The first clinical trial specifically designed to test the safety of the monthly dapivirine vaginal ring in pregnant women has begun in southern and eastern Africa. The National Institutes of Health-funded study also will test the safety of a daily oral antiviral tablet for HIV pre-exposure prophylaxis (PrEP) in pregnant women and will assess how much they accept and use these two HIV prevention tools. The study will complement an ongoing NIH-funded trial of PrEP in adolescents and young women during pregnancy and the first six months after birth. PrEP is available in some countries and is being rolled out in others, while the dapivirine ring is under regulatory review by the European Medicines Agency for potential use in sub-Saharan Africa.
Women need reliable HIV prevention methods that they know are safe during pregnancy for themselves and their babies. 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." Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH
Studies have found that for women of reproductive age, the risk of acquiring HIV is two to four times greater during pregnancy and the first six months after childbirth than at other times. In sub-Saharan Africa, women tend to be pregnant for a substantial portion of their reproductive years, with an estimated 5.1 births per woman.
Limited evidence from earlier clinical trials and reports suggests that PrEP and the dapivirine ring are safe for pregnant women and their fetuses, but the safety of these tools during pregnancy has not yet been proven in a clinical trial designed specifically to address this question.
The new trial is called DELIVER: A Phase 3b Safety Study of the Dapivirine Ring and PrEP in Pregnant Women.
Using PrEP to prevent HIV involves taking an oral tablet containing two anti-HIV drugs, emtricitabine and usually tenofovir, once a day. Numerous studies have shown that PrEP is about 99% effective at protecting people from sexually acquiring HIV when taken daily.
The dapivirine vaginal ring slowly releases the anti-HIV drug dapivirine in the vagina and is replaced once a month. Two large, Phase 3 clinical trials demonstrated that the dapivirine ring is well-tolerated and roughly 30% effective overall at protecting women from acquiring HIV through vaginal sex.
Another NIH-funded trial that began in early 2019 has been studying whether PrEP drug concentrations in adolescents and young women aged 16-24 years are different during pregnancy than at other times. The trial, called IMPAACT 2009, soon will begin testing the safety, acceptability and efficacy of PrEP drugs during pregnancy and the first six months after birth in this population and their infants in southern and eastern Africa. Results are expected in 2022.
NIAID is sponsoring the DELIVER trial and co-funding it 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, also 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. Gilead Sciences, Inc., and the International Partnership for Microbicides, which developed the dapivirine ring, are donating PrEP medication and rings for the study, respectively.
The design of the DELIVER trial has been carefully reviewed and approved by the communities, national health authorities, ethicists and other key stakeholders where the study will take place. Data from DELIVER may help some countries decide whether and how to roll out PrEP among pregnant women. If the ring receives regulatory approval, the study may inform its rollout in that population as well. Related Stories
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