NCT03593655

Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 16 Years – 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.

Detailed description

This study will evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females. The study will enroll healthy, HIV-uninfected adolescent and young adult females between 16 and 21 years of age. Participants will be randomized to one of two sequences of one VR containing 25 mg of dapivirine to be inserted monthly for 24 weeks and one 200 mg FTC/300 mg TDF oral tablet 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 during the third product use period. The study includes approximately 76 weeks of follow-up per participant. Participants will attend monthly study visits, which may include behavioral assessments/counseling; physical and pelvic examinations; and blood, urine, and pelvic sample collection.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DEVICE	Dapivirine vaginal ring	Vaginal ring containing 25 mg of dapivirine
DRUG	FTC/TDF	Tablet containing 200 mg FTC/300 mg TDF

Timeline

• Start date: 2019-01-14
• Primary completion: 2021-09-09
• Completion: 2021-09-09
• First posted: 2018-07-20
• Last updated: 2023-06-22
• Results posted: 2023-02-03

Locations

4 sites across 3 countries: South Africa, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study