Microbicide Trials Network

MTN-029/IPM 039

Details

Protocol Title: 
Phase 1 Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
DAIDS Protocol ID: 
12036
Status: 
Closed to Accrual

Protocol Chair(s)

Richard Beigi (Protocol Co-Chair)
Lisa Noguchi (Protocol Chair)

Description

MTN-029/IPM 039 is a Phase I, open-label, multi-site study that is designed to assess the presence of dapivirine in breast milk when delivered via a silicone elastomer vaginal matrix ring containing dapivirine (25 mg) when used continuously for 14 days. The primary objective of this trial is to assess the pharmacokinetics (PK) of the dapivirine ring. The trial will also evaluate safety and tolerability, as well as adherence to the ring, when used for 14 consecutive days by lactating women.  The study will enroll approximately 16 healthy, HIV-negative women ages 18 years and older, at least 6 weeks postpartum, who are lactating but not breastfeeding, at two U.S. sites.  Each participant will wear the VR continuously for approximately 2 weeks. It is anticipated that this study will require approximately 12-18 months to conduct.

Other Study Info

Sponsor:

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 

Co-Sponsor:

IPM 

Study Design:

Phase I, multi-site, open-label trial