NCT01539226

Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,959 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Detailed description

A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.

Conditions

• HIV Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Placebo Vaginal Ring	Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
COMBINATION_PRODUCT	Dapivirine Vaginal Ring, 25 mg	Dapivirine Vaginal Ring containing 25 mg of dapivirine

Timeline

• Start date: 2012-03-27
• Primary completion: 2016-12-13
• Completion: 2016-12-13
• First posted: 2012-02-27
• Last updated: 2022-10-19
• Results posted: 2022-10-19

Locations

7 sites across 2 countries: South Africa, Uganda