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MTN 003 (VOICE)

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.

 

ResultsNone 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
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