NCT03965923

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,104 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Detailed description

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants. Participants will be assigned to one of three cohorts based on gestational age: * Cohort 1: 36 0/7 weeks - 37 6/7 weeks * Cohort 2: 30 0/7 weeks - 35 6/7 weeks * Cohort 3: 12 0/7 weeks - 29 6/7 weeks Within each cohort, participants will be randomized to receive either DPV VR or oral Truvada. Participants randomized to the DPV VR will use the VR continuously for approximately one month, replacing the VR each month. Participants taking the Truvada tablet will take one tablet orally per day. Participants will use their assigned study product until their pregnancy outcome, but no later than 41 6/7 weeks of gestation. Participants will attend several study visits throughout the study and study staff will also contact participants by phone at different timepoints throughout the study. The total duration of study participation will vary depending on gestational age at time of enrollment and length of pregnancy prior to pregnancy outcome and will range from approximately 12 weeks or less for Cohort 1 to approximately 36 weeks or less for Cohort 3. Infants born to study participants will be followed for approximately 52 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dapivirine (DPV) Vaginal Ring (VR)	Vaginal ring containing 25 mg of DPV
DRUG	Truvada Tablet	Tablet taken orally

Timeline

• Start date: 2020-01-09
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2019-05-29
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

4 sites across 4 countries: Malawi, South Africa, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study