Microbicide Trials Network



Protocol Title: 
A Double Blind Randomized Phase 2A Study of Dapivirine 0.05% Gel Applied Rectally in HIV-1 Seronegative Adults
DAIDS Protocol ID: 
In Development


MTN-035 is a Phase 2A, double blind, randomized clinical trial designed to evaluate the safety and pharmacokinetics of dapivirine gel (DPV; 0.05%) administered rectally using an applicator. Approximately 204 healthy MSM and transgender women who have a history of RAI will be randomized to study product (1:1) to receive DPV or universal HEC placebo gel.  For approximately 6 months, a single dose of study product will be administered via applicator before sex, or at least 3 times per week in the absence of sex.  Participants will be provided oral PrEP in addition to gel. The ideal coital-dosing regimen for DPV gel applied rectally is not yet known. The projected accrual period for this study is approximately 6 months. The study will require approximately 12 months to conduct. About 6 months of follow-up per participant is planned. The final sample size has yet to be determined.

Other Study Info

Sponsor: IPM


Study Design: Phase 2A, double blind, randomized trial