MTN-039 was a Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir is a potent inhibitor of HIV-1 integrase. TAF is a nucleotide reverse transcriptase inhibitor and a prodrug of tenofovir. The study enrolled 23 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age and older who have a history of consensual receptive anal intercourse (RAI). Participants received a single TAF/EVG (20 mg/16 mg) insert rectally, and samples were collected over a three-day period. Following a washout period, participants applied two TAF/EVG inserts rectally, with samples being collected over a three-day period. It is hypothesized that one TAF/EVG insert and two TAF/EVG inserts will be safe and well-tolerated among healthy men and women, when a single dose of either study product is administered rectally under direct observation in the clinic.
The study completed follow-up on April 7, 2021. Data cleaning is currently in progress.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health