Study of Dapivirine Vaginal Ring (VR) in Adolescents

Status Completed

Clinical Trial 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.

Clinical Trial Description

MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-weeks of study product use. Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 24 week study product use period. Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02028338
Study type	Interventional
Source	International Partnership for Microbicides, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	June 27, 2014
Completion date	June 8, 2018

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