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HPTN 035

Status
Completed
Phase
IIb
Objective

To test the safety and efficacy of BufferGel and PRO 2000. 

Prevention Option(s)
Microbicides
Study Design
Controlled
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
Mode of Delivery
Gel
Products
BufferGel
ARMs
Experimental
Description
Apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
Mode of Delivery
Gel
Products
Pro 2000/5 gel
ARMs
Experimental
Description
Placebo gel
Mode of Delivery
Gel
ARMs
Placebo Comparator
Description
No intervention
ARMs
Placebo Comparator
Trial Sponsors
NIAID, NICHD, NIMH, MTN
January 2005
September 2008
Enrollment
3 101
18
Years
Population
Women
Sites

Hospital of the University of Pennsylvania CRS

Philadelphia, Pennsylvania
United States of America

University of North Carolina - Lilongwe

Lilongwe
Malawi

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

Kamwala Clinical Research Site

Lusaka
Zambia

UZ-UCSF HIV Prevention Trials Unit - Seke South

Chitungwiza
Zimbabwe

UZ-UCSF HIV Prevention Trials Unit - Spilhaus

Harare
Zimbabwe

Hlabisa CRS

KwaZulu-Natal
South Africa