CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,104 enrolled
Drug / intervention
Dapivirine (DPV) Vaginal Ring (VR) +1 moredrug
Likely dose
Dapivirine (DPV) Vaginal Ring (VR) 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.

Search/NCT03965923
NCT03965923Phase 3Completed

Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 29, 2019·Updated Aug 12, 2025

In Brief

A Phase 3 clinical trial evaluating Dapivirine (DPV) Vaginal Ring (VR) and Truvada Tablet for HIV Infections. Completed, enrolled 1,104 participants across 4 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesMalawi, South Africa, Uganda, Zimbabwe
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 29, 2019
Enrollment StartJan 9, 2020
Primary CompletionMay 13, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.1 years ago

Interventions

Dapivirine (DPV) Vaginal Ring (VR)drug

Vaginal ring containing 25 mg of DPV

Truvada Tabletdrug

Tablet taken orally