MTN-017

MTN-017 was a Phase 2, multi-site, six-sequence, three-period, open-label, crossover, randomized study examining the effects of oral FTC/TDF (Truvada®) and RG tenofovir 1% gel used as a rectal microbicide. The study enrolled 195 sexually active, HIV-uninfected males or transgender women (TGW) at least 18 years of age who also reported a history of RAI in the past three months. Participants were randomized equally across the 6 sequences and followed for approximately 27 weeks (>6 months). Study product use periods included three 8-week sessions with 1-week washout periods between each. One week following the third 8-week session, a follow-up visit occurred. To assess acceptability, participants self-reported ease of use, liking the product, and likelihood of product use if shown to be effective. Each of the study product regimens offered different advantages to participants seeking an effective HIV prevention agent, and this study examined how these relative advantages compared in terms of safety, acceptability, systemic and local absorption, and adherence. Primary results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) held on February 22-25, 2016 in Boston, MA. The primary manuscript was published in Clinical Infectious Diseases on March 1, 2017.

Protocol Chair(s)
Cranston, Ross (Protocol Chair)
Lama, Javier (Protocol Co-Chair)
Protocol Title
A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel.
DAIDS Protocol ID
11857
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Oral Tablet
Drug
Tenofovir   
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase II
Countries
Peru
South Africa
Thailand
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender women
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
CONRAD
Gilead Sciences, Inc.

Source URL: https://www.mtnstopshiv.org/research/studies/mtn-017