- Assess safety of dapivirine (25 mg) administered via silicone vaginal ring (VR) in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24 weeks of study product use
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females; 15-17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or placebo VR. Each participant was followed for approximately 25 weeks (24 weeks on study product and a final phone call one week after end of study product use). Secondary objectives of the trial included evaluating acceptability and adherence to a dapivirine (25 mg) VR when inserted once every 4 weeks for a 24-week period in HIV uninfected adolescent females, and to evaluate local and systemic dapivirine exposure.
The dapivirine (25 mg) VR was evaluated in ASPIRE and other studies in women who are 18 to 40 years of age. The FDA requested additional safety data in adolescent females and MTN-023/IPM 030 along with MTN-034 provided safety and acceptability data in adolescent females. This study was a collaborative effort between the MTN and the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
MTN-023/IPM 030 completed follow-up on July 5, 2016. Primary results were presented at the International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment & Prevention, held on July 23-26, 2017, in Paris, France. The primary manuscript was published in Journal of Acquired Immune Deficiency Syndromes on February 1, 2020. A total of four papers have been published from this study.
Dapivirine VRs were safe and found to be acceptable in adolescent females in the U.S. The mean age of the 96 enrolled participants was 16.3 years; 59% were black and 34% white. Adherence to study visits was 97%. There were no differences in safety outcomes between treatment arms. By self-report, 42% (95% CI 32, 52) of participants reported that they never removed the ring except to replace it monthly. In the dapivirine group, drug levels indicated adherence in 87% of plasma samples and 95% of used rings. Participants noted no discomfort due to the ring at 87% of visits and “liking” the ring at 93% of visits. The most frequently cited concern (28%) involved their primary sex partner feeling the ring during sex.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health