At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 128 enrolled
Drug / intervention
dapivirine 4789 +2 moredrug
Likely dose
dapivirine 4789 2.5gfrom 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 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
International Partnership for Microbicides, Inc.·interventional·Posted Nov 27, 2008·Updated Oct 25, 2022
In Brief
A Phase 2 clinical trial evaluating dapivirine 4789, dapivirine gel 4759, and 1 other intervention for HIV-1 Infections. Completed, enrolled 128 participants across 5 sites.
Detailed Summary
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJul 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedNov 27, 2008
Enrollment StartJul 6, 2009
Primary CompletionJan 8, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.6 years ago
Interventions
dapivirine 4789drug
dapivirine gel 4789, 0.05%, 2.5g applied once daily
dapivirine gel 4759drug
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Drug placebodrug
HEC-based universal placebo gel, 2.5g applied once daily