The Follow-on African Consortium for Tenofovir Studies (FACTS) was established in 2010 to provide clinical evidence for the safety and effectiveness required for licensure of 1% tenofovir gel, after the CAPRISA 004 study showed, for the first time, that a product inserted into the vagina (called a vaginal microbicide) may help reduce women’s risk of infection with HIV and HSV-2, a virus that causes genital herpes. The FACTS Consortium looks specifically at topical gel products containing tenofovir, an antiretroviral (ARV) drug used as a tablet to treat HIV.
The FACTS Consortium is currently conducting FACTS 001, 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 and HSV-2. The study is a phase III licensure study that is aimed at confirming and expanding the ground breaking findings of the CAPRISA 004 tenofovir gel trial. The consortium is also in the planning phase for FACTS 002, an adolescent safety study designed to test the safety and acceptability of tenofovir gel in 16 and 17-year-old South African young women.
“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, FACTS Protocol Chair and Director of the Wits Reproductive Health and HIV Institute