MTN-034, a Phase 2a, multi-site, randomized, open-label, crossover study, will enroll approximately 300 healthy, HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). Participants will be randomized to product sequence and will use a silicone elastomer vaginal matrix ring (VR) containing 25 mg of dapivirine (DPV) to be replaced each month for a total period of 6 months of use, as well as take oral emtricitabine/tenofovir (FTC/TDF) tablets daily for a 6 month product use period, and then complete a final 6-month period in which the participant can choose to use the ring, Truvada, or neither. The primary purpose of this trial is to collect safety and adherence data over the course of study product use. MTN-034 will also examine the acceptability of the study products. It is anticipated that this study will take approximately 12 months at each site to enroll the target sample size. Each participant will be followed for approximately 73 weeks.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Gilead Sciences, Inc.
Phase 2a, randomized, open label, crossover trial