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MTN-043 is an open label, multi-site, mother-infant pair PK study designed to assess the PK of the dapivirine VR when used during breastfeeding. 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.

Protocol Title
Open Label, Pharmacokinetic, Mother-infant Pair Study of Dapivirine Vaginal Ring Use in Breastfeeding
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
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Infants
Lactating  
Women (cisgender women, non‐transgender women)