Testing PrEP & Dapivirine Ring for Safety in Pregnant Women
The National Institutes of Health (NIH) announced on February 13, 2020, that it has funded “DELIVER: A Phase 3b Safety Study of the Dapivirine Ring and PrEP in Pregnant Women,” the first clinical trial specifically designed to test the safety of the monthly dapivirine vaginal ring in pregnant women. The study will also assess the safety of a daily oral antiviral tablet for HIV pre-exposure prophylaxis (PrEP) in pregnant women and will assess whether these women accept and use these two HIV prevention tools. The study complements an ongoing NIH-funded trial of PrEP in adolescents and young women during pregnancy and the first six months after birth.
Evidence from earlier clinical trials suggests that PrEP and the dapivirine ring are safe for pregnant women and their fetuses, but the safety of these tools during pregnancy has never yet been tested in a clinical trial designed to assess their safety.
PrEP is already available in some countries and will soon be available in others, while the dapivirine ring is under regulatory review by the European Medicines Agency for potential use in sub-Saharan Africa. Gilead Sciences, Inc., and the International Partnership for Microbicides, which developed the dapivirine ring, are donating PrEP medication and rings for the study.
The DELIVER study team plans to enroll 750 healthy, HIV-negative women aged 18 to 40 years who have an uncomplicated singleton pregnancy. The women will be assigned at random to receive either the dapivirine vaginal ring or PrEP and will be instructed to use their assigned product until the end of their pregnancy. The study team then will enroll the mothers’ newborn infants. They will enroll participants in four stages, with international experts reviewing each completed stage to assess its safety before proceeding to the next stage.
The National Institute of Allergies and Infectious Diseases (NIAID) is co-funding the DELIVER trial with the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, both part of NIH. The study, known as MTN-042, is being conducted by the NIH-funded Microbicide Trials Network (MTN) at four sites in Malawi, South Africa, Uganda and Zimbabwe.
More information about the DELIVER trial is available at www.ClinicalTrials.gov under study identifier NCT03965923.
—Reporting by Hank Trout
Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-year resident of San Francisco, where he lives with his husband Rick. Follow him on Twitter @HankTroutWriter.