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Large Trial of Tenofovir Gel for Women Set to Begin in South Africa

June 15, 2011

A 24-month clinical trial looking at the effectiveness of tenofovir gel use among women to reduce the risk of HIV infection is set to begin in South Africa in late July or early August, the Mail & Guardian reports.

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The study, called Follow-on African Consortium for Tenofovir Studies (FACTS), aims to confirm the findings of the Caprisa 004 trial, which "found that a microbicide containing 1% tenofovir, if used before and after sex, reduced the chances of women contracting HIV by 39%" and halved the risk of contracting genital herpes, according to Business Day. But because Caprisa 004 involved a smaller number of women, "the findings had a wide margin of error, with the efficacy of HIV protection estimated to lie between 6% and 60%, said FACTS protocol chair Prof Helen Rees," the newspaper writes (Kahn, 6/15).

The FACTS trial, which will involve 2,200 sexually active women at seven sites in South Africa, will cost $300 million rand and be funded by the South African Departments of Science and Technology and Health and USAID, according to Times Live (Mclea, 6/14). In a USAID statement, Administrator Rajiv Shah said, "We believe confirming tenofovir gel's effectiveness and obtaining regulatory approval is a fundamental and essential step in that direction, and we look forward to supporting South Africa's leadership in this endeavor" (6/14).

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