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)

J Infect Dis. 2017 Jan 15;215(2):238-246. doi: 10.1093/infdis/jiw525.


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.

Keywords: HIV; PrEP; maraviroc; men who have sex with men (MSM); phase 2 clinical trial.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • CCR5 Receptor Antagonists / administration & dosage*
  • CCR5 Receptor Antagonists / adverse effects*
  • Cyclohexanes / administration & dosage*
  • Cyclohexanes / adverse effects*
  • Disease Transmission, Infectious / prevention & control*
  • Double-Blind Method
  • HIV Infections / prevention & control*
  • Homosexuality, Male
  • Humans
  • Male
  • Maraviroc
  • Middle Aged
  • Pre-Exposure Prophylaxis / methods*
  • Prospective Studies
  • Triazoles / administration & dosage*
  • Triazoles / adverse effects*
  • Young Adult


  • Anti-HIV Agents
  • CCR5 Receptor Antagonists
  • Cyclohexanes
  • Triazoles
  • Maraviroc

Associated data