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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.

Protocol Chair(s)
Beigi, Richard (Protocol Co-Chair)
Noguchi, Lisa (Protocol Chair)
Protocol Title
Phase 1 Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
DAIDS Protocol ID
12036
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Study Focus/Product Administration
Vaginal
Study Type
Pharmacokinetics
Pharmacodynamic
Safety
Study Phase
Phase I  
Countries
United States
Population
Lactating  
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)
IPM
Other Study Info

Phase I, multi-site, open-label trial