The FACTS 001 study is a phase III, multi-centre, double-blind, randomised, placebo controlled trial that will test if tenofovir gel, when used before and after sex, is safe and effective at preventing sexually transmitted HIV and human simplex virus (HSV-2), the virus that causes genital herpes. The FACTS 001 was launched in October 2011, and will enrol 2,900 HIV-uninfected women aged 18-40 at nine clinical trial sites across South Africa.
The goals of the FACTS 001 study are to:
- Confirm whether using tenofovir gel dosing before and after sex is effective in preventing HIV and HSV-2 infection
- Generate evidence to better understand what level of effectiveness the gel can provide against HIV
- Establish whether use of tenofovir gel before and after sex can prevent HIV in women in a variety of settings across South Africa
- Provide the additional safety and efficacy data needed for product registration, with an indication for coitally-dependent dosing
In July 2010, the CAPRISA 004 study found that tenofovir gel reduces women’s risk of HIV infection by 39% when women inserted the gel into the vagina before and after sex. Amongst women who reported using the gel at least 80% of the time, the study showed a 54% reduction in HIV infection. In the same study, tenofovir gel also lowered women’s risk of getting genital herpes by 51%.
There is an urgent need to repeat the CAPRISA 004 study to confirm whether the gel really protects women against HIV infection and herpes infection.