Phase 2 Study of the Safety and Tolerability of Maraviroc-containing Regimens to Prevent Hiv Infection in Men Who Have Sex With Men (msm) (hptn 069/actg A5305)
Year: 2016
Type: article
Abstract: BACKGROUND: Maraviroc (MVC) is a candidate for human immunodeficiency virus (HIV) pre-exposure prophylaxis. METHODS: Phase 2 48-week safety/tolerability study was conducted, comparing 4 regimens: MVC alone, MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. Eligible participants were HIV-uninfected men and transgender women reporting condomless anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. At each visit, assessments, laboratory testing, and counseling were done. Analyses were intention to treat. RESULTS: Among 406 participants, 84% completed follow-up, 7% stopped early, and 9% were lost to follow-up; 9% discontinued their regimen early. The number discontinuing and the time to discontinuation did not differ among study regimens (P = .60). Rates of grade 3-4 adverse events did not differ among regimens (P = .37). In a randomly selected subset, 77% demonstrated detectable drug concentrations at week 48. Five participants acquired HIV infection (4 MVC alone, 1 MVC + TDF; overall annualized incidence, 1.4% [95% confidence interval, .5%-3.3%], without differences by regimen; P = .32); 2 had undetectable drug concentrations at every visit, 2 had low concentrations at the seroconversion visit, and 1 had variable concentrations. CONCLUSIONS: MVC-containing regimens were safe and well tolerated compared with TDF + FTC; this study was not powered for efficacy. Among those acquiring HIV infection, drug concentrations were absent, low, or variable. MVC-containing regimens may warrant further study for pre-exposure prophylaxis. CLINICAL TRIALS REGISTRATION: NCT01505114.
Authors: Roy M. Gulick, Timothy J. Wilkin, Ying Q. Chen, Raphael J. Landovitz, K. Rivet Amico, Alicia M. Young, Paul Richardson, Mark A. Marzinke, Craig W. Hendrix, Susan H. Eshleman, Ian McGowan, Leslie M. Cottle, Adriana Andrade, Cheryl Marcus, Karin L. Klingman, Wairimu Chege, Alex R. Rinehart, James F. Rooney, Philip Andrew, Robert A. Salata, Manya Magnus, Jason E. Farley, Albert Liu, Ian Frank, Ken Ho, Jorge Santana, Joanne D. Stekler, Marybeth McCauley, Kenneth H. Mayer
Institutions: Weill Cornell Medicine, Fred Hutch Cancer Center, University of California, Los Angeles, University of Michigan, Johns Hopkins University, University of Pittsburgh, University of North Carolina at Chapel Hill, National Institutes of Health, National Institute of Allergy and Infectious Diseases, ViiV Healthcare (United Kingdom), Gilead Sciences (United States), Family Health International 360, Case Western Reserve University, George Washington University, San Francisco Department of Public Health, University of Pennsylvania, University of Puerto Rico, Medical Sciences Campus, University of Puerto Rico System, University of Washington, Beth Israel Deaconess Medical Center, Harvard University, Fenway Health
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Bristol-Myers Squibb, GlaxoSmithKline, Gilead Sciences, University of Pennsylvania, George Washington University, University of Michigan, University of Washington, Johns Hopkins University, University of Pittsburgh, West Virginia University, ViiV Healthcare, FHI 360, ACT Government, National Institutes of Health, University of California, Los Angeles, Weill Cornell Medical College, University of North Carolina at Chapel Hill, University of California, San Francisco, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: G1479152345, G1507718124, G174905615, G1852790566, G2507544392, University of Pittsburgh Clinical and Translational Science Institute, G3788978964, G3873853564, North Carolina Translational & Clinical Sciences Institute (NC TraCS), Case Clinical Trials Unit, Integrated University of Puerto Rico Clinical Trials Unit, University of Pittsburgh Clinical and Translational Science Institute, G5768112423, Terry Beirn CPCRA Clinical Trials Unit, G674907753, G7348756, G749807406, G8852914737, Clinical and Translational Science Center (UL1), HIV Prevention Trials Network Leadership and Operations Center, District of Columbia Center for AIDS Research, University of Pennsylvania HIV Clinical Trials Unit, Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), Penn Center for AIDS Research, Johns Hopkins University Baltimore India Clinical Trail Unit (JHUBI CTU), The University of North Carolina Center for AIDS Research, Pitt-Ohio State Clinical Trials Unit, LC: HIV PREVENTION TRIALS NETWORK, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, SDMC: HIV Prevention Trials Network, San Francisco Bay Clinical Trials Unit (CTU), Seattle Clinical Trials Unit, UCLA AIDS Prevention and Treatment Clinical Trials Unit, Boston HIV CTU
OpenAlex ID: W2547061843