MTN-024/IPM 031

MTN-024/IPM 031 was a multi-center, two-arm, randomized, double blind, placebo-controlled Phase 2a trial.  The study enrolled 96 healthy, HIV-uninfected, post-menopausal females, 45-65 (inclusive) years of age.  They were randomized in a 3:1 ratio to one of the following study groups: placebo VR or dapivirine (25 mg) VR.  Each enrolled participant was followed for approximately 13 weeks (12 weeks on study product and a final phone call one week after end of study product use). In addition to the primary objective stated above, the MTN-024/IPM 031 trial will evaluate additional secondary objectives including acceptability of and adherence to a dapivirine (25 mg) VR when inserted once every 4 weeks for a 12 week period in HIV uninfected postmenopausal women, as well as local and systemic dapivirine exposure.

The dapivirine (25 mg) VR was evaluated in ASPIRE and other studies in women who are 18 to 45 years of age. MTN-024/IPM 031 filled a gap in the dapivirine VR research portfolio, by providing the necessary safety and acceptability data in sexually active, postmenopausal females. Primary results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held on February 22-25, 2016 in Boston, MA.The primary manuscript was published in Clinical Infectious Diseases on March 19, 2019.

Protocol Chair(s)
Chen, Beatrice (Protocol Chair)
Protocol Title
Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Post-Menopausal Female Population
DAIDS Protocol ID
11915
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
Post Menopause  
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

Source URL: https://www.mtnstopshiv.org/research/studies/mtn-024ipm-031