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Status
Ongoing
Phase
II
Principal Investigator(s)
Gonasagrie Nair, MBChB, MPH
Objective
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
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.
Last update September 23, 2022
Prevention Option(s)
Microbicides
PrEP
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Sequence A: Dapivirine vaginal ring + FTC/TDF
Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks.
Mode of Delivery
Ring
Tablet
Products
Dapivirine Ring
TDF/FTC (Truvada)
ARMs
Experimental
Description
Experimental: Sequence B: FTC/TDF + Dapivirine vaginal ring
Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks.
Mode of Delivery
Ring
Tablet
Products
Dapivirine Ring
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Related Publications
Trial Sponsors
NIAID (DAIDS-ES: 12066), NICHD, NIMH, NIH, IPM
January 2019
October 2021
Enrollment
247
16
Years
21
Years
Population
Women
Sites
Emavundleni Desmond Tutu HIV Centre CRS
Cape Town
South Africa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg
South Africa
Kisumu CRS
Kenya
UZ-UCSF HIV Prevention Trials Unit - Spilhaus
Harare
Zimbabwe
MU-JHU Research Collaboration CRS
Kampala
Uganda