MTN-043

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 24^th International AIDS Conference held on July 29-August 2, 2022, in Montreal, Canada.