MTN-034/IPM 045, a Phase 2a, multi-site, randomized, open-label, crossover study, will enroll approximately 300 healthy, HIV-uninfected adolescent females between the ages of 16 - 17 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. The primary purpose of this trial is to collect safety and adherence data over the course of study product use. MTN-034/IPM 045 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 49 weeks.
Other Study Info
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Pharmaceutical Company Collaborator: Gilead Sciences, Inc.
Study Design: Phase 2a, randomized, open label, crossover trial