MTN-039

Primary Objectives

• To evaluate the safety of an insert containing TAF/EVG administered rectally
• To characterize the systemic and rectal pharmacokinetics of the insert containing TAF/EVG administered rectally

Study Summary
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. TAF is a nucleotide reverse transcriptase inhibitor and a prodrug of tenofovir and EVG is an integrase inhibitor. The study enrolled 23 healthy, HIV-uninfected individuals 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. Database was locked on July 21, 2021. Study results are expected in March 2022.