120, FREQUENCY, Tropism, CXCR4-USING HIV, HIV, AIDS, DNA provirale, ANTIRETROVIRAL THERAPY, Proviruses, INFECTION, Leukocytes, Humans, HIV Infection, CD4 CELL COUNT, PLASMA RNA, MARAVIROC, Proviruse, hiv, tropism, proviral dna, virus diseases, Reproducibility of Results, Viral Load, Settore MED/07 - Microbiologia e Microbiologia Clinica, Viral Tropism, HIV-1, Leukocytes, Mononuclear, Female, Genotyping Technique, Human
Abstract

"Objective: The DIVA study is aimed at setting up a standardized genotypic tropism-testing on proviral-DNA for the routine clinical diagnostic-laboratory Methods: Twelve local centres and 5 reference centres (previously cross-validated) were identified. For inter-center validation-procedure, 60 peripheral-blood mononuclear cells (PBMCs) aliquots from 45 HAART-treated patients were randomly chosen for population V3 sequencing on proviral-DNA at local HIV centre and at reference-laboratory Viral tropism was predicted by Geno2Pheno algorithm (False Positive Rate [FPR] = 20%) as proposed by the European-Guidelines. Quantification of total HIV-1 DNA was based on a method described by Viard (2004). Results: Quantification of HIV-1 DNA was available for 35\/45 (77.8%) samples, and gave a median value of 598 (IQR:252-1,203) copies\/10(6) PBMCs. A total of 56\/60 (93.3%) samples were successfully amplified by both the reference and the local virological centers. The overall concordance of tropism prediction between local and reference centers was 54\/56 (96.4%). Results of tropism prediction by local centers were: 33\/54 (61.1%) R5 and 21\/54 (38.9%) X4\/DM. Conclusion: There was high concordance in the genotypic tropism prediction based on proviral DNA among different virological centers throughout Italy. Our results are in line with other European studies, and support the use of genotypic tropism testing on proviral DNA in patients with suppressed plasma HIV-1 RNA candidate to CCR5-antagonist treatment."

44. Analysis of genetic and viral determinants of HBsAg levels in patients with chronic HBV infection.

Author

Vergori A, Rossetti B, Vicenti I, Meini G, Lentini G, Valoriani B, Caudai C, Morandi M, Cusi MG, Zazzi M, and De Luca A

Subjects
Genotype, Humans, Interferons, Polymorphism, Single Nucleotide, Hepatitis B immunology, Hepatitis B Surface Antigens genetics, Hepatitis B virus
Abstract

Single nucleotide polymorphisms (SNPs) in the interleukin 28B (IL28B) gene can influence the course of treated and untreated HBV infection. However, the correlation between different IL28B-SNPs and HBVDNA and quantitative HBsAg (qHBsAg) in chronic HBV infection remains to be fully elucidated. Patients with chronic HBV infection were analysed for qHBsAg, HBVDNA, HBV genotype and six IL28B-SNPs (rs12980275, rs8105790, rs8099917, rs7248668, rs12979860, rs10853728). Seventy patients were recruited: 80% Caucasian, 56% genotype D, 44% treated with nucleos(t)ide analogues, 11% cirrhotic, 37% inactive carriers (IC). Median (IQR) qHBsAg and HBVDNA were 3.2 log10 IU/ml (2.2-3.9) and 2.2 log10 IU/ml (0.3-3.3), respectively. Lower levels of qHBsAg were associated in the whole study population with rs12979860 CC vs. CT (p=0.05), rs12980275 AA vs. AG (p=0.04), rs8105790 TT vs. CT (p=0.05) and genotype D vs. A+E (p=0.01). rs8105790 TT was present in 81% of IC vs. 46% non-IC (p=0.005). These data were also confirmed in the untreated patients' subgroup. In multivariate analysis, IL28B-SNP haplogroups were associated with lower qHBsAg: CC/AA at rs12979860/rs12980275 (-0.70 log IU/mL, 95% CI -1.26;-0.14; p=0.01), CC/TT at rs12979860/rs8105790 (-0.78 log IU/mL, 95% CI -1.33;-0.23; p=0.006) and AA/TT at rs12980275/rs8105790 (-0.71 log IU/mL, 95% CI -1.27;-0.17; p=0.01) both in the whole population and in the untreated subgroup. Specific IL28-SNP haplogroups might be associated with lower qHBsAg.

Published
2020

46. Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy: 48-week results of a randomized trial.

Author

Rossetti B, Gagliardini R, Meini G, Sterrantino G, Colangeli V, Re MC, Latini A, Colafigli M, Vignale F, Rusconi S, Micheli V, Di Biagio A, Orofino G, Ghisetti V, Fantauzzi A, Vullo V, Grima P, Francisci D, Mastroianni C, Antinori A, Trezzi M, Lisi L, Navarra P, Canovari B, D'Arminio Monforte A, Lamonica S, D'Avino A, Zazzi M, Di Giambenedetto S, and De Luca A

Subjects
Adult, Anti-HIV Agents adverse effects, Antiretroviral Therapy, Highly Active adverse effects, Antiretroviral Therapy, Highly Active standards, Cyclohexanes adverse effects, Darunavir adverse effects, Drug Therapy, Combination adverse effects, Female, HIV Infections virology, HIV-1 drug effects, Humans, Male, Maraviroc, Middle Aged, Ritonavir administration & dosage, Treatment Outcome, Triazoles adverse effects, Viral Load drug effects, Anti-HIV Agents administration & dosage, Cyclohexanes administration & dosage, Darunavir administration & dosage, HIV Infections drug therapy, Triazoles administration & dosage
Abstract

Objectives: Primary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48., Methods: Patients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm)., Results: In June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm., Conclusion: Switching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy.

Published
2017
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47. Drug resistance testing through remote genotyping and predicted treatment options in human immunodeficiency virus type 1 infected Tanzanian subjects failing first or second line antiretroviral therapy.

Author

Svärd J, Mugusi S, Mloka D, Neogi U, Meini G, Mugusi F, Incardona F, Zazzi M, and Sönnerborg A

Subjects
Adult, Alkynes, Antiretroviral Therapy, Highly Active, Atazanavir Sulfate therapeutic use, Benzoxazines therapeutic use, Clinical Decision-Making, Computational Biology, Cross-Sectional Studies, Cyclopropanes, Emtricitabine therapeutic use, Female, HIV Infections virology, HIV-1 classification, HIV-1 drug effects, HIV-1 growth & development, Humans, Lamivudine therapeutic use, Lopinavir therapeutic use, Male, Monitoring, Physiologic, Nevirapine therapeutic use, Stavudine therapeutic use, Tanzania, Tenofovir therapeutic use, Treatment Failure, Viral Load drug effects, pol Gene Products, Human Immunodeficiency Virus genetics, Anti-HIV Agents therapeutic use, Drug Resistance, Viral genetics, Genotype, HIV Infections drug therapy, HIV-1 genetics
Abstract

Introduction: Antiretroviral therapy (ART) has been successfully introduced in low-middle income countries. However an increasing rate of ART failure with resistant virus is reported. We therefore described the pattern of drug resistance mutations at antiretroviral treatment (ART) failure in a real-life Tanzanian setting using the remote genotyping procedure and thereafter predicted future treatment options using rule-based algorithm and the EuResist bioinformatics predictive engine. According to national guidelines, the default first-line regimen is tenofovir + lamivudine + efavirenz, but variations including nevirapine, stavudine or emtricitabine can be considered. If failure on first-line ART occurs, a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) and boosted lopinavir or atazanavir is recommended., Materials and Methods: Plasma was obtained from subjects with first (n = 174) or second-line (n = 99) treatment failure, as defined by clinical or immunological criteria, as well as from a control group of ART naïve subjects (n = 17) in Dar es Salaam, Tanzania. Amplification of the pol region was performed locally and the amplified DNA fragment was sent to Sweden for sequencing (split genotyping procedure). The therapeutic options after failure were assessed by the genotypic sensitivity score and the EuResist predictive engine. Viral load was quantified in a subset of subjects with second-line failure (n = 52)., Results: The HIV-1 pol region was successfully amplified from 55/174 (32%) and 28/99 (28%) subjects with first- or second-line failure, respectively, and 14/17 (82%) ART-naïve individuals. HIV-1 pol sequence was obtained in 82 of these 97 cases (84.5%). Undetectable or very low (<2.6 log10 copies/10-3 L) viral load explained 19 out of 25 (76%) amplification failures in subjects at second-line ART failure. At first and second line failure, extensive accumulation of NRTI (88% and 73%, respectively) and NNRTI (93% and 73%, respectively) DRMs but a limited number of PI DRMs (11% at second line failure) was observed. First line failure subjects displayed a high degree of cross-resistance to second-generation NNRTIs etravirine (ETR; 51% intermediate and 9% resistant) and rilpivirine (RPV; 12% intermediate and 58% resistant), and to abacavir (ABC; 49% resistant) which is reserved for second line therapy in Tanzania. The predicted probability of success with the best salvage regimen at second-line failure decreased from 93.9% to 78.7% when restricting access to the NRTIs, NNRTIs and PIs currently available in Tanzania compared to when including all approved drugs., Discussion: The split genotyping procedure is potential tool to analyse drug resistance in Tanzania but the sensitivity should be evaluated further. The lack of viral load monitoring likely results in a high false positive rate of treatment failures, unnecessary therapy switches and massive accumulation of NRTI and NNRTI mutations. The introduction of regular virological monitoring should be prioritized and integrated with drug resistance studies in resource limited settings.

Published
2017
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48. Total cellular HIV-1 DNA decreases after switching to raltegravir-based regimens in patients with suppressed HIV-1 RNA.

Author

Rossetti B, Meini G, Bianco C, Lamonica S, Mondi A, Belmonti S, Fanti I, Ciccarelli N, Di Giambenedetto S, Zazzi M, and De Luca A

Subjects
Adult, Anti-HIV Agents administration & dosage, Female, HIV Infections drug therapy, HIV Infections virology, HIV Integrase Inhibitors therapeutic use, HIV-1 genetics, Humans, Leukocytes, Mononuclear virology, Male, Middle Aged, Raltegravir Potassium administration & dosage, Viral Load drug effects, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, DNA, Viral blood, HIV-1 isolation & purification, RNA, Viral blood, Raltegravir Potassium therapeutic use
Abstract

Background: The integrase inhibitor raltegravir has been used to intensify antiretroviral therapy in patients with undetectable plasma HIV-1RNA, resulting in variable perturbation of HIV-1 nucleic acids levels in peripheral blood., Objectives: We aimed at monitoring residual plasma HIV-1RNA and total cellular HIV-1DNA in virologically suppressed patients switching to raltegravir-based regimens., Study Design: Fifty-eight subjects on protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimens, with plasma HIV-1RNA levels <40 copies/ml for ≥6 months and CD4 counts >200cells/μl for ≥12 months were enrolled. Thirty-four patients were from the treatment simplification RASTA randomized study switching standard therapy to a raltegravir-based regimen (RASTA group), while 24 continued a PI or NNRTI based-regimen (controls). Residual plasma HIV-1RNA (5-40copies/mL) and HIV-1DNA were assessed at 0, 24 and 48 weeks., Results: At week 0 (W0), HIV-1DNA was detected in all patients while at W48 it was detectable in 82.4% of the RASTA group vs 100% of controls (p=0.03). There was a significant decline of HIV-1DNA at W48 in the RASTA group (mean change from baseline -0.21 [95% CI -0.41; -0.01] log 10 copies/10 6 CD4; p=0.03) but not in controls. Ultrasensitive HIV-1RNA was detectable at baseline in 50% of RASTA group vs 67% of controls and at W48 in 32.4% vs 42%, respectively. No differences were found between HIV-1RNA levels at baseline and W48 within and between groups., Conclusions: Switching successful therapy to raltegravir-based regimens may be associated with a decrease of the HIV-1 reservoir, as measured by peripheral blood cellular HIV-1DNA levels., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Published
2017
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49. Dysfunctional phenotypes of CD4+ and CD8+ T cells are comparable in patients initiating ART during early or chronic HIV-1 infection.

Author

Amu S, Lantto Graham R, Bekele Y, Nasi A, Bengtsson C, Rethi B, Sorial S, Meini G, Zazzi M, Hejdeman B, and Chiodi F

Subjects
Adult, Cross-Sectional Studies, DNA, Viral analysis, Female, Follow-Up Studies, HIV Infections drug therapy, HIV Infections virology, HIV-1 genetics, Humans, Male, Time Factors, Anti-Retroviral Agents therapeutic use, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, HIV Infections immunology, HIV-1 immunology, Lymphocyte Activation drug effects, Viral Load immunology
Abstract

Early initiation of antiretroviral therapy (ART) is becoming a common clinical practice according to current guidelines recommending treatment to all HIV-1-infected patients. However, it is not known whether ART initiated during the early phase of infection prevents the establishment of abnormal phenotypic features previously reported in CD4+ and CD8+T cells during chronic HIV-1 infection. In this cross-sectional study, blood specimens were obtained from 17 HIV-1-infected patients who began ART treatment shortly after infection (early ART [EA]), 17 age-matched HIV-1-infected patients who started ART during chronic phase of infection (late ART [LA]), and 25 age-matched non-HIV-1-infected controls. At collection of specimens, patients in EA and LA groups had received ART for comparable periods of time. Total HIV-1 DNA was measured in white blood cells by quantitative PCR. The concentration of 9 inflammatory parameters and 1 marker of fibrosis, including sCD14 and β-2 microglobulin, was measured in plasma. Furthermore, expression of markers of abnormal immune activation (human leukocyte antigen - antigen D related [HLA-DR] and CD38), exhaustion (programmed death 1, CD28, CD57) and terminal differentiation (CD127) was measured on CD4+ and CD8+T cells. T-cell proliferation was measured through Ki67 expression. The copies of total HIV-1 DNA in blood were significantly lower (P = 0.009) in EA compared with that in LA group. Only the expression of HLA-DR on naïve CD4+ T cells distinguished EA from LA, whereas expression of 3 surface markers distinguished T-cell populations of HIV-1-infected patients from controls. These included HLA-DR distinguishing CD4+ T cells from EA compared with controls, and also CD38 and CD127 on CD4+ and CD8+ T cells, respectively, distinguishing both groups of patients from controls. The sCD14 levels were significantly higher in EA patients, and β-2 microglobulin levels were higher in LA group compared with that in controls. Our results demonstrate an equivalent abnormal expression of activation (HLA-DR and CD38 on CD4+ T cells) and terminal differentiation (CD127 on CD8+ T cells) markers in T cells from both EA and LA patients. The size of total HIV-1 DNA copies in blood of EA was lower compared with LA patients. These findings suggest that some abnormalities taking place in the T-cell compartment during primary HIV-1 infection may not be corrected by early ART.

Published
2016
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50. First external quality assurance program of the Italian HLA-B*57:01 Network assessing the performance of clinical virology laboratories in HLA-B*57:01 testing.

Author

Meini G, Dello Russo C, Allice T, Barresi R, D'Arrigo R, Falasca F, Lipsi MR, Paolucci S, Zanussi S, Antonetti R, Baldanti F, Basaglia G, Bruzzone B, Polilli E, Ghisetti V, Pucillo LP, Turriziani O, Pirazzoli A, Navarra P, and Zazzi M

Subjects
Anti-HIV Agents administration & dosage, Anti-HIV Agents adverse effects, Clinical Laboratory Techniques methods, Dideoxynucleosides administration & dosage, Dideoxynucleosides adverse effects, Drug Hypersensitivity prevention & control, Genotyping Techniques methods, Humans, Italy, Quality Assurance, Health Care, Clinical Laboratory Techniques standards, Drug Hypersensitivity diagnosis, Genotyping Techniques standards, HLA-B Antigens genetics, Laboratory Proficiency Testing
Abstract

Background: Since the HLA-B*57:01 allele is strongly associated with abacavir hypersensitivity reaction, testing for the presence of HLA-B*57:01 is mandatory before administration of abacavir. While HLA-B*57:01 testing is usually provided by pharmacogenetics, genetics or blood transfusion services, clinical virology laboratories can be an optimal opportunity for HLA-B*57:01 testing since they receive blood samples for routine HIV monitoring and have the expertise for convenient and less expensive PCR-based point mutation assays., Objectives: The Italian HLA-B*57:01 Network gathers accredited clinical virology laboratories offering HLA-B*57:01 testing in Italy with the aim to share protocols, test new methods, develop and maintain external quality assurance (EQA) programs., Study Design: A panel of 9HLA-B*57:01-positive and 16HLA-B*57:01-negative frozen blood samples were blindly distributed to 10 units including 9 clinical virology laboratories and one reference pharmacology laboratory. Each laboratory was free to use its own routine method for DNA extraction and HLA-B*57:01 testing., Results: DNA was extracted by automated workstations in 6 units and by manual spin columns in 4. Eight units used the Duplicα Real Time HLA-B*57:01 kit by Euroclone and two units used two different PCR homemade protocols. All the 10 units correctly identified all the 25 samples., Conclusions: The first HLA-B*57:01 EQA program run in Italy showed that clinical virology units are equipped and proficient for providing HLA-B*57:01 testing by inexpensive assays easy to integrate into their routine., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Published
2016
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