MTN-026 & MTN-033 Rectal Dapivirine Gel

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Presentation transcript:

MTN-026 & MTN-033 Rectal Dapivirine Gel Ken Ho, MD, MPH University of Pittsburgh Clinical Trials Unit

Dapivirine Dapivirine is a molecule that has activity against many types of HIV NNRTI (non nucleoside reverse transcriptase inhibitor) Compounded into a gel with HEC (hydroxyethylcellulose), thickening agents to create 0.05% dapivirine gel

Why Dapivirine? Dapivirine preparations have been studied Safety and Efficacy of vaginal dapivirine ring Minimal systemic levels when use as a microbicide Not used clinically in treatment of HIV Standard treatment gravitating towards use of INSTI based regimens (integrase strand transfer inhibitors)

MTN-026 Phase 1 Pharmacokinetic study of 0.05% rectal dapivirine gel 27 HIV uninfected men/women (cis+trans) 3 sites (Pittsburgh, UAB, Bangkok) Safety, acceptability, drug concentration, tissue infectivity

MTN-033 Phase 1 pharmacokinetic study of dapivirine gel in 16 HIV uninfected cis M + trans W Single site Primary Objective: PK Secondary Objective Safety & Acceptability Exploratory Tissue infectivity Mucosal safety

Not So Sexy?

Sexy

Kind of Like Sexy: Coital Simulation Device

MTN-033 Schema/Study Schedule

Timelines Currently ~60% enrolled Anticipate that the study will be fully enrolled by November 2018 Results summer 2019?

Thank You!