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Primary Objectives

  • To describe the maternal safety profile associated with study product exposure during breastfeeding in both study arms.
  • To describe the infant safety profile associated with study product exposure during breastfeeding in both study arms.
  • To summarize the frequency of study drug detection and concentration of study drug(s) in mothers and their breastfeeding infants.

Study Summary
MTN-043 was a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the dapivirine VR (25 mg), inserted every 4-weeks, and once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding. The study enrolled 197 healthy, HIV-uninfected breastfeeding women and their healthy infants between 6-12 weeks old (inclusive). Mother-infant pairs were randomized to the study products in a 3:1 ratio (VR: tablet). For mothers randomized to the DPV VR, the VR was worn continuously for approximately one month (4 weeks) and replaced monthly (4 weeks) for approximately three months (12 weeks). Mothers using Truvada tablet took one tablet by mouth daily for approximately three months (12 weeks). Enrolled mother-infant pairs were followed up for up to three and a half months. In addition to the primary objectives, the study also evaluated adherence to and acceptability of the two study products.

MTN-043 completed study follow-up on November 4, 2021. Database was locked on March 11, 2022. Interim primary safety results were presented at the 24th International AIDS Conference held on July 29-August 2, 2022, in Montreal, Canada.

Protocol Chair(s)
Balkus, Jen (Protocol Co-Chair)
Noguchi, Lisa (Protocol Co-Chair)
Owor, Maxensia (Protocol Chair)
Protocol Title
Phase 3B, Open-label, Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Status
Participants off Study and Primary Analysis Completed
Formulation
Oral Tablet
Vaginal Ring
Drug
Dapivirine
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase IIIB
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Infants
Lactating  
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
DAIDS