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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 soon.

Protocol Chair(s)
Riddler, Sharon (Protocol Chair)
Protocol Title
A Phase 1 Open Label Safety and Pharmacokinetic Study of Single Dose Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels
DAIDS Protocol ID
Closed to Follow Up
Rectal Insert
Study Focus/Product Administration
Study Type
Study Phase
Phase I  
United States
Men (cisgender men, non‐transgender men)   
Transgender men
Transgender women
Women (cisgender women, non‐transgender women)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health