Current Projects

MTN-039

A Phase 1 open label study of a single dose Elvitegravir insert at two dose levels administered rectally.

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.

Goals

Primary Objectives:

  1. Safety

    • To evaluate the safety of the TAF/EVG Insert, 20/16 mg administered rectally at two dose levels: 1 insert and 2 inserts

  2. Pharmacokinetics
    • To characterize the systemic and rectal pharmacokinetics of the TAF/EVG Insert, 20/16 mg applied rectally at two dose levels: 1 insert and 2 inserts

Secondary Objectives:

  1. Acceptability

    • To identify product attributes considered likely to challenge and/or facilitate future sustained use of the TAF/EVG Insert applied rectally

Exploratory Objectives:

  1. Ex Vivo Efficacy

    • To assess the preliminary (ex vivo) efficacy of TAF/EVG after product is inserted rectally

  2. Pharmacokinetics

    • To characterize the cervicovaginal pharmacokinetics of the TAF/EVG Insert, 20/16 mg applied rectally at two dose levels: 1 insert and 2 inserts

  3. Mucosal Safety
    • To evaluate mucosal safety of the TAF/EVG Insert, 20/16 mg applied rectally at two dose levels: 1 insert and 2 inserts

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