Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

• Status: Withdrawn
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Partnership for Microbicides, Inc.
• Collaborator: Gilead Sciences
• Treatments: Dapivirine; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Exclusion Criteria:

1. Become Pregnant and/or use oral PrEP outside the context of study.

2. At Screening or Enrollment, has a positive HIV test.

Inclusion Criteria:

1. Age 16 through 21 years at Enrollment, verified per site standard operation procedures.

2. Able and willing to provide adequate locator information and comply with all study procedural requirements.