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 will provide safety and acceptability data in adolescent females. 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.
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).
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health