Study Title: Phase 3B, Open-label, Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Protocol summary:
MTN-043 is 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 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries 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. The primary objectives are to describe the maternal and infant safety profile associated with study product exposure during breastfeeding in both study arms. The study will also investigate the adherence to and acceptability of open-label use of both products in breastfeeding women. 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.
Location: Zengeza CRS
MTN
Current Study
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