The Setpoint Study (ACTG A5217): Effect of Immediate Versus Deferred Antiretroviral Therapy on Virologic Set Point in Recently HIV-1–Infected Individuals
Year: 2011
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: The benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved. METHODS: A5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log(10) HIV-1 RNA level at week 72 (both groups) and 36 (DT group). RESULTS: At the June 2009 Data Safety Monitoring Board (DSMB) review, 130 of 150 targeted participants had enrolled. Efficacy analysis included 79 individuals randomized ≥72 weeks previously. For the primary end point, the IT group at week 72 had a better outcome than the DT group at week 72 (P = .005) and the DT group at week 36 (P = .002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group. The DSMB recommended stopping the study because further follow-up was unlikely to change these findings. CONCLUSIONS: Progression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment. CLINICAL TRIALS REGISTRATION: NCT00090779.
Institutions: Medical College of Wisconsin, Columbia University, Harvard University, University of North Carolina at Chapel Hill, Emory University, University of California, San Francisco, Aaron Diamond AIDS Research Center, Rockefeller University, University of Colorado Denver, University of Pittsburgh, Brown University, Miriam Hospital, Social and Scientific Systems (United States), National Institute of Allergy and Infectious Diseases, University of California, Los Angeles, The Lundquist Institute, Harbor–UCLA Medical Center, University of California San Diego
Language: English
Topic: HIV Research and Treatment
Subfield: Virology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
Funders: Abbott Laboratories, Gilead Sciences, ACT Government, National Institutes of Health, Centers for Disease Control and Prevention, U.S. Public Health Service, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: G1019738922, G1050281965, Units for HIV/AIDS Clinical Trials Networks, G115468880, G1158897216, G1158968046, G1214792496, G1225594167, G1346130624, G1586133245, G1586896293, G1609126075, WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT, G16708505, G1781340182, G183157880, G1939689254, G1944963898, G1976846336, G2069435444, G2127051194, G2135258891, G2199452652, G220748524, G2268686290, G2344635089, G2491380097, G2501702145, G2630776462, G271901027, G2737559749, G2767534537, G2783911642, G286338745, G2936172085, G2987980373, G310026855, G3116536149, G3142995538, G3206931443, General Clinical Research Center, G3483687112, G3525517067, G374818150, UW Clinical HIV Integrated Research Program, G4106925572, G429479147, Immunopathogenesis of Acute HIV-1 Infection, G4632628815, G4649361189, G475936976, G4895815965, G5046654427, G5173677171, G5211237770, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM IN AIDS, G5268332287, UCSD Department of Medicine HIV/AIDS Clinical Trials Unit, G5900455136, G6008919121, G6456522440, G6464879405, G650174051, UNC Clinical and Translational Science Award, G661928818, G6643580741, THE IMPACTA PERU CLINICAL TRIALS UNIT, UCSF HIV Clinical Trials Unit, Atlanta Clinical and Translational Science Institute (KL2), Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, Determinants of HIV Transmission, G7348756, G7401883790, Understanding and Altering the Virologic Setpoint, General Clinical Research Center, G7754564054, G8487837538, G857487509, Institute of Human Virology Clinical Trials Unit, Center for AIDS Research at Emory University, Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), The University of North Carolina Center for AIDS Research, G926868656, ADULT AIDS CLINICAL TRIALS UNIT, G936311976, G961682679, Colorado Clinical and Translational Science Institute (UL1)
OpenAlex ID: W2158564605