At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 96 enrolled
Drug / intervention
placebo ring +1 morecombination
Likely dose
dapivirine ring 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 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females
International Partnership for Microbicides, Inc.·interventional·Posted Jan 7, 2014·Updated Oct 24, 2022
In Brief
A Phase 2 clinical trial evaluating placebo ring and dapivirine ring for Human Immunodeficiency Virus. Completed, enrolled 96 participants across 11 sites.
Detailed Summary
To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesUnited States
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartJun 2014
Primary CompletionJul 2016
Study CompletionJun 2018
TodayJul 2026
First PostedJan 7, 2014
Enrollment StartJun 27, 2014
Primary CompletionJul 5, 2016
Study CompletionJun 8, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.5 years ago
Interventions
placebo ringcombination
intravaginal ring silicone elastomer intravaginal ring containing no drug product
dapivirine ringcombination
intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine