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Status
Completed
Phase
III
Principal Investigator(s)
Jared Baeten
Objective
To assess the safety and effectiveness of a silicone elastomer vaginal matrix ring containing dapivirine worn for a month at a time.
*Results released in February, 2016 found the dapivirine ring reduced the risk of HIV infection by 27 percent overall. Additional analysis released in July, 2016 found that among women who appeared to use the ring most regularly, HIV risk was cut by more than half across all analyses, and in some, by 75 percent or more.
*Results released in February, 2016 found the dapivirine ring reduced the risk of HIV infection by 27 percent overall. Additional analysis released in July, 2016 found that among women who appeared to use the ring most regularly, HIV risk was cut by more than half across all analyses, and in some, by 75 percent or more.
Prevention Option(s)
Microbicides
Study Design
Controlled
Placebo
Randomized
Arms and Assigned Interventions
Description
4-week vaginal dapivirine (25 mg) ring
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
MTN, NIAID, NIMH, NICHD
Product Developers
IPM
July 2012
August 2015
18
Years
45
Years
Population
Women
Sites
Botha's Hill CRS
Westville, KwaZulu-Natal
South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal
South Africa
Emavundleni (EMA) CRS
Cape Town
South Africa
eThekwini CRS
Durban, KwaZulu-Natal
South Africa
Isipingo CRS
Westville, KwaZulu-Natal
South Africa
Makerere University - Johns Hopkins University Research Collaboration
Kampala
Uganda
Seke South Clinical Research Site
Harare
Zimbabwe
Spilhaus Clinical Research Site
Harare
Zimbabwe
Tongaat CRS
Tongaat, KwaZulu-Natal
South Africa
Umkomaas CRS
Umkomaas, KwaZulu-Natal
South Africa
UNC Lilongwe CRS
Lilongwe
Malawi
Verulam CRS
Verulam, KwaZulu-Natal
South Africa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg
South Africa
Zengeza 3 Clinic
Harare
Zimbabwe
Malawi College of Medicine John Hopkins University Clinical Research Site
Blantyre
Malawi