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MTN 043

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
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