At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,629 enrolled
Drug / intervention
Dapivirine Vaginal Ring +1 morecombination
Likely dose
Dapivirine Vaginal Ring 25mgfrom 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 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
International Partnership for Microbicides, Inc.·interventional·Posted Jun 12, 2012·Updated Dec 21, 2022
In Brief
A Phase 3 clinical trial evaluating Dapivirine Vaginal Ring and Placebo Ring for HIV Infections. Completed, enrolled 2,629 participants across 7 sites in 4 countries.
Detailed Summary
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesMalawi, South Africa, Uganda, Zimbabwe
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionJul 2015
Study CompletionDec 2015
TodayJul 2026
First PostedJun 12, 2012
Enrollment StartJul 24, 2012
Primary CompletionJul 3, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.1 years ago
Interventions
Dapivirine Vaginal Ringcombination
Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months
Placebo Ringcombination
Vaginal ring containing no drug substance