14 results on '"Szabo, S."'
Search Results
2. The effect of multivitamins and polyvalent cations on virologic suppression with integrase strand transfer inhibitors.
- Author
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James CW, Szabo S, Kahal D, and Goldstein ND
- Subjects
- Cations therapeutic use, Drug Resistance, Viral, Humans, Integrases therapeutic use, HIV Infections drug therapy, HIV Integrase, HIV Integrase Inhibitors pharmacology
- Published
- 2020
- Full Text
- View/download PDF
3. HIV Testing, Patient Choice, and Diminishing Delaware's HIV Burden.
- Author
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Bennett N and Szabo S
- Subjects
- Adolescent, Adult, Delaware epidemiology, HIV Infections epidemiology, HIV Infections prevention & control, Humans, Middle Aged, Patient Acceptance of Health Care, Practice Guidelines as Topic, HIV Infections diagnosis, Mass Screening methods
- Published
- 2015
4. Update on the prevalence of antiretroviral drug resistance in treatment-naive individuals.
- Author
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James CW, Preininger LE, and Szabo S
- Subjects
- Anti-HIV Agents therapeutic use, HIV isolation & purification, HIV Infections diagnosis, HIV Infections drug therapy, Humans, Prevalence, Drug Resistance, Viral genetics, HIV physiology, HIV Infections epidemiology
- Published
- 2013
- Full Text
- View/download PDF
5. Long-term Medication Adherence in Patients Receiving Antiretroviral Drug Therapy.
- Author
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Preininger L, Cantwell-McNelis K, James C, Sullivan MC, Szabo S, and Bincsik A
- Subjects
- Adult, Female, HIV Infections virology, Humans, Male, Middle Aged, Prospective Studies, Viral Load, Anti-Retroviral Agents therapeutic use, HIV Infections drug therapy, Medication Adherence psychology, Medication Adherence statistics & numerical data
- Abstract
Objective: A long-term medication adherence project was designed and implemented in an urban HIV clinic to address antiretroviral medication adherence., Design and Methods: We conducted a prospective study of patients on long-term antiretroviral therapy. Referred patients were on antiretroviral agents at least six months and had two consecutive detectable viral loads. A standarized form was utilized to assess medication adherence, including patient report, practitioner assessed barriers, and pharmacy refill history. Individualized interventions were developed to accommodate patient needs., Results: Seventy-eight patients met inclusion criteria for a total of 81 cases per study protocol. The majority of cases had an identifiable cause related to missed and/or mistimed doses. Following adherence interventions, 51 of the 81 cases (63%) experienced a successful outcome. In addition, 16 of the 27 cases (59%) without an identifiable cause became undetectable following intervention., Conclusions: This novel approach demonstrates that a proactive method for addressing barriers to long-term medication adherence yields improved patient understanding and preservation of treatment regimens.
- Published
- 2011
- Full Text
- View/download PDF
6. Low-level viremia associated with the use of TaqMan assay.
- Author
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Szabo S, Moffett LE, Cantwell-McNelis K, James CW, and Joseph A
- Subjects
- Adult, Anti-Retroviral Agents pharmacology, Anti-Retroviral Agents therapeutic use, Branched DNA Signal Amplification Assay, Female, HIV Infections drug therapy, HIV-1 drug effects, HIV-1 physiology, Humans, Male, Middle Aged, RNA, Viral blood, Reagent Kits, Diagnostic, Sensitivity and Specificity, Viremia drug therapy, HIV Infections virology, HIV-1 isolation & purification, Polymerase Chain Reaction methods, Taq Polymerase, Viral Load physiology, Viremia virology
- Abstract
Poor correlation has been reported between the Roche Cobas AmpliPrep/Cobas (TaqMan) HIV-1 TaqMan assay and the Roche Cobas Amplicor HIV-1 Monitor version 1.5 Amplicor assay. We report 8 patients who experienced unexplained detectable viremia, despite exemplary medication adherence, following a change in viral quantification assay from Amplicor to TaqMan in January 2008. All patients were found to have undetectable HIV RNA by branched DNA (bDNA) assay.
- Published
- 2010
- Full Text
- View/download PDF
7. Prevalence of antiretroviral drug resistance in antiretroviral-naive individuals.
- Author
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James CW, Moffett LE, and Szabo S
- Subjects
- Anti-Retroviral Agents therapeutic use, CD4 Lymphocyte Count, Cohort Studies, Delaware, Drug Resistance, Viral drug effects, Female, Genotype, HIV-1 drug effects, Humans, Male, Mutation, RNA, Viral, Retrospective Studies, Urban Population, Drug Resistance, Viral genetics, HIV Infections drug therapy, HIV Infections virology, HIV Reverse Transcriptase genetics, HIV-1 genetics
- Abstract
Transmitted antiretroviral drug resistance has been an ongoing consideration even in patients who are treatment naive. The authors retrospectively selected all eligible patients from a US-based urban HIV clinic who had a genotypic resistance assay performed prior to the initiation of antiretroviral therapy. Clinically significant resistance was detected in 8% of assays, and was comparable when stratified by duration of time from diagnosis to genotypic resistance assay.
- Published
- 2009
- Full Text
- View/download PDF
8. Case presentation: nephrolithiasis in a patient treated with atazanavir.
- Author
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Savini C, James C, Wilson S, Martin H, Szabo S, and Scotto V
- Subjects
- Adult, Atazanavir Sulfate, Female, HIV Infections complications, Humans, Nephrolithiasis complications, HIV Infections drug therapy, HIV Protease Inhibitors adverse effects, Nephrolithiasis chemically induced, Oligopeptides adverse effects, Pyridines adverse effects
- Abstract
Of the recently approved antiretroviral protease inhibitors, atazanavir has become a popular medication for the treatment of HIV infection. The advantages of an atazanavir-based regimen include a favorable side effect profile, low impact on lipids, low pill burden, and daily dosing. These have made it a favorable choice for antiretroviral treatment. As more experience is gained with newer antiretroviral medications, additional side effects become apparent. Recent reports have highlighted occurrences of nephrolithiasis in patients using atazanavir-based regimens. The authors present a case of a patient who experienced nephrolithiasis while taking combination antiretroviral therapy that included atazanavir.
- Published
- 2008
- Full Text
- View/download PDF
9. The effects of an HIV-1 immunogen (Remune) on viral load, CD4 cell counts and HIV-specific immunity in a double-blind, randomized, adjuvant-controlled subset study in HIV infected subjects regardless of concomitant antiviral drugs.
- Author
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Turner JL, Kostman JR, Aquino A, Wright D, Szabo S, Bidwell R, Goodgame J, Daigle A, Kelley E, Jensen F, Duffy C, Carlo D, and Moss RB
- Subjects
- AIDS Vaccines immunology, AIDS Vaccines pharmacology, Adult, Antiviral Agents therapeutic use, CD4 Lymphocyte Count, Disease Progression, Double-Blind Method, Female, Freund's Adjuvant therapeutic use, HIV-1 genetics, Humans, Immunity, Cellular, Male, RNA, Viral blood, Time Factors, Viral Load, AIDS Vaccines therapeutic use, HIV Infections immunology, HIV Infections therapy, HIV-1 immunology
- Abstract
Objective: We examined the activity of an HIV-1 immunogen (Remune) on viral load, CD4 cells and HIV-1 specific immunity., Methods: Plasma and peripheral blood mononuclear cells were obtained in a predefined random subset of subjects (n = 252) from a multicentre, double-blind, adjuvant-controlled phase III clinical endpoint study., Results: The subjects treated with the HIV-1 immunogen had a significantly greater decline in viral load at multiple time points (P < 0.05), a trend towards increased CD4+ T cell counts and significantly enhanced HIV-1 specific immune responses as measured by HIV-1 lymphocyte proliferation (P < 0.001) compared to the adjuvant control group. Furthermore, in the HIV-1 immunogen treated group, enhanced HIV-1 specific lymphocyte proliferative immune responses were associated with decreased HIV-1 plasma RNA., Conclusion: These results suggest that, in a predefined, random subset of subjects, a beneficial effect of the HIV-1 immunogen was observed on viral load, CD4+ T cells, and HIV-specific immunity. These differences were observed in a background of multiple drug therapies. Ongoing trials are evaluating the effect of the combination of this HIV-1 specific, immune-based therapy with potent antiviral drug therapy on virological outcomes.
- Published
- 2001
- Full Text
- View/download PDF
10. A controlled trial of isoniazid in persons with anergy and human immunodeficiency virus infection who are at high risk for tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS.
- Author
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Gordin FM, Matts JP, Miller C, Brown LS, Hafner R, John SL, Klein M, Vaughn A, Besch CL, Perez G, Szabo S, and El-Sadr W
- Subjects
- Adult, Antitubercular Agents adverse effects, Double-Blind Method, Female, HIV Infections immunology, Humans, Isoniazid adverse effects, Male, Middle Aged, Risk Factors, Treatment Outcome, AIDS-Related Opportunistic Infections prevention & control, Antitubercular Agents therapeutic use, HIV Infections drug therapy, Isoniazid therapeutic use, Tuberculosis, Pulmonary prevention & control
- Abstract
Background: Patients with human immunodeficiency virus (HIV) infection and latent tuberculosis are at substantial risk for the development of active tuberculosis. As a public health measure, prophylactic treatment with isoniazid has been suggested for HIV-infected persons who have anergy and are in groups with a high prevalence of tuberculosis., Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial of six months of prophylactic isoniazid treatment in HIV-infected patients with anergy who have risk factors for tuberculosis infection. The primary end point was culture-confirmed tuberculosis., Results: The study was conducted from November 1991 through June 1996. Over 90 percent of the patients had two or more risk factors for tuberculosis infection, and nearly 75 percent of patients were from greater New York City. After a mean follow-up of 33 months, tuberculosis was diagnosed in only 6 of 257 patients in the placebo group and 3 of 260 patients in the isoniazid group (risk ratio, 0.48; 95 percent confidence interval, 0.12 to 1.91; P=0.30). There were no significant differences between the two groups with regard to death, death or the progression of HIV disease, or adverse events., Conclusions: Even in HIV-infected patients with anergy and multiple risk factors for latent tuberculosis infection, the rate of development of active tuberculosis is low. This finding does not support the use of isoniazid prophylaxis in high-risk patients with HIV infection and anergy unless they have been exposed to active tuberculosis.
- Published
- 1997
- Full Text
- View/download PDF
11. The effect of Pneumocystis carinii pneumonia prophylaxis regimens on the incidence of bacterial infections in HIV-infected patients.
- Author
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Mayer HB, Rose DN, Cohen S, Gurtman AC, Cheung TW, and Szabo S
- Subjects
- AIDS-Related Opportunistic Infections complications, AIDS-Related Opportunistic Infections drug therapy, Adult, Bacterial Infections complications, Cohort Studies, Female, Humans, Male, Pneumonia, Pneumocystis complications, Bacterial Infections drug therapy, HIV Infections complications, Pentamidine therapeutic use, Pneumonia, Pneumocystis prevention & control, Trimethoprim, Sulfamethoxazole Drug Combination therapeutic use
- Published
- 1993
- Full Text
- View/download PDF
12. Circulating microRNAs in Sera Correlate with Soluble Biomarkers of Immune Activation but Do Not Predict Mortality in ART Treated Individuals with HIV-1 Infection: A Case Control Study
- Author
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Murray, D. D., Suzuki, K., Law, M., Trebicka, J., Neuhaus, J., Wentworth, D., Johnson, M., Vjecha, M. J., Kelleher, A. D., Emery, S., Aagaard, B., Aragon, E., Arnaiz, J., Borup, L., Clotet, B., Dragsted, U., Fau, A., Gey, D., Grarup, J., Hengge, U., Herrero, P., Jansson, P., Jensen, B., Jensen, K., Juncher, H., Lopez, P., Lundgren, J. D., Matthews, C., Mollerup, D., Pearson, M., Phillips, A., Reilev, S., Tillmann, K., Varea, S., Angus, B., Babiker, A., Cordwell, B., Darbyshire, J., Dodds, W., Fleck, S., Horton, J., Hudson, F., Moraes, Y., Pacciarini, F., Palfreeman, A., Paton, N., Smith, N., Van Hooff, F., Bebchuk, J., Collins, G., Denning, E., Duchene, A., Fosdick, L., Harrison, M., Herman-Lamin, K., Krum, E., Larson, G., Neaton, J., Nelson, R., Quan, K., Quan, S., Schultz, T., Thompson, G., Wyman, N., Carey, C., Chan, F., Cooper, D., Courtney-Rodgers, D., Drummond, F., Harrod, M., Jacoby, S., Kearney, L., Lin, E., Pett, S., Robson, R., Seneviratne, N., Stewart, M., Watts, E., Finley, E., Gordin, F., Sanchez, A., Standridge, B., Belloso, W., Davey, R., Duprez, D., Gatell, J., Hoy, J., Lifson, A., Pederson, C., Perez, G., Price, R., Prineas, R., Rhame, F., Sampson, J., Worley, J., Modlin, J., Beral, V., Chaisson, R., Fleming, T., Hill, C., Kim, K., Murray, B., Pick, B., Seligmann, M., Weller, I., Cahill, K., Fox, L., Luzar, M., Martinez, A., Mcnay, L., Pierson, J., Tierney, J., Vogel, S., Costas, V., Eckstrand, J., Brown, S., Abusamra, L., Angel, E., Aquilia, S., Benetucci, J., Bittar, V., Bogdanowicz, E., Cahn, P., Casiro, A., Contarelli, J., Corral, J., Daciuk, L., David, D., Dobrzanski, W., Duran, A., Ebenrstejin, J., Ferrari, I., Fridman, D., Galache, V., Guaragna, G., Ivalo, S., Krolewiecki, A., Lanusse, I., Laplume, H., Lasala, M., Lattes, R., Lazovski, J., Lopardo, G., Losso, M., Lourtau, L., Lupo, S., Maranzana, A., Marson, C., Massera, L., Moscatello, G., Olivia, S., Otegui, I., Palacios, L., Parlante, A., Salomon, H., Sanchez, M., Somenzini, C., Suarez, C., Tocci, M., Toibaro, J., Zala, C., Agrawal, S., Ambrose, P., Anderson, C., Anderson, J., Baker, D., Beileiter, K., Blavius, K., Bloch, M., Boyle, M., Bradford, D., Britton, P., Brown, P., Busic, T., Cain, A., Carrall, L., Carson, S., Chenoweth, I., Chuah, J., Clark, F., Clemons, J., Clezy, K., Cortissos, P., Cunningham, N., Curry, M., Daly, L., D'Arcy-Evans, C., Del Rosario, R., Dinning, S., Dobson, P., Donohue, W., Doong, N., Downs, C., Edwards, E., Edwards, S., Egan, C., Ferguson, W., Finlayson, R., Forsdyke, C., Foy, L., Franic, T., Frater, A., French, M., Gleeson, D., Gold, J., Habel, P., Haig, K., Hardy, S., Holland, R., Hudson, J., Hutchison, R., Hyland, N., James, R., Johnston, C., Kelly, M., King, M., Kunkel, K., Lau, H., Leamy, J., Lester, D., Leung, J., Lohmeyer, A., Lowe, K., Macrae, K., Magness, C., Martinez, O., Maruszak, H., Medland, N., Miller, S., Murray, J., Negus, P., Newman, R., Ngieng, M., Nowlan, C., Oddy, J., Orford, N., Orth, D., Patching, J., Plummer, M., Price, S., Primrose, R., Prone, I., Ree, H., Remington, C., Richardson, R., Robinson, S., Rogers, G., Roney, J., Roth, N., Russell, D., Ryan, S., Sarangapany, J., Schmidt, T., Schneider, K., Shields, C., Silberberg, C., Shaw, D., Skett, J., Smith, D., Soo, T. M., Sowden, D., Street, A., Tee, B. K., Thomson, J., Topaz, S., Vale, R., Villella, C., Walker, A., Watson, A., Wendt, N., Williams, L., Youds, D., Aichelburg, A., Cichon, P., Gemeinhart, B., Rieger, A., Schmied, B., Touzeau-Romer, V., Vetter, N., Colebunders, R., Clumeck, N., Deroo, A., Kabeya, K., O'Doherty, E., De Wit, S., De Salles Amorim, C., Basso, C., Flint, S., Kallas, E., Levi, G., Lewi, D., Pereira, L., Da Silva, M., Souza, T., Toscano, A., Angel, J., Arsenault, M., Bast, M., Beckthold, B., Bouchard, P., Chabot, I., Clarke, R., Cohen, J., Cote, P., Ellis, M., Gagne, C., Gill, J., Houde, M., Johnston, B., Jubinville, N., Kato, C., Lamoureux, N., Latendre-Paquette, J., Lindemulder, A., Mcneil, A., Mcfarland, N., Montaner, J., Morrisseau, C., O'Neill, R., Page, G., Piche, A., Pongracz, B., Preziosi, H., Puri, L., Rachlis, A., Ralph, E., Raymond, I., Rouleau, D., Routy, J. P., Sandre, R., Seddon, T., Shafran, S., Sikora, C., Smaill, F., Stromberg, D., Trottier, S., Walmsley, S., Weiss, K., Williams, K., Zarowny, D., Baadegaard, B., Andersen, A. B., Boedker, K., Collins, P., Gerstoft, J., Jensen, L., Moller, H., Andersen, P. L., Loftheim, I., Mathiesen, L., Nielsen, H., Obel, N., Pedersen, C., Petersen, D., Jensen, L. P., Black, F. T., Aboulker, J. P., Aouba, A., Bensalem, M., Berthe, H., Blanc, C., Bornarel, D., Bouchaud, O., Boue, F., Bouvet, E., Brancon, C., Breaud, S., Brosseau, D., Brunet, A., Capitant, C., Ceppi, C., Chakvetadze, C., Cheneau, C., Chennebault, J. M., De Truchis, P., Delavalle, A. M., Delfraissy, J. F., Dellamonica, P., Dumont, C., Edeb, N., Fabre, G., Ferrando, S., Foltzer, A., Foubert, V., Gastaut, J. A., Gerbe, J., Girard, P. M., Goujard, C., Hoen, B., Honore, P., Hue, H., Hynh, T., Jung, C., Kahi, S., Katlama, C., Lang, J. M., Le Baut, V., Lefebvre, B., Leturque, N., Levy, Y., Loison, J., Maddi, G., Maignan, A., Majerholc, C., De Boever, C., Meynard, J. L., Michelet, C., Michon, C., Mole, M., Netzer, E., Pialoux, G., Poizot-Martin, I., Raffi, F., Ratajczak, M., Ravaux, I., Reynes, J., Salmon-Ceron, D., Sebire, M., Simon, A., Tegna, L., Tisne-Dessus, D., Tramoni, C., Viard, J. P., Vidal, M., Viet-Peaucelle, C., Weiss, L., Zeng, A., Zucman, D., Adam, A., Arasteh, K., Behrens, G., Bergmann, F., Bickel, M., Bittner, D., Bogner, J., Brockmeyer, N., Darrelmann, N., Deja, M., Doerler, M., Esser, S., Faetkenheuer, G., Fenske, S., Gajetzki, S., Goebel, F., Gorriahn, D., Harrer, E., Harrer, T., Hartl, H., Hartmann, M., Heesch, S., Jakob, W., Jager, H., Klinker, H., Kremer, G., Ludwig, C., Mantzsch, K., Mauss, S., Meurer, A., Niedermeier, A., Pittack, N., Plettenberg, A., Potthoff, A., Probst, M., Rittweger, M., Rockstroh, J., Ross, B., Rotty, J., Rund, E., Ruzicka, T., Schmidt, R., Schmutz, G., Schnaitmann, E., Schuster, D., Sehr, T., Spaeth, B., Staszewski, S., Stellbrink, H. J., Stephan, C., Stockey, T., Stoehr, A., Trein, A., Vaeth, T., Vogel, M., Wasmuth, J., Wengenroth, C., Winzer, R., Wolf, E., Mulcahy, F., Reidy, D., Cohen, Y., Drora, G., Eliezer, I., Godo, O., Kedem, E., Magen, E., Mamorsky, M., Pollack, S., Sthoeger, Z., Vered, H., Yust, I., Aiuti, F., Bechi, M., Bergamasco, A., Bertelli, D., Bruno, R., Butini, L., Cagliuso, M., Carosi, G., Casari, S., Chrysoula, V., Cologni, G., Conti, V., Costantini, A., Corpolongo, A., D'Offizi, G., Gaiottino, F., Di Pietro, M., Esposito, R., Filice, G., Francesco, M., Gianelli, E., Graziella, C., Magenta, L., Martellotta, F., Maserati, R., Mazzotta, F., Murdaca, G., Nardini, G., Nozza, S., Puppo, F., Pogliaghi, M., Ripamonti, D., Ronchetti, C., Rusconi, S., Rusconi, V., Sacchi, P., Silvia, N., Suter, F., Tambussi, G., Uglietti, A., Vechi, M., Vergani, B., Vichi, F., Vitiello, P., Iwamoto, A., Kikuchi, Y., Miyazaki, N., Mori, M., Nakamura, T., Odawara, T., Oka, S., Shirasaka, T., Tabata, M., Takano, M., Ueta, C., Watanabe, D., Yamamoto, Y., Erradey, I., Himmich, H., El Filali, K. M., Blok, W., Van Boxtel, R., Doevelaar, K. B. H., Van Eeden, A., Grijsen, M., Groot, M., Juttmann, J., Kuipers, M., Ligthart, S., Van Der Meulen, P., Lange, J., Langebeek, N., Reiss, P., Richter, C., Schoemaker, M., Schrijnders-Gudde, L., Septer-Bijleveld, E., Sprenger, H., Vermeulen, J., Ten Kate, R., Van De Ven, B., Bruun, J., Kvale, D., Maeland, A., Bakowska, E., Beniowski, M., Boron-Kaczmarska, A., Gasiorowski, J., Horban, A., Inglot, M., Knysz, B., Mularska, E., Parczewski, M., Pynka, M., Rymer, W., Szymczak, A., Aldir, M., Antunes, F., Baptista, C., Da Conceicao Vera, J., Doroana, M., Mansinho, K., Dos Santos, C. R. A., Valadas, E., Vaz Pinto, I., Chia, E., Foo, E., Karim, F., Lim, P. L., Panchalingam, A., Quek, A., Alcazar-Caballero, R., Arribas, J., Arrizabalaga, J., De Barron, X., Blanco, F., Bouza, E., Bravo, I., Calvo, S., Carbonero, L., Carpena, I., Castro, M., Cortes, L., Del Toro, M., Domingo, P., Elias, M., Espinosa, J., Estrada, V., Fernandez-Cruz, E., Fernandez, P., Freud, H., Fuster, M., Garcia, A., Garcia, G., Garrido, R., Gijon, P., Gonzalez-Garcia, J., Gil, I., Gonzalez, A., Gonzalez-Lahoz, J., Grosso, P. L., Gutierrez, M., Guzman, E., Iribarren, J., Jimenez, M., Jou, A., Juega, J., Lopez, J., Lozano, F., Martin-Carbonero, L., Mata, R., Mateo, G., Menasalvas, A., Mirelles, C., De Miguel Prieto, J., Montes, M., Moreno, A., Moreno, J., Moreno, V., Munoz, R., Ocampo, A., Ortega, E., Ortiz, L., Padilla, B., Parras, A., Paster, A., Pedreira, J., Pena, J., Perea, R., Portas, B., Puig, J., Pulido, F., Rebollar, M., De Rivera, J., Roca, V., Rodriguez-Arrondo, F., Rubio, R., Santos, J., Sanz, J., Sebastian, G., Segovia, M., Soriano, V., Tamargo, L., Viciana, P., Von Wichmann, M., Bratt, G., Hollander, A., Olov Pehrson, P., Petz, I., Sandstrom, E., Sonnerborg, A., Bernasconi, E., 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., Fisher, M., Fox, R., Gazzard, B., Gilleran, G., Hand, J., Heald, L., Higgs, C., Jebakumar, S., Jendrulek, I., Johnson, S., Kinghorn, G., Kuldanek, K., Leen, C., Maw, R., Mckernan, S., Mclean, L., Morris, S., Murphy, M., O'Farrell, S., Ong, E., Peters, B., Stroud, C., Wansbrough-Jones, M., Weber, J., White, D., Williams, I., Wiselka, M., Yee, T., Adams, S., Allegra, D., Andrews, L., Aneja, B., Anstead, G., Arduino, R., Artz, R., Bailowitz, J., Banks, S., Baxter, J., 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., Clifford, D., Climo, M., Cohn, D., 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., Markowitz, N., Martinez, 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., Mushatt, D., Nahass, R., Nixon, D., O'Brien, S., Ojeda, J., Okhuysen, P., Olson, M., Osterberger, J., Owen, W., Pablovich, S., Patel, S., Pierone, G., Poblete, R., Potter, A., Preston, E., Rappoport, C., Regevik, N., Reyelt, M., Riney, L., Rodriguez-Barradas, 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., Tedaldi, E., 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., Vjecha, M., Schmetter, B., Grue, L., Willoughby, M., Demers, A., Dragsted, U. B., Jensen, K. B., Jansson, P. O., Jensen, B. G., Benfield, T. L., Darbyshire, J. H., Babiker, G., Fleck, S. L., Collaco-Moraes, Y., Wyzydrag, L., Drummond, F. M., Connor, S. A., Satchell, C. S., Gunn, S., Delfino, M. A., Merlin, K., Mcginley, C., Neaton, J. D., Bartsch, G., George, M., Grund, B., Hogan, C., Miller, C., Roediger, M. P., Thackeray, L., Campbell, C., Lahart, C., Perlman, D., Rein, M., Dersimonian, R., Brody, B. A., Daar, E. S., Dubler, N. N., Fleming, T. R., Freeman, D. J., Kahn, J. P., Kim, K. M., Medoff, G., Modlin, J. F., Moellering, R., Murray, B. E., Robb, M. L., Scharfstein, D. O., Sugarman, J., Tsiatis, A., Tuazon, C., Zoloth, L., Klingman, K., Lehrman, S., Belloso, W. H., Losso, M. H., Benetucci, J. A., Bogdanowicz, E. P., Cahn, P. E., Casiro, A. D., Cassetti, I., Contarelli, J. M., Corral, J. A., Crinejo, A., David, D. O., Ishida, M. T., Laplume, H. E., Lasala, M. B., Lupo, S. H., Masciottra, F., Michaan, M., Ruggieri, L., Salazar, E., Hoy, J. F., Rogers, G. D., Allworth, A. M., Anderson, J. S. C., Armishaw, J., Barnes, K., Carr, A., 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., Dewit, S., 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, 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., Reyes, M. J. W., Northland, R., Ostergaard, L., Hergens, L., Loftheim, I. R., Raukas, M., Zilmer, K., Justinen, J., Ristola, M., Landman, R., Abel, S., Abgrall, S., Amat, K., Auperin, L., Barruet, R., Benalycherif, A., Benammar, N., Bentata, M., Besnier, J. M., Blanc, M., Cabie, A., Chavannet, P., Dargere, S., De La Tribonniere, X., Debord, T., Decaux, N., Delgado, J., Dupon, M., Durant, J., Frixon-Marin, V., Genet, C., Gerard, L., Gilquin, J., Jeantils, V., Kouadio, H., Leclercq, P., Lelievre, J. D., 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., Fatkenheuer, G., Bitsch, S., Bogner, J. R., Goebel, F. D., Lehmann, C., Lennemann, T., 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., Panos, G., Paparizos, V., Papastamopoulos, V., Petrikkos, G., Sambatakou, H., Skoutelis, A., Tsogas, N., Xylomenos, G., Bergin, C. J., Mooka, B., Mamorksy, M. G., Agmon-Levin, N., Karplus, R., Maayan, S., Shahar, E., Turner, D., Abeli, C., Biglino, A., Bonora, S., De Gioanni, M., Di Perri, G., Montroni, M., Quirino, T., Raise, E., Honda, M., Ishisaka, M., Caplinskas, S., Uzdaviniene, V., Schmit, J. C., Staub, T., Mills, G. D., Blackmore, T., Masters, J. A., Morgan, J., Pithie, A., Brunn, J., Ormassen, 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., Rakhmanova, A., Vinogradova, E., Yakovlev, A., Zakharova, N., 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., Hirschel, B., Spycher, R., Battegay, M., Bottone, S., Cavassini, M., Christen, A., Furrer, H. J., Gayet-Ageron, A., Genne, D., Hochstrasser, S., Moens, C., Muller, N., Nuesch, 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, S., Peto, T. E. A., Portsmouth, S. D., Rajamanoharan, S., Ronan, Schwenk, A., Slinn, M. A., Stroud, C. J., Thomas, R. C., Wansbrough-Jones, M. H., Whiles, H. J., White, D. J., Williams, E., Williams, G., Youle, M., Abrams, D. I., 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, 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, E., Campbell, B., Caras, S., Carroll, J., Casey, K. K., Chiang, F., Cindrich, R. B., Cohen, C., Coley, J., Condoluci, D. V., Contreras, R., Corser, J., Cozzolino, J., Crane, L. R., Daley, L., Dandridge, D., D'Antuono, V., Darcourt Rizo Patron, J. G., Dehovitz, J. A., Dejesus, E., Desjardin, J., Dietrich, C., Dolce, A., 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., Friedland, G., 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, 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., Luskin-Hawk, R., 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 Derouen, V., Rosmarin, C., Rossen, W. L., Rouff, J. R., Sands, M., Savini, C., Schrader, S., Schulte, M. M., Scott, R., Seedhom, H., Sension, M., Sheblehall, 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., Bong, C. T. H., Vaccaro, A., Vasco, L. M., Vecino, I., Verlinghieri, G. K., Visnegarwala, F., Wade, H., Weis, S. E., Weise, J. A., Weissman, S., Wilkin, M., Witter, J. H., Wojtusic, L., Wright, T. J., Yeh, V., Young, B., Zeana, C., Zeh, J., Savio, E., Vacarezza, M., and Pacheco, Antonio Guilherme
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Adult ,CD4-Positive T-Lymphocytes ,Male ,General Science & Technology ,Anti-HIV Agents ,T cell ,lcsh:Medicine ,Antiretroviral Therapy ,HIV Infections ,Biology ,Essential hypertension ,Logistic regression ,Malignancy ,Acquired immunodeficiency syndrome (AIDS) ,Clinical Research ,Antiretroviral Therapy, Highly Active ,microRNA ,medicine ,Genetics ,2.1 Biological and endogenous factors ,Humans ,Highly Active ,Aetiology ,lcsh:Science ,Genetic Association Studies ,Multidisciplinary ,lcsh:R ,Case-control study ,Middle Aged ,medicine.disease ,3. Good health ,Circulating MicroRNA ,MicroRNAs ,medicine.anatomical_structure ,Infectious Diseases ,Good Health and Well Being ,INSIGHT ESPRIT and SMART Study Groups ,Immunology ,HIV-1 ,HIV/AIDS ,lcsh:Q ,Female ,Infection ,Biomarkers ,Biotechnology ,Research Article - Abstract
Introduction The use of anti-retroviral therapy (ART) has dramatically reduced HIV-1 associated morbidity and mortality. However, HIV-1 infected individuals have increased rates of morbidity and mortality compared to the non-HIV-1 infected population and this appears to be related to end-organ diseases collectively referred to as Serious Non-AIDS Events (SNAEs). Circulating miRNAs are reported as promising biomarkers for a number of human disease conditions including those that constitute SNAEs. Our study sought to investigate the potential of selected miRNAs in predicting mortality in HIV-1 infected ART treated individuals. Materials and Methods A set of miRNAs was chosen based on published associations with human disease conditions that constitute SNAEs. This case: control study compared 126 cases (individuals who died whilst on therapy), and 247 matched controls (individuals who remained alive). Cases and controls were ART treated participants of two pivotal HIV-1 trials. The relative abundance of each miRNA in serum was measured, by RTqPCR. Associations with mortality (all-cause, cardiovascular and malignancy) were assessed by logistic regression analysis. Correlations between miRNAs and CD4+ T cell count, hs-CRP, IL-6 and D-dimer were also assessed. Results None of the selected miRNAs was associated with all-cause, cardiovascular or malignancy mortality. The levels of three miRNAs (miRs -21, -122 and -200a) correlated with IL-6 while miR-21 also correlated with D-dimer. Additionally, the abundance of miRs -31, -150 and -223, correlated with baseline CD4+ T cell count while the same three miRNAs plus miR-145 correlated with nadir CD4+ T cell count. Discussion No associations with mortality were found with any circulating miRNA studied. These results cast doubt onto the effectiveness of circulating miRNA as early predictors of mortality or the major underlying diseases that contribute to mortality in participants treated for HIV-1 infection.
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- 2015
13. 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. 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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
14. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection
- Author
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Michael, Kozal, Judith, Aberg, Gilles, Pialoux, Pedro, Cahn, Melanie, Thompson, Jean-Michel, Molina, Beatriz, Grinsztejn, Ricardo, Diaz, Antonella, Castagna, Princy, Kumar, Gulam, Latiff, Edwin, DeJesus, Mark, Gummel, Margaret, Gartland, Amy, Pierce, Peter, Ackerman, Cyril, Llamoso, Max, Lataillade, A, Wurcel, Yale School of Medicine [New Haven, Connecticut] (YSM), Icahn School of Medicine at Mount Sinai [New York] (MSSM), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Fundación Huésped [Buenos Aires], Université Paris Diderot, Sorbonne Paris Cité, Paris, France, Université Paris Diderot - Paris 7 (UPD7), Fundação Oswaldo Cruz (FIOCRUZ), Réseau International des Instituts Pasteur (RIIP), Federal University of Sao Paulo (Unifesp), IRCCS San Raffaele Scientific Institute [Milan, Italie], Georgetown University [Washington] (GU), Orlando Immunology Center, GlaxoSmithKline, Glaxo Smith Kline, GlaxoSmithKline [Research Triangle Park] (GSK ), ViiV Healthcare US, ViiV Healthcare [Brentford, UK], BRIGHTE Trial Team: P Cahn, L Cassetti, D O David, E Loiza, D Cecchini, S Lupo, M Martins, C Zala, A Carr, J McMahon, S De Wit, E Florence, C R Alves, J Andrade Neto, M Della Negra, R Diaz, B Grinsztejn, J Madruga, K Morejon, F Ribeiro, E Sprinz, M Murray, J Szabo, S Trottier, S Walmsley, J Ballesteros, F Zamora, C Beltran, C Chahin Anania, C Perez, M Wolff Reyes, J Velez, P M Girard, C Katlama, J-M Molina, D Neau, G Pialoux, I Poizot-Martin, F Raffi, D Salmon-Ceron, K Arastéh, A Baumgarten, J Bogner, M Hower, W Kern, D Schürmann, C Stephan, S Metallidis, V Paparizos, P Mallon, A Antinori, R Cauda, A Lazzarin, G Migliorino, C Mussini, G Orofino, G Rizzardini, P F Belaunzaran, R Cabello, J Duque Rodríguez, M Santoscoy-Gómez, S C Treviño, I Hoepelman, F Mendo, Y Pinedo Ramirez, M Parczewski, B Knysz, N Janeiro, F Maltez, L Preotescu, A Streinu-Cercel, G Latiff, I Mitha, J M Libre Codina, S Moreno Guillén, J Pineda, S M Hsieh, A Pozniak, J Aberg, J Bartczak, M Berhe, T Campbell, C Creticos, E DeJesus, V Drelichman, C Durand, J Eron, C Fichtenbaum, R Grossberg, S Gupta, F Haas, D Hagins, M Jain, M Kozal, P Kumar, J Lalezari, J Lennox, R Loftus, R Lubelchek, J McGowan, M McKellar, A Mills, J Morales-Ramirez, O Osiyemi, N Ramgopal, S Schrader, J Slim, P Tebas, M Thompson, W Towner, T Wilkin, A Wurcel, Malbec, Odile, Kozal, M., Aberg, J., Pialoux, G., Cahn, P., Thompson, M., Molina, J. -M., Grinsztejn, B., Diaz, R., Castagna, A., Kumar, P., Latiff, G., Dejesus, E., Gummel, M., Gartland, M., Pierce, A., Ackerman, P., Llamoso, C., Lataillade, M., Yale University School of Medicine, and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
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Adult ,Male ,[SDV]Life Sciences [q-bio] ,Human immunodeficiency virus (HIV) ,HIV Infections ,Drug resistance ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Piperazines ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Drug Resistance, Multiple, Viral ,Randomized controlled trial ,law ,Humans ,Medicine ,Prodrugs ,030212 general & internal medicine ,Aged ,business.industry ,General Medicine ,Middle Aged ,Viral Load ,Virology ,Organophosphates ,CD4 Lymphocyte Count ,3. Good health ,[SDV] Life Sciences [q-bio] ,Clinical trial ,Multiple drug resistance ,Fostemsavir ,Anti-Retroviral Agents ,Multicenter study ,HIV-1 ,RNA, Viral ,Drug Therapy, Combination ,Female ,business - Abstract
International audience; Background: Among some patients with human immunodeficiency virus type 1 (HIV-1) infection who have undergone multiple antiretroviral therapies and have limited options for treatment, new classes of antiretroviral drugs with novel mechanisms of action are needed. Fostemsavir is the prodrug of temsavir, a first-in-class investigational HIV-1 attachment inhibitor.Methods: In this ongoing phase 3 trial in 23 countries, we enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to their remaining treatment options. In the first cohort, we assigned (in a 3:1 ratio) patients who had the option of using at least one fully active, approved antiretroviral drug in at least one but no more than two antiretroviral classes to add either fostemsavir (at a dose of 600 mg twice daily) or placebo to their failing regimen for 8 days, followed by open-label fostemsavir plus optimized background therapy (randomized cohort). In the second cohort, patients who had no remaining antiretroviral options were started on open-label fostemsavir plus optimized background therapy on day 1 (nonrandomized cohort). The primary end point was the mean change in the HIV-1 RNA level from day 1 through day 8 in the randomized cohort.Results: A total of 371 patients were treated, including 272 in the randomized cohort and 99 in the nonrandomized cohort. At day 8, the mean decrease in the HIV-1 RNA level was 0.79 log10 copies per milliliter in the fostemsavir group and 0.17 log10 copies in the placebo group (P
- Published
- 2020
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