Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Summary

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Timeline

Start

2020-01-09

Primary completion

2024-05-13

Completion

2024-05-13

Publications

• Mhlanga FG, Szydlo DW, Mayo AJ, Bunge K, Fairlie L, Nakabiito C, Musara P, Mgodi NM, Dadabhai S, Scheckter R, Anderson PL, Marzinke MA, Chappell C, Gadama LA, Richardson BA, Piper JM, Hillier SL; MTN-042 DELIVER study team. Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial. Lancet HIV. 2026 Mar;13(3):e176-e184. doi: 10.1016/S2352-3018(25)00307-8. Epub 2026 Feb 10.
• Fairlie L, Szydlo DW, Mayo A, Bunge K, Mhlanga F, Piper J, Dadabhai S, Gatsi VM, Horne E, Ssemambo PK, Mandiwa V, Mgodi NM, Owor M, Anderson PL, Marzinke MA, Nakabiito C, Scheckter R, Chappell C, Hillier SL; MTN-042 study team. Safety outcomes among infants whose mothers used the dapivirine vaginal ring or oral PrEP during pregnancy (MTN-042/DELIVER): a randomised phase 3b study. Lancet HIV. 2025 Nov;12(11):e763-e773. doi: 10.1016/S2352-3018(25)00261-9.
• Nansimbe J, Mirembe BG, Ssemambo PK, Ssekasi AM, Byogero R, Nalwoga J, Nakabiito C. Exploring pregnant women's experiences with dapivirine vaginal ring insertion during the MTN-042/DELIVER study in Uganda: a description of secondary data. Ther Adv Infect Dis. 2025 Apr 11;12:20499361251332750. doi: 10.1177/20499361251332750. eCollection 2025 Jan-Dec.

Drugs

Indications