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MTN-039 was ad 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.

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
38470
Status
Closed to Follow Up
Formulation
Rectal Insert
Drug
Elvitegravir
Tenofovir   
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender men
Transgender women
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
DAIDS