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MTN-043 is an open label, multi-site, randomized (3:1 to VR:tablet), mother-infant pair study designed to assess the safety and drug detection of the dapivirine VR and FTC/TDF oral tablet when used during breastfeeding. Approximately 200 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.

Protocol Title
Phase 3B, Open-label, Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Status
In Development
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