FACTS 001 trial announced in South Africa

Yesterday was a big day in the world of HIV prevention and treatment. The FACTS 001 study was announced - a follow-up study to confirm the effectiveness of tenofovir and to verify the CAPRISA 004 results in "larger, more diverse populations". The Phase III trial will be 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). Read on for excerpts from two articles on the study.

Times LIVE

The Big Read: South African scientists are launching an important HIV clinical trial to confirm the efficacy of a gel that reduces the risk of women getting HIV.

This is the first South African-led consortium to conduct HIV research at seven centres, said the executive director of the Wits Reproductive Health and HIV Institute, Professor Helen Rees.

Until now, multi-site trials were led by international scientists collaborating with local peers.

"The planning for the Facts study is well under way and we hope to be in the field by August," said Rees.

The past year has seen a revolution in HIV-prevention research sparked by three exciting results - one being the gel.

A Tenofovir vaginal gel proved 39% effective at protecting young women from HIV and halved the risk of Herpes HSV-2, according to the Caprisa 004 study in KwaZulu-Natal.

Facts aims to confirm these results.

To read on, click here.

allAfrica.com

Pretoria — After encouraging results on a vaginal gel containing the antiretroviral drug tenofovir, which reduces HIV infection and risk of contracting genital herpes, a follow-up study to test the safety of the gel has been launched.

The Phase III trial, to be known as FACTS 001, will be conducted by the Follow-on African Consortium for Tenofovir Studies (FACTS) led by Professor Helen Rees, who is the Director of the Wits Reproductive Health and HIV Institute (WRHI). It is expected to start by the end of July and run for 24 months.

The study prior to this, known as CAPRISA 004, was conducted last year by the Centre for the Aids Programme of Research in South Africa (CAPRISA) on nearly 900 women in KwaZulu-Natal.

It showed that the use of the gel reduced HIV infection by 39 percent and also reduces the risk of contracting genital herpes by 51 percent.

However, CAPRISA 004 was a relatively small trial (Phase IIb trial) and was not designed for licensure purposes.

On Tuesday, the Department of Science and Technology, in partnership with the United States, launched FACTS 001, which will test the safety and effectiveness of 1 percent tenofovir gel.

FACTS 001 will be a bigger study than CAPRISA 004, involving 2200 women aged 18 to 30 years at seven trial sites across South Africa.

Read the rest of the article here.

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