MTN 029/ IPM 039

Principal Investigator(s):Craig Hoesley, MD
Objective: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.
Prevention Option(s):Microbicides
Study Design:Open label
Arms and Assigned Interventions
DescriptionA dapivirine vaginal ring will be inserted in Healthy lactating women, 18 years or older at screening, at least 6 weeks postpartum, who are able to produce breast milk but who are not breastfeeding. The dapivirine vaginal ring will be worn for 14 consecutive days.
Mode of DeliveryRing
Official Code: NCT02658227
Trial Sponsors: NIAID, NICHD, NIH, NIMH
Start Date
End Date
February 2, 2016
March 3, 2018
Age range: 18 Years ↔ 60 Months
Population:Cisgender Women, People Living with HIV