NCT02920827

Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring

A Double-Blind, Randomised, Placebo-Controlled Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Vaginal Ring Containing 25 MG of Dapivirine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.

Detailed description

The objective of this trial was to evaluate the feasibility of using a platinum-catalyzed matrix vaginal ring, containing 25 mg of dapivirine, to deliver investigational product for 28 continuous days. The specific objectives were to: 1. Assess the safety and tolerability of the vaginal ring containing dapivirine, when used continuously for 28 days, compared to a placebo ring 2. Assess dapivirine concentrations in plasma before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine 3. Assess dapivirine concentrations in vaginal fluids before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine. Safety was evaluated from clinical evaluations, clinical laboratory test results and adverse events (AEs). The pharmacokinetic (PK) evaluation was made based on systemic absorption from plasma concentrations and local disposition from vaginal fluid concentrations.

Conditions

• HIV Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dapivirine Vaginal Ring	A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days
COMBINATION_PRODUCT	Placebo vaginal ring	Placebo vaginal ring containing no dapivirine

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2016-09-30
• Last updated: 2017-09-08

Locations

1 site across 1 country: Belgium