MTN 043

A Phase 3B randomized, open-label study to assess safety and drug detection of the Dapivirine Vaginal Ring and oral TRUVADA in breastfeeding Mother-Infant Pairs.

Rationale

This study is to assess the safety, drug detection, adherence, and acceptability of the DPV VR (25mg) administered every four weeks, and the once-daily Truvada (200mg FTC/300 mg TDF) tablet used by women from sub-Saharan African countries during breastfeeding. The study aims to enhance our understanding of product safety for both mothers and their breastfeeding infants through the following hypotheses:

• Maternal exposure to the study products will be safe for both mothers and their breastfeeding infants.
• DPV will be detectable at low levels in the breast milk of participant mothers using the VR.
• FTC and TFV will be detectable at low levels in the breast milk of participant mothers taking Truvada.
• DPV will be detectable in the blood of some breastfeeding infants.
• FTC-TP and/or TFV-DP will be detectable in the blood of some breastfeeding infants.

Investigators

• Dr Elizea Horne (Principal Investigator)
• Dr Lee Fairlie (Sub Investigator)
• Dr Faeezah Patel (Sub Investigator)
• Dr Mrinmayee (Sub investigator)

Latest Update

March 2024

For more details about MTN 043 please email rhicomms@wrhi.ac.za

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