The Follow-on African Consortium for Tenofovir Studies (FACTS) is a newly-created South African research consortium established to conduct clinical studies to determine whether tenofovir gel is safe and effective at protecting women from HIV and herpes simplex virus (HSV-2). 2013
The FACTS Consortium will be conducting two HIV prevention studies. FACTS 001, which is underway, is a large-scale placebo-controlled 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 enrol a minimum of 2,200 HIV-negative women and is aimed at confirming and expanding the groundbreaking findings of the CAPRISA 004 tenofovir gel trial. FACTS 002 is an adolescent safety study designed to test the safety and acceptability of tenofovir gel in 16 and 17-year-old South African young women.
If the FACTS studies confirm that tenofovir gel is effective, these combined data could contribute to the licensure of the first vaginal microbicide product and subsequently provide women with a powerful new women-controlled HIV prevention method.
“The South African government’s support for FACTS demonstrates a new era of collaboration between researchers and government with the common vision of preventing HIV infections in women.”
– Professor Helen Rees, Director of the Wits Reproductive Health and HIV Institute