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IPM 027 (The Ring Study)

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
Results
Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women
Official Code
NCT01539226
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