FACTS 001 Study Announces Enrollment of First Study Participant

October 26, 2011

The Follow-on African Consortium for Tenofovir Studies (FACTS) has enrolled the first study participant in FACTS 001, a pivotal Phase III clinical trial of vaginal tenofovir gel, a microbicide for the prevention of HIV infection. Five sites in Cape Town, Johannesburg, Soweto, Rustenburg and Pretoria have begun to screen women, and the Desmond Tutu HIV Centre has enrolled the first study participant. FACTS 001, is a large-scale, randomised placebo-controlled clinical study designed to test the safety and effectiveness of vaginal tenofovir gel used before and after sex to protect women against HIV infection and also against HSV-2, a virus that causes genital herpes. The study will enroll a minimum of 2,200 HIV-negative women aged 18-30 years at nine sites in South Africa. 

FACTS 001 is sponsored by CONRAD and funded by the South African Department of Science and Technology, the U.S. Agency for International Development (USAID) and the South African Department of Health. CONRAD and Gilead Sciences, Inc. are providing the study products.

To learn more about the FACTS Consortium and the FACTS 001 Study, please go to: 

1911 North Fort Myer Drive, Suite 900, Arlington, Virginia 22209   T: (703) 524-4744 |