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

2. 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

3. 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)

4. 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

5. 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

6. Not So Sexy?

7. Sexy

8. Kind of Like Sexy: Coital Simulation Device

9. MTN-033 Schema/Study Schedule

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

11. Thank You!