Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01337570

A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Safety and Efficacy Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in Women

Status
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (actual)
Sponsor
International Partnership for Microbicides, Inc. · Industry
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.

Conditions

Interventions

TypeNameDescription
OTHERDapivirineVaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
OTHERPlaceboVaginal Ring containing no drug substance
DRUGDapivirine

Timeline

Start date
2011-07-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2011-04-19
Last updated
2012-06-11

Locations

5 sites across 4 countries: Malawi, Rwanda, South Africa, Zimbabwe

Source: ClinicalTrials.gov record NCT01337570. Inclusion in this directory is not an endorsement.