- To assess the pharmacokinetics of dapivirine vaginal ring used for 14 consecutive days in lactating women
MTN-029/IPM 039 was a Phase I, open-label study that was designed to assess the presence of dapivirine in blood, breast milk, and cervicovaginal fluid when delivered via a vaginal ring used continuously for 14 days. The trial also evaluated the safety and tolerability of the dapivirine vaginal ring when used for 14 consecutive days as well as adherence to the dapivirine vaginal ring in lactating women. The study enrolled 16 healthy, HIV-negative women, aged 18 years or older, at least 6 weeks postpartum, who were lactating but not breastfeeding, at two U.S. sites. Each participants wore the ring for about two weeks.
MTN-029/IPM 039 completed follow-up on March 3, 2017. Primary results were presented at the International AIDS Society (IAS) HIV Pathogenesis, Treatment & Prevention meeting held on July 23-26, 2017, in Paris, France and at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) meeting held on Aug 10-12, 2017, in Park City, Utah. The primary manuscript was published in Antimicrobial Agents and Chemotherapy on February 26, 2019. A total of two papers have been published from this study.
Dapivirine concentrations were detectable in milk and plasma in all participants at all tested time points (except for one participant with undetectable plasma levels at the 3-hour post insertion time point). Median dapivirine peak concentration were 676 pg/mL in breast milk, 327 pg/mL in plasma (milk: plasma ratio ∼2.0), and 36.25 ng/mg in CVF. The estimated mean daily infant intake was low, at 74.3 ng/kg/day or for an 8 kg infant (median weight for male infant at ~6 months old), at approximately 594.4 ng/day (<1 μg/day). Six of 16 (38%) participants experienced a total of ten AEs, most of which were mild and unrelated to study product. In summary, dapivirine vaginal ring use was associated with low concentrations of detectable dapivirine in milk and plasma and a favorable safety profile in lactating women.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Phase I, multi-site, open-label trial