At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Dapivirine gel +1 moredrug
Likely dose
Not stated in 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 Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 4, 2017·Updated Oct 19, 2021
In Brief
A Phase 1 clinical trial evaluating Dapivirine gel and Placebo gel for HIV Infections. Completed, enrolled 28 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesThailand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartOct 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 4, 2017
Enrollment StartOct 26, 2017
Primary CompletionSep 20, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.9 years ago
Interventions
Dapivirine geldrug
Dapivirine gel (0.05%); administered rectally
Placebo geldrug
Universal HEC placebo gel; administered rectally