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Status
Completed
Phase
IIb
Principal Investigator(s)
Zvavahera M. Chirenje, MD, FRCOG; Jeanne Marrazzo, MD, MPH
Objective
To determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF or oral TDF/FTC compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.
Results: None of the drug regimens evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low.
Prevention Option(s)
Microbicides
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Daily dosing
Mode of Delivery
Tablet
Products
TDF
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Description
Daily dosing
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Gel
ARMs
Placebo Comparator
Official Code
Trial Sponsors
MTN, NIAID, CONRAD, Gilead, MMH, NICHD
Product Developers
CONRAD, Gilead Sciences, Inc.
August 2009
August 2012
Enrollment
5 029
18
Years
45
Years
Population
Women
Sites
Wits Reproductive Health and HIV Institute / University of the Witwatersrand
Hillbrow
South Africa
Zengeza 3 Clinic
Harare
Zimbabwe
Soweto MTN CRS
Johannesburg, Gauteng
South Africa
Overport CRS
Asherville, KwaZulu-Natal
South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal
South Africa
Aurum Institute
Klerksdorp
South Africa
Tongaat CRS
Tongaat, KwaZulu-Natal
South Africa
Umkomaas CRS
Umkomaas, KwaZulu-Natal
South Africa
Verulam CRS
Verulam, KwaZulu-Natal
South Africa
Isipingo CRS
Westville, KwaZulu-Natal
South Africa
Botha's Hill CRS
Westville, KwaZulu-Natal
South Africa
Makerere University - Johns Hopkins University Research Collaboration
Kampala
Uganda
UZ-UCSF HIV Prevention Trials Unit - Spilhaus
Harare
Zimbabwe
UZ-UCSF HIV Prevention Trials Unit - Seke South
Chitungwiza
Zimbabwe
Kampala
Uganda