MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).
The primary objectives of MTN-034 are to collect safety and adherence data for these two study products in an adolescent population and to provide important information regarding individual preference for the products. This trial enrolled 247 healthy, HIV-uninfected, adolescent females. Participants were randomized (1:1) to one of two study product application sequences: (a) daily FTC/TDF oral tablets for 24 weeks, followed by use of the dapivirine VR inserted monthly for 24 weeks; or (b) monthly dapivirine VR for 24 weeks, followed by daily FTC/TDF oral tablets for 24 weeks. After completing the randomized sequence of two study product use periods, participants then selected one of the study products (or neither) to use in the third and final 24 weeks of the trial. In total, participants will be followed up for approximately one and a half years. Participants could choose either or neither study product at any time during the third product use period.
The study was closed to accrual on May 28, 2020. Study follow-up is expected to complete in October 2021.
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