Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

08 November 2011

FACTS 001: A Quick Update

 * Original content from our Mapping Pathways blog team

Remember the FACTS 001 trial that was announced in South Africa in June 2011? (Read our blog post on it if you don’t.) We are very happy to share an exciting update about it!

On October 21, 2011, the first study participant was enrolled in this Phase III clinical trial of vaginal tenofovir gel (a microbicide, meant to protect women against HIV infection). The Desmond Tutu HIV Foundation brought the first participant on board. Five sites have begun screening women, in Cape Town, Johannesburg, Soweto, Rustenburg, and Pretoria.

To give you a quick recap, this landmark trial is a large-scale, randomized, placebo-controlled clinical study that is meant to test the safety and confirm the effectiveness of tenofovir gel used before and after sex to protect women against HIV infection, as well as HSV-2 (a virus that causes genital herpes). A total of 2,200 HIV-negative women between 18-30 years of age are going to be enrolled across nine sites in South Africa.

Essentially, the aim is to verify the CAPRISA 004 results in "larger, more diverse populations". The trial is being conducted by FACTS (Follow-on African Consortium for Tenofovir Studies) and led by Professor Helen Rees, the Executive Director of WHRI (Wits Reproductive Health and HIV Institute). 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.

So, why is this trial such a milestone in the world of HIV prevention? If this study, along with VOICE which is testing the use of tenofovir gel and oral Truvada tablets, confirms that tenofovir gel is safe and effective, it could lead to the first licensed vaginal microbicide product. Women would then have access to and be able to control this brand-new HIV prevention method. Truly revolutionary developments!

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

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