At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 247 enrolled
Drug / intervention
FTC/TDF +1 moredrug
Likely dose
FTC/TDF 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 20, 2018·Updated Jun 22, 2023
In Brief
A Phase 2 clinical trial evaluating Dapivirine vaginal ring and FTC/TDF for HIV Infections. Completed, enrolled 247 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa, Uganda, Zimbabwe
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJan 2019
Primary CompletionSep 2021
TodayJul 2026
First PostedJul 20, 2018
Enrollment StartJan 14, 2019
Primary CompletionSep 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.0 years ago
Interventions
Dapivirine vaginal ringdevice
Vaginal ring containing 25 mg of dapivirine
FTC/TDFdrug
Tablet containing 200 mg FTC/300 mg TDF