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MTN-023/IPM 030 is 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 will be 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 include 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 is currently being evaluated in ASPIRE and other studies in women who are 18 to 40 years of age.  The FDA has requested additional safety data in adolescent females. MTN-023/IPM 030 will fill a void in the dapivirine VR research portfolio, by providing the necessary safety and acceptability data in adolescent females.

This study is 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).

Protocol Chair(s)
Bunge, Katherine (Protocol Co-Chair)
Squires, Kathleen (Protocol Chair)
Protocol Title
Phase 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females
DAIDS Protocol ID
11927
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Placebo
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Safety
Study Phase
Phase IIA
Countries
United States
Population
Adolescents
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
International Partnership for Microbicides