Microbicide Trials Network

MTN-023/IPM 030

Details

Protocol Title: 
Phase 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females
DAIDS Protocol ID: 
11927
Status: 
Closed to Follow Up

Protocol Chair(s)

Katherine Bunge (Protocol Co-Chair)
Kathleen Squires (Protocol Chair)

Description

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).

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