At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 394 enrolled
Drug / intervention
Dapivirine (DPV) Vaginal Ring (VR)-004 +1 moredrug
Likely dose
Dapivirine (DPV) Vaginal Ring (VR)-004 25 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.
Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 25, 2019·Updated Aug 4, 2023
In Brief
A Phase 3 clinical trial evaluating Dapivirine (DPV) Vaginal Ring (VR)-004 and Truvada Tablet for HIV Infections. Completed, enrolled 394 participants across 4 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesMalawi, South Africa, Uganda, Zimbabwe
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartSep 2020
Primary CompletionNov 2021
TodayJul 2026
First PostedOct 25, 2019
Enrollment StartSep 24, 2020
Primary CompletionNov 4, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.7 years ago
Interventions
Dapivirine (DPV) Vaginal Ring (VR)-004drug
Vaginal ring containing 25 mg of DPV
Truvada Tabletdrug
Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)