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:
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Safety
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To evaluate the safety of the TAF/EVG Insert, 20/16 mg administered rectally at two dose levels: 1 insert and 2 inserts
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- 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:
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Acceptability
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To identify product attributes considered likely to challenge and/or facilitate future sustained use of the TAF/EVG Insert applied rectally
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Exploratory Objectives:
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Ex Vivo Efficacy
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To assess the preliminary (ex vivo) efficacy of TAF/EVG after product is inserted rectally
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Pharmacokinetics
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To characterize the cervicovaginal pharmacokinetics of the TAF/EVG Insert, 20/16 mg applied rectally at two dose levels: 1 insert and 2 inserts
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- Mucosal Safety
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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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