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). Academic Article uri icon



  • 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.


  • Gulick, Roy M
  • Wilkin, Timothy
  • Chen, Ying Q
  • Landovitz, Raphael J
  • Amico, K Rivet
  • Young, Alicia M
  • Richardson, Paul
  • Marzinke, Mark A
  • Hendrix, Craig W
  • Eshleman, Susan H
  • McGowan, Ian
  • Cottle, Leslie M
  • Andrade, Adriana
  • Marcus, Cheryl
  • Klingman, Karin L
  • Chege, Wairimu
  • Rinehart, Alex R
  • Rooney, James F
  • Andrew, Philip
  • Salata, Robert A
  • Magnus, Manya
  • Farley, Jason E
  • Liu, Albert
  • Frank, Ian
  • Ho, Ken
  • Santana, Jorge
  • Stekler, Joanne D
  • McCauley, Marybeth
  • Mayer, Kenneth H

publication date

  • January 15, 2017



  • CCR5 Receptor Antagonists
  • Cyclohexanes
  • Disease Transmission, Infectious
  • HIV Infections
  • Pre-Exposure Prophylaxis
  • Triazoles


PubMed Central ID

  • PMC5790146

Scopus Document Identifier

  • 85021857427

Digital Object Identifier (DOI)

  • 10.1093/infdis/jiw525

PubMed ID

  • 27811319

Additional Document Info


  • 215


  • 2