The National Institutes of Health (NIH) has launched the first clinical trial specifically designed to test the safety of the monthly dapivirine vaginal ring in pregnant women in southern and eastern Africa. The study will also 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 2 HIV prevention tools. 

The study, called DELIVER: A Phase 3b Safety Study of the Dapivirine Ring and PrEP in Pregnant Women, will complement an ongoing NIH-funded trial of PrEP in adolescents and young women during pregnancy and the first 6 months after birth.

“Women need reliable HIV prevention methods that they know are safe during pregnancy for themselves and their babies,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a prepared statement to the NIH. “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.”

Previous studies have found that for women of reproductive age, the risk of acquiring HIV is 2 to 4 times greater during pregnancy and the first 6 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, according to the study.

With these factors, there is limited evidence from earlier clinical trials and reports suggest that PrEP and the dapivirine ring are safe for pregnant women and their fetuses. However, the safety of these tools during pregnancy has not yet been proven in a clinical trial designed specifically to address this question.
 


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The DELIVER study team plans to enroll 750 healthy, HIV-negative women from 18-40 years of age who have an uncomplicated singleton pregnancy. Each woman will be randomized to receive either the dapivirine vaginal ring or PrEP in a 2-to-1 ratio. The women will then be asked to use their assigned product until the end of their pregnancy or 42 weeks gestation, whichever comes first. Subsequently, the study team will enroll the mothers’ newborn infants.

The study team will enroll participants in 4 stages, beginning with women latest in pregnancy and will pause to conduct a safety analysis before enrolling the next group.

The first enrollment group of 150 women will begin using their assigned product at 36 to 37 weeks gestation. The study team will follow these women through the end of their pregnancy and enroll their newborns for additional safety assessments, including an independent, interim safety analysis to determine whether the next group of women can be enrolled or the study needs to stop early.

If it is safe to proceed with the study, the process will be repeated with a group of 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. The women involved in these groups will be followed until approximately 6 weeks after their pregnancy ends, and the infants will be followed until they are approximately 1-year-old.

Any medical problems and deaths among the women and infants, including birth defects in the infants, will be recorded by the study team. In addition, the team will track the frequency of full-term births, premature live births, and pregnancy losses. The investigators will track pregnancy complications associated with exposure to PrEP or the dapivirine ring, measure levels of study drugs in the infants, and determine the extent to which women accept and use their assigned study product.

To assess the acceptability of the study products, questionnaires will be used and the team will continue to evaluate changes in women’s genital microenvironment associated with the use of PrEP or the dapivirine ring during pregnancy.

REFERENCE

NIH-funded clinical trial to test PrEP, dapivirine ring for safety in pregnany women. NIH. https://www.nih.gov/news-events/news-releases/nih-funded-clinical-trial-test-prep-dapivirine-ring-safety-pregnant-women. Published February 10, 2020. Accessed February 18, 2020.