A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF), or Tenofovir disoproxil fumarate + Emtricitabine (TDF+FTC) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men and in At-Risk Women
What is HPTN 069?
HPTN 069/ACTG 5305 was a study to learn more about the safety and acceptability of oral maraviroc in at risk HIV uninfected men who have sex with men (MSM) and in at-risk HIV uninfected women.
Who participated in the study?
406 MSM and 188 women were enrolled at 13 sites in the United States and Puerto Rico.
What happened during the study?
Study participants were randomly assigned to one of four arms: once-daily maraviroc alone, maraviroc plus TDF, maraviroc plus emtricitabine, or TDF and emtricitabine (FTC). The study participants and the study researchers were blinded to the study arm randomizations.
The study was an important next step in helping to determine if future research should be done to see if maraviroc-containing regimens can be used as PrEP. There are some concerns about the possibility of side effects and resistance related to the antiretrovirals (ARVs)that are currently used for PrEP. Resistance means that some strains of HIV can no longer be treated with certain ARVs. Maraviroc is an approved drug that blocks entry of HIV into cells, and is also not widely used for treatment. It has been shown to be safe for use by HIV-infectedpeople and rarely causes drug resistance.
The results for the men’s cohort found that the maraviroc-containing regimens were as safe and well-tolerated as TDF/FTC. Five participants became infected with HIV in the men’s cohort. These participants had low, variable or undetectable drug levels, likely indicating they were not consistently taking their pills
The researchers also reported results from a substudy evaluating the impact of these regimens on colorectal tissue samples from 55 participants. Previous work in HIV-infected people had suggested that maraviroc may increase immune T-cell activation in rectal tissue, which potentially could increase susceptibility to HIV infection. However, the researchers did not observe increased T-cell activation in the samples. Viral suppression experiments with tissue samples taken from study participants provided a preliminary indication that maraviroc alone may be less effective at preventing HIV infection than combination PrEP regimens.
The women’s cohort primary results were presented at AIDS 2016 in Durban, South Africa.
HPTN 069 Version 3.0
- HPTN 069 Version 3.0 (03 Jan 2013)
- LOA #5 (24 Feb 2015)
- LOA #4 (14 Jul 2014)
- LOA #3 (5 Mar 2014)
- LOA #2 (1 Jul 2013)
- LOA #1 (24 May 2013)
- V3 Clarification Memo #1 (13 Jan 2014)
HPTN 069 Version 2.0