| Title: |
Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings |
| Authors: |
Campbell, Thomas B; Smeaton, Laura M; Kumarasamy, N; Flanigan, Timothy; Klingman, Karin L; Firnhaber, Cynthia; Grinsztejn, Beatriz; Hosseinipour, Mina C; Kumwenda, Johnstone; Lalloo, Umesh; Riviere, Cynthia; Sanchez, Jorge; Melo, Marineide; Supparatpinyo, Khuanchai; Tripathy, Srikanth; Martinez, Ana I; Nair, Apsara; Walawander, Ann; Moran, Laura; Chen, Yun; Snowden, Wendy; Rooney, James F; Uy, Jonathan; Schooley, Robert T; De Gruttola, Victor; Hakim, James Gita; Swann, Edith; Barnett, Ronald L; Brizz, Barbara; Delph, Yvette; Gettinger, Nikki; Mitsuyasu, Ronald T; Eshleman, Susan; Safren, Steven; Fiscus, Susan A; Andrade, Adriana; Haas, David W; Amod, Farida; Berthaud, Vladimir; Bollinger, Robert C; Bryson, Yvonne; Celentano, David; Chilongozi, David; Cohen, Myron; Collier, Ann C; Currier, Judith Silverstein; Cu-Uvin, Susan; Eron, Joseph; Flexner, Charles; Gallant, Joel E; Gulick, Roy M; Hammer, Scott M; Hoffman, Irving; Kazembe, Peter; Kumwenda, Newton; Lama, Javier R; Lawrence, Jody; Maponga, Chiedza; Martinson, Francis; Mayer, Kenneth; Nielsen, Karin; Pendame, Richard B; Ramratnam, Bharat; Sanne, Ian; Severe, Patrice; Sirisanthana, Thira; Solomon, Suniti; Tabet, Steve; Taha, Taha; van der Horst, Charles; Wanke, Christine; Gormley, Joan; Marcus, Cheryl J; Putnam, Beverly; Loeliger, Edde; Pappa, Keith A; Webb, Nancy; Shugarts, David L; Winters, Mark A; Descallar, Renard S; Steele, Joseph; Wulfsohn, Michael; Said, Farideh; Chen, Yue; Martin, John C; Bischofberger, Norbert; Cheng, Andrew; Jaffe, Howard; Sharma, Jabin; Poongulali, S; Cardoso, Sandra Wagner; Faria, Deise Lucia; Berendes, Sima; Burke, Kelly; Mngqibisa, Rosie; Kanyama, Cecelia; Kayoyo, Virginia; Samaneka, Wadzanai P; Chisada, Anthony; Faesen, Sharla |
| Contributors: |
Deeks, Steven G |
| Source: |
PLOS Medicine, vol 9, iss 8 |
| Publisher Information: |
eScholarship, University of California |
| Publication Year: |
2012 |
| Collection: |
University of California: eScholarship |
| Subject Terms: |
32 Biomedical and Clinical Sciences (for-2020); 3202 Clinical Sciences (for-2020); Patient Safety (rcdc); Clinical Trials and Supportive Activities (rcdc); Infectious Diseases (rcdc); Sexually Transmitted Infections (rcdc); Clinical Research (rcdc); HIV/AIDS (rcdc); 6.1 Pharmaceuticals (hrcs-rac); Infection (hrcs-hc); Anti-HIV Agents (mesh); Antiretroviral Therapy; Highly Active (mesh); Coinfection (mesh); Drug Therapy; Combination (mesh); Female (mesh); Follow-Up Studies (mesh); HIV Infections (mesh); HIV-1 (mesh); Humans (mesh); Internationality (mesh); Male (mesh); Mycobacterium tuberculosis (mesh); Pregnancy (mesh); Time Factors (mesh); Treatment Outcome (mesh); Withholding Treatment (mesh); PEARLS study team of the ACTG |
| Description: |
BACKGROUND: Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world. METHODS AND FINDINGS: 1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; p |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
qt2z035023; https://escholarship.org/uc/item/2z035023; https://escholarship.org/content/qt2z035023/qt2z035023.pdf |
| DOI: |
10.1371/journal.pmed.1001290 |
| Availability: |
https://escholarship.org/uc/item/2z035023; https://escholarship.org/content/qt2z035023/qt2z035023.pdf; https://doi.org/10.1371/journal.pmed.1001290 |
| Rights: |
https://creativecommons.org/publicdomain/zero/1.0/ |
| Accession Number: |
edsbas.FEC3A019 |
| Database: |
BASE |