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MTN-039 is an 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. Approximately 20 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) will be enrolled in MTN-039. Participants will receive a single TAF/EVG (20 mg/16 mg) insert rectally, and samples will be collected over a three-day period.  Following a washout period, participants will apply two TAF/EVG inserts rectally, with samples being collected over a three-day period. It is anticipated that this study will take approximately 6-8 months to enroll the target sample size, and that total study duration for participants will be between 6-13 weeks. 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.

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
In Development
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