MTN-017

MTN-017 is a Phase 2, multi-site, six-sequence, three-period, open label, crossover, randomized study examining the effects of oral FTC/TDF (Truvada^®) and tenofovir RG 1% gel used as a rectal microbicide  (as shown in the table below). The study enrolled 195 sexually active, HIV-uninfected males or transgender females at least 18 years of age who also report a history of RAI in the past 3 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 occurs. 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 offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages compare in terms of safety, acceptability, systemic and local absorption, and adherence is being examined within this study.