NCT00613249

A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels

A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dapivirine Gel 4750, 0.05%, 2.5g	intravaginal gel, dosed daily
DRUG	Dapivirine Gel 4789, 0.05%, 2.5g	intravaginal gel, dosed daily
DRUG	HEC-based Placebo Gel	intravaginal gel, dosed daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-02-13
• Last updated: 2009-03-27

Locations

1 site across 1 country: Belgium