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Status
Ongoing
Phase
Open Label
Principal Investigator(s)
Maxensia Owor, MBChB, MMed (Paed), MPH; Lisa Noguchi, PhD, CNM; Jennifer Balkus, PhD, MPH
Objective
The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.
Last updated May 13, 2021
Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Double-blind
Arms and Assigned Interventions
Description
Approximately 100 healthy, HIV-uninfected breastfeeding women and their healthy infants between 6-12 weeks old (inclusive) will be enrolled in MTN-043.
Enrolled maternal participants will be on study product for approximately 12 weeks, and enrolled mother-infant pairs will be followed up for up to three and a half months.
Mode of Delivery
Ring
Products
Dapivirine Ring
Official Code
Trial Sponsors
NIAID (DAIDS-ES: 38591 )
August 2020
March 2021
Enrollment
200
2
Months
Population
Lactating women
Women
Sites
Blantyre CRS
Malawi
Shandukani
South Africa
MU-JHU Research Collaboration CRS
Kampala
Uganda
Zengeza CRS
Harare
Zimbabwe