CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Dapivirine Vaginal Ring +1 moredrug
Likely dose
Dapivirine Vaginal 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.

Search/NCT02010593
NCT02010593Phase 2Completed
CompareCT.gov

Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Postmenopausal Female Population

International Partnership for Microbicides, Inc.·interventional·Posted Dec 13, 2013·Updated Nov 3, 2022

In Brief

A Phase 2 clinical trial evaluating Dapivirine Vaginal Ring and Placebo Vaginal Ring for Human Immunodeficiency Virus. Completed, enrolled 96 participants across 3 sites.

Detailed Summary

This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 13, 2013
Enrollment StartDec 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.6 years ago

Interventions

Dapivirine Vaginal Ringdrug

Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-\[\[4-\[(2,4,6-trimethylphenyl)amino\]-2- pyrimidinyl\]amino\]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR

Placebo Vaginal Ringdrug

The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.