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FACTS 001

Status
Completed
Phase
III
Principal Investigator(s)
Cynthia N Gama, MBCHB; Linda-Gail Bekker, MBChB, DCH, DTMH; Glenda Gray, MBBCH, FCPaeds; Thesla Palanee, PhD; Sydney L Sibiya, MBChB; atsontso Paul Mathebula, MBChB; Salome Charalambous, MBBCh, MSc; Khatija Ahmed, MBChB, FCPath, MMed; W.L. Brumskine, Ph.D
Objective

To assess the safety and effectiveness of intravaginal 1% tenofovir gel in prevention HIV-1 injection and HSV-2 infection in sexually active young women.

Prevention Option(s)
Microbicides
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
First dose: intravaginally up to 12 hours before each act of vaginal intercourse Second dose: within 12 hours after coitus No more than 2 applications within a 24 hour period.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
FIrst dose: intravaginally up to 12 hours before each act of vaginal intercourse Second dose: within 12 hours after coitus No more than 2 applications within a 24 hour period.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Placebo Comparator
Product Developers
CONRAD, FACTS, USAID
October 2011
December 2014
Enrollment
1 700
18
Years
40
Years
Sites

Desmond Tutu HIV Centre / University of Cape Town

Cape Town
South Africa

HIV Prevention Research Unit/MRC

Durban
South Africa

MatCH Edendale Research Center

Pietermaritzburg, Kwa-Zulu Natal
South Africa

Medunsa Clinical Research Unit / Ga-Ra

Pretoria
South Africa

Perinatal HIV Research Unit

Diepkloof, Johannesburg
South Africa

Qhakaza Mbokodo Research Clinic

Ladysmith
South Africa

Setshaba Research Centre

Shoshanguve
South Africa

The Aurum Institute

Rustenburg
South Africa

Wits Reproductive Health and HIV Institute / University of the Witwatersrand

Hillbrow
South Africa