MTN-029/IPM 039

MTN-029/IPM 039 was a Phase I, open-label study that was designed to assess the presence of dapivirine in blood, breast milk, and cervicovaginal fluid when delivered via a vaginal ring used continuously for 14 days. The trial also evaluated the safety and tolerability of the dapivirine vaginal ring when used for 14 consecutive days as well as adherence to the dapivirine vaginal ring in lactating women. The study enrolled 16 healthy, HIV-negative women, aged 18 years or older, at least 6 weeks postpartum, who were lactating but not breastfeeding, at two U.S. sites.

The study completed follow-up on March 3, 2017. Primary results were presented at the International AIDS Society (IAS) HIV Pathogenesis, Treatment & Prevention meeting, July 23- 26, 2017, in Paris, France and at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) meeting held on Aug 10-12, 2017 in Park City, UT. The primary manuscript was published in Antimicrobial Agents and Chemotherapy on February 26, 2019.

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


Source URL: https://mtnstopshiv.org/research/studies/mtn-029ipm-039