Study of Dapivirine Vaginal Ring (VR) in Adolescents

MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-weeks of study product use. Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 24 week study product use period. Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.