NCT00469768

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	dapivirine reservoir intravaginal ring	a silicone elastomer reservoir ring containing 25mg of dapivirine
DRUG	dapivirine matrix intravaginal ring	a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
OTHER	placebo intravaginal ring	a silicone elastomer intravaginal ring containing no dapivirine

Timeline

• Start date: 2007-05-01
• Completion: 2007-08-01
• First posted: 2007-05-04
• Last updated: 2009-09-01

Locations

1 site across 1 country: Belgium