Microbicide Trials Network

MTN-024/IPM 031

Details

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

Protocol Chair(s)

Beatrice Chen (Protocol Chair)

Description

MTN-024/IPM 031 is 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 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 post-menopausal women.  MTN-024/IPM 031 will fill a void in the dapivirine VR research portfolio, by providing the necessary safety and acceptability data in sexually-active, postmenopausal females.

Other Study Info

Sponsors:

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

IND Sponsor:

International Partnership for Microbicides