Email Updates

You are here

Home

MTN 029/ IPM 039

Status
Completed
Phase
I
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
Description
A 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 Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Results
Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring
Official Code
NCT02658227
Trial Sponsors
NIAID, NICHD, NIMH, NIH
February 2016
March 2018
Enrollment
16
18
Years
60
Months
Population
HIV positive
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America