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MTN 020 (ASPIRE)

Status
Completed
Phase
III
Principal Investigator(s)
Jared Baeten, Thesla Palanee
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% 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 50% across all analyses, and for those who benefitted the most, by 75% or more.

Last updated October 20, 2022

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
Results
Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women
Official Code
NCT01617096
Related Publications
Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial
Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa
Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial
Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study
Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women
Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring
Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE
Similar Trials
MTN 025 (HOPE)
Trial Sponsors
MTN, NIAID, NIMH, NICHD
Product Developers
IPM
July 2012
December 2015
Date of Enrollment Completion
July 3, 2015
Enrollment
3 540
18
Years
45
Years
Population
Women
Sites

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Seke South Clinical Research Site

Harare
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Verulam CRS

Verulam, KwaZulu-Natal
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Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg
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Zengeza 3 Clinic

Harare
Zimbabwe

Malawi College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi