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MTN 020 (ASPIRE)

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.

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
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