NCT02028338

Study of Dapivirine Vaginal Ring (VR) in Adolescents

Phase 2a Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 15 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	placebo ring	intravaginal ring silicone elastomer intravaginal ring containing no drug product
COMBINATION_PRODUCT	dapivirine ring	intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine

Timeline

• Start date: 2014-06-27
• Primary completion: 2016-07-05
• Completion: 2018-06-08
• First posted: 2014-01-07
• Last updated: 2022-10-24
• Results posted: 2022-10-24

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study