Breast milk dapivirine pharmacokinetics, estimated infant exposure, and safety during dapivirine intravaginal ring use among lactating women

Abstract

The 25 mg dapivirine (DPV) vaginal ring (VR) can reduce women’s risk of acquiring HIV infection. Most studies of investigational HIV prevention products exclude lactating women, despite global recommendations for breastfeeding and continued risk for HIV acquisition during lactation. MTN-029/IPM 039 was a Phase I, open-label study designed to measure DPV in breast milk and plasma; safety and tolerability; and adherence associated with DPV VR use.