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.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health