CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 941 enrolled
Drug / intervention
Dapivirine Vaginal Ring-004drug
Likely dose
Dapivirine 25 mg vaginal ring inserted monthlyAI-extracted
Key inclusion· 5
  • ✓Previously enrolled in the IPM 027 trial
  • ✓HIV-negative at screening using HIV algorithm
  • ✓Using effective contraception or post-menopausal
  • ✓Willing to refrain from other research trials involving drugs, vaccines, medical devices, or microbicides
Key exclusion· 6
  • ✕Investigational product permanently discontinued due to adverse event or safety concern in IPM 027
  • ✕Post-exposure prophylaxis (PEP) use within 2 months of screening (may enroll after 2 months post-PEP with negative HIV test)
  • ✕Currently pregnant, intends to become pregnant, or currently breast-feeding
  • ✕Drug abuse or alcohol dependence in the 12 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02862171
NCT02862171Phase 3Completed
CompareCT.gov

A Follow-On, Open-Label Trial To Assess Continued Safety Of And Adherence To The Dapivirine (25 Mg) Vaginal Ring-004 In Healthy, HIV-Negative Women

International Partnership for Microbicides, Inc.·interventional·Posted Aug 10, 2016·Updated Oct 25, 2022

In Brief

A Phase 3 clinical trial evaluating Dapivirine Vaginal Ring-004 for HIV Prevention. Completed, enrolled 941 participants across 6 sites in 2 countries.

Detailed Summary

A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesSouth Africa, Uganda
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartJul 12, 2016
Primary CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.9 years ago

Interventions

Dapivirine Vaginal Ring-004drug

To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial