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Status
Completed
Phase
III
Objective
To assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
*The Ring Study reported results early in February 2016 after an independent safety and monitoring board recommended the study proceed to final analysis. It has moved to open-label in South Africa and Uganda. In July, 2016 new analyses announced by MTN at AIDS 2016 found that, among women who appeared to use the monthly ring consistently, HIV risk was cut by at least 56 percent — a statistically significant finding.*
Prevention Option(s)
Microbicides
Study Design
Controlled
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Vaginal ring containing 25mg dapivirine; one ring inserted once every 4 weeks over 24 months.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Vaginal ring containing no drug substance
Mode of Delivery
Ring
ARMs
Placebo Comparator
Official Code
Trial Sponsors
International Partnership for Microbicides, Inc.
April 2012
December 2016
Enrollment
1 959
18
Years
45
Years
Population
Women
Sites
Madibeng Centre for Research
Brits
South Africa
Prevention of HIV/AIDS (PHIVA) - Pinetown
Pinetown
South Africa
Maternal, Adolescent and Child Health - Edendale
Edendale
South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith
South Africa
Desmond Tutu HIV Foundation - Masiphumelele
Masiphumelele
South Africa
Ndlovu Medical Centre
Limpopo
South Africa
MRC/UVRI Uganda Research Unit on AIDS
Masaka
Uganda