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Status
Completed
Phase
Open Label
III
Principal Investigator(s)
Maxensia Owor, MBChB, MMed (Paed), MPH; Lisa Noguchi, PhD, CNM; Jennifer Balkus, PhD, MPH
Objective
MTN 043 is a Phase 3B, randomized, open label trial with 12 weeks exposure to DVR on oral 200mg emtricitabine (FTC)/ 300mg tenofovir disoproxil fumarate (TDF) tablet. 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.
August 2022 update: Follow-up phase was completed in November 2021, and preliminary results were presented AIDS 2022
- 197 mother-infant pairs enrolled (148 on DVR, 49 on oral PrEP)
- Median age of mothers was 29 years and infants was 9 weeks
- No product related SAEs in mothers; No infant AEs related to product for either arm
"Favorable safety profile and previous data demonstrating low drug transfer to breastmilk support updates of WHO and national guidelines to include breastfeeding people when recommending the DVR as an HIV prevention choice"
Last update August 8, 2022
Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Double-blind
Arms and Assigned Interventions
Description
Experimental: Group A: Dapivirine (DPV) Vaginal Ring (VR)-004
Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Experimental: Group B: Truvada Tablet
Mothers will take one Truvada oral tablet daily for approximately three months.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Active Comparator
Official Code
Publication File
Trial Sponsors
NIAID (DAIDS-ES: 38591)
August 2020
November 2021
Date of Enrollment Completion
November 4, 2021
Enrollment
394
2
Months
Population
Adolescent/Children
Lactating women
Women
Sites
Blantyre CRS
Malawi
Shandukani
South Africa
MU-JHU Research Collaboration CRS
Kampala
Uganda
Zengeza CRS
Harare
Zimbabwe