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MTN-025 (HOPE)

Status
Ongoing
Phase
Open Label
III
Principal Investigator(s)
Dr. Derek Arbuckle
Objective
MTN-025 or the HIV Open-label Prevention Extension (HOPE) study is a follow-on trial to assess the continued safety of and adherence to a vaginal ring containing dapivirine in women.
Prevention Option(s)
Microbicides
Study Design
Open label
Arms and Assigned Interventions
Description
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Trial Sponsors
DAIDS, NICHD, NIMH, NIH
August 2016
December 2018
Enrollment
1 400
18
Years
40
Years
Population
Women
Sites

College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi

University of North Carolina - Lilongwe

Lilongwe
Malawi

Botha's Hill CRS

Westville, KwaZulu-Natal
South Africa

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal
South Africa

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town
South Africa

Isipingo CRS

Westville, KwaZulu-Natal
South Africa

Tongaat CRS

Tongaat, KwaZulu-Natal
South Africa

Verulam CRS

Verulam, KwaZulu-Natal
South Africa

Wits Reproductive Health and HIV Institute / University of the Witwatersrand

Hillbrow
South Africa

Makerere University - Johns Hopkins University Research Collaboration

Kampala
Uganda

UZ-UCSF HIV Prevention Trials Unit - Seke South

Chitungwiza
Zimbabwe

UZ-UCSF HIV Prevention Trials Unit - Spilhaus

Harare
Zimbabwe

Zengeza 3 Clinic

Harare
Zimbabwe