DELIVER trial to test dapivirine ring, PrEP for safety in pregnant women
The NIH announced the start of the first clinical trial designed specifically to test the safety of the monthly dapivirine vaginal ring in pregnant women. The study also will test the safety of an oral tablet for HIV pre-exposure prophylaxis, or PrEP, in pregnant women.
“Women need reliable HIV prevention methods that they know are safe during pregnancy for themselves and their babies,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a news release. “This new clinical trial will provide important data on the safety of PrEP and the dapivirine ring during pregnancy and will help expectant parents make well-informed HIV prevention choices.”
The trial, a phase 3b safety study, will be conducted at four sites in Malawi, South Africa, Uganda and Zimbabwe using PrEP and dapivirine rings donated by Gilead Sciences and the International Partnership for Microbicides, respectively.
According to the news release, DELIVER researchers plan to enroll 750 healthy, HIV-negative women aged 18 to 40 years who have an uncomplicated pregnancy who will be randomly assigned to receive the dapivirine vaginal ring or PrEP in a 2-to-1 ratio. The participants will use the assigned product until the end of their pregnancy or 42 weeks’ gestation. The trial also will assess the acceptability of the prevention methods among the participants.
Initially, 150 women will be enrolled using their product at 36 to 34 weeks’ gestation. The process will then be repeated with 150 women at 30 to 35 weeks’ gestation, 150 women at 20 to 29 weeks’ gestation and 300 women at 12 to 19 weeks’ gestation, depending upon initial safety assessments.
According to the release, the study team will record any medical problems among the women and infants, and birth defects in the infants, while also tracking the frequency of full-term live births, premature live births and pregnancy losses.
Previous findings from the HOPE trial, an open-label study that offered the vaginal ring to 1,456 HIV uninfected women, found that it reduces the risk for HIV infection by an estimated 39%. These women were also part of the ASPIRE trial, which showed that the dapivirine ring was well tolerated and reduced the incidence of HIV by approximately 27% compared with placebo.
NIH said data from the DELIVER trial may help some countries decide whether and how to roll out PrEP and dapivirine rings — depending on the receipt of regulatory approval —among pregnant women. – by Caitlyn Stulpin
Disclosure: Fauci reports no relevant financial disclosures.
Reference: NIH. NIH-funded clinical trial to test PrEP, dapivirine ring for safety in pregnant women. https://www.nih.gov/news-events/news-releases/nih-funded-clinical-trial-test-prep-dapivirine-ring-safety-pregnant-women. Accessed on February 17, 2020.