Phase 2 study of the safety and tolerability of maraviroc-containing regimens to prevent HIV infection in men who have sex with men (HPTN 069/ACTG A5305)

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. SalataManya Magnus, Jason E. Farley, Albert Liu, Ian Frank, Ken Ho, Jorge Santana, Joanne D. Stekler, Marybeth McCauley, Kenneth H. Mayer

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)238-246
Number of pages9
JournalJournal of Infectious Diseases
Volume215
Issue number2
DOIs
StatePublished - Jan 15 2017

Keywords

  • HIV
  • Maraviroc
  • Men who have sex with men (MSM)
  • Phase 2 clinical trial002E
  • PrEP

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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