Archived from the MTN website before it was taken down.
Primary Objectives
- Compare the safety profiles of Truvada®, daily RG tenofovir 1% gel, and receptive anal intercourse (RAI)-associated RG tenofovir 1% gel
- Evaluate and compare acceptability of Truvada, daily RG tenofovir 1% gel, and RAI-associated RG tenofovir 1% gel
Study Summary
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.
MTN-017 completed follow-up on June 3, 2015. 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 online in Clinical Infectious Diseases on December 13, 2016. A total of 11 papers have been published from this study.
Primary Results
One hundred eighty-seven evaluable participants were recruited from the US (42%), Thailand (29%), Peru (19%), and South Africa (10%) with mean age of 31.1 years (range 18-64). Twelve percent were transgender women by self-report and 80% had a college education. There were no differences in Grade 2 or higher adverse event rates in participants using daily gel (incidence rate ratio [IRR]: 1.03, p=0.88) or RAI gel (IRR: 0.88, p=0.43) compared to FTC/TDF. High adherence was less likely during the daily gel regimen (odds ratio [OR]: 0.35, p<0.001) and participants reported they would be less likely to use the daily gel regimen for HIV protection compared to FTC/TDF (OR: 0.38, p<0.001). Rectal application of RG TFV gel was safe in men who have sex with men (MSM) and TGW. Adherence use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimen, but lower for the daily gel regimen.
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
Concluded
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.