Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Summary

The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.

Timeline

Start

2020-09-24

Primary completion

2021-11-04

Completion

2021-11-04

Publications

• Noguchi LM, Owor M, Mgodi NM, Gati Mirembe B, Dadabhai S, Horne E, Gundacker H, Richardson BA, Bunge K, Scheckter R, Song M, Marzinke MA, Anderson PL, Livant E, Jacobson C, Piper JM, Chakhtoura N, Hillier SL, Balkus JE; MTN-043 Study Team. Safety and drug quantification of the dapivirine vaginal ring and oral pre-exposure prophylaxis in breastfeeding mother-infant pairs (MTN-043): a phase 3B, open-label, randomised trial. Lancet HIV. 2025 Mar;12(3):e180-e190. doi: 10.1016/S2352-3018(24)00306-0. Epub 2025 Feb 12.

Drugs

Indications