NCT04140266

Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.

Detailed description

This study will evaluate the safety and drug detection of the dapivirine (DPV) vaginal ring (VR) and oral Truvada in breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned to receive either the DPV VR or oral Truvada. Mothers randomized to the DPV VR will use the VR continuously for approximately one month (4 weeks), replacing the VR each month for approximately three months (12 weeks). Mothers using the Truvada tablet will take one tablet by mouth daily for approximately three months (12 weeks). Study visits will occur at Day 0, Weeks 1 and 2, and Months 1, 2, 3, and 3.5. Study visits may include behavioral assessments; product acceptability assessments; infant feeding assessments; physical examinations; blood, urine, and breast milk collection; and pelvic examination and specimen collection.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dapivirine (DPV) Vaginal Ring (VR)-004	Vaginal ring containing 25 mg of DPV
DRUG	Truvada Tablet	Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)

Timeline

• Start date: 2020-09-24
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2019-10-25
• Last updated: 2023-08-04
• Results posted: 2023-08-04

Locations

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

Regulatory

• FDA-regulated drug study