Data and Safety Monitoring Board Recommends FACTS 001 Study Continue to its Scheduled Conclusion

November 4, 2013

Cape Town, South Africa -- On October 26th, an independent Data and Safety Monitoring Board (DSMB) met with the FACTS 001 trial team and study sponsor, CONRAD, to determine progress by reviewing study conduct, safety and seroconversions in the active and placebo arms.  In their second and final interim review, the DSMB recommended the FACTS 001 trial continue to its scheduled conclusion.  Trial results will be available in late 2014.

FACTS 001 is a large-scale placebo-controlled study designed to provide clinical evidence for the regulatory approval of tenofovir gel.  In 2010, the CAPRISA 004 study showed that when inserted into the vagina before and after sex, a gel containing the antiretroviral tenofovir could reduce women’s risk of infection with HIV and HSV-2, a virus that causes genital herpes. The FACTS 001 study was designed as the confirmatory study to establish whether use of tenofovir gel before and after sex can prevent HIV in women in a variety of settings across South Africa, and to provide additional safety and efficacy data needed for product registration, with an indication for coitally-dependent dosing.

The Follow-on African Consortium for Tenofovir Studies (FACTS) is a South African-led clinical research collaboration jointly funded by South Africa’s Department of Science and Technology, the United States Agency for International Development (USAID), the Bill & Melinda Gates Foundation and the South African Department of Health.  The study is sponsored by CONRAD, a leading reproductive health research organization based in the USA, who also provided the study product. 

FACTS 001 is led by Protocol Chair Prof Helen Rees and Protocol Co-chair Prof Glenda Gray, two South African investigators based at Wits University in Johannesburg, South Africa. The consortium is coordinated at the Wits Reproductive Health and HIV Institute (Wits RHI) in Johannesburg with data management coordinated by the Perinatal HIV Research Unit (PHRU) in Soweto, South Africa. Other South African research institutes participating in the consortium include the Aurum Institute, the Desmond Tutu HIV Foundation, Maternal, Adolescent and Child Health MatCH, the South African Medical Research Council, the Medunsa Clinical Research Unit (MeCRU), the Qhakaza Mbokodo Research Clinic, the Setshaba Research Centre and the University of Cape Town.

If the FACTS study shows effectiveness, tenofovir gel used before and after sex could be an important HIV prevention option for women, because the gel can provide protection when they need it, where they need it. 

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