The Deputy Minister of Science and Technology, Derek Hanekom, and United States (US) Ambassador Donald Gips today announced a follow-on trial to test the safety and effectiveness of 1% tenofovir gel.
South Africa is leading the charge to provide the world with the first safe and effective microbicide to protect women against HIV.
Led by Professor Helen Rees, the Director of the Wits Reproductive Health and HIV Institute (WRHI), the Follow-on African Consortium for Tenofovir Studies (FACTS) will conduct the Phase III trial to be known as FACTS 001.
FACTS 001 follows the positive results of the Centre for AIDS Programme of Research (CAPRISA) 004 trial last year, which tested the safety and effectiveness of 1% tenofovir gel among nearly 900 women at two sites in South Africa. The research found that using the gel before and after sex provided moderate protection against sexually transmitted HIV and Herpes Simplex Virus 2 (HSV-2). However, CAPRISA 004 was a relatively small trial (Phase IIb trial) and was not designed for licensure purposes.
FACTS 001 is a critical study being funded by the Department of Science and Technology, the Department of Health and the United States government through the US Agency for International Development (USAID). CONRAD, a leading reproductive health research organisation based in the US, is providing the gel for the study andthe Technology Innovation Agency (TIA), a South African government agency focusing on supporting technological innovation, funds the technical support and monitoring carried out by the African Clinical Research Organisation (ACRO).
In a media briefing, Deputy Minister Hanekom said the South African government was very proud of the collaboration between the governments of South Africa and the United States of America.
"We are very pleased to be associated with the FACTS 001 study and hope that the results of this study will confirm the positive CAPRISA 004 results, making it possible to provide a technology that can help protect women against HIV and AIDS. We are very proud of the South African researchers that constantly prove that they are world-class and we would also like to honour the women that are an integral part of these studies – they are the unsung heroes."
Ambassador Gips said the United States, through the President's Emergency Plan for AIDS Relief and President Obama's Global Health Initiative, was working hand-in-hand with the South African government to turn the tide of this disease.
"We are committed to empowering women and girls to protect themselves by finding new HIV prevention options. Confirming tenofovir gel's effectiveness is a fundamental and essential step in that direction," said Ambassador Gips.
Professor Rees agreed that the establishment of the FACTS consortium to confirm the effectiveness of the first potential vaginal microbicide gel for women and enable licensure was extremely exciting for South African researchers.
"The South African government's support for FACTS demonstrates a new era of collaboration between researchers and government with the common vision of preventing HIV infections in women," said Prof. Reese.
FACTS 001 is urgently needed to provide sufficient evidence to license a new drug. The phase III study is a multi-centre, placebo-controlled, randomised trial designed to assess the safety and effectiveness of tenofovir gel used before and after sex to provide protection from sexually transmitted HIV and HSV-2 infection.
FACTS 001 plans to enroll 2 200 women aged 18 to 30 years old at seven trial sites across South Africa. This confirmatory trial is an essential step on the path to the licensing of the first potential vaginal microbicide product that would help women protect themselves from HIV and HSV-2 infection.
About facts: The Follow-on African Consortium for Tenofovir Studies is led by Protocol Chair, Professor Helen Rees, and co-chaired by Professor Gita Ramjee and Prof. Glenda Gray. The consortium is coordinated by WRHI, with the HIV Prevention Research Unit at the Medical Research Council (MRC) coordinating the laboratory and pharmacy, and the Perinatal HIV Research Unit (PHRU) at Chris Hani Baragwanath coordinating the data management. FACTS 001 will include sites at the following seven research institutions: Aurum Institute, Desmond Tutu HIV Foundation, MRC, Medunsa Clinical Research Unit, the PHRU, Setshaba Research Centre and WRHI.
FACTS is funded by the Department of Science and Technology, the national Department of Health and United States Agency for International Development (USAID). FACTS studies are sponsored by CONRAD, a leading reproductive health research organisation, with products provided with support from the Bill and Melinda Gates Foundation and Gilead. Technical support and monitoring are provided by ACRO, with funds from TIA.
About USAID's response to HIV and AIDS: Since the inception of its HIV and AIDS programme in 1986, USAID has been on the forefront of the global Aids crisis. Today, with more than 33 million people living with or affected by HIV and AIDS, USAID is a key partner in the US President's Emergency Plan for AIDS Relief, the largest and most diverse HIV and AIDS prevention, care, and treatment initiative in the world.
About CONRAD: CONRAD (http://www.conrad.org) was established in 1986 and is a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School in Norfolk, Virginia, where it has laboratories and a clinical research centre.
CONRAD is committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV and Aids and other sexually transmitted diseases. CONRAD provided the gel formulation of tenofovir for the CAPRISA 004 trial.
Media contacts and queries:
Department of Science and Technology
Veronica Mohapeloa
Tel: 012 843 6788
Cell: 082 882 3818
United States Diplomatic Mission to South Africa
Elizabeth Kennedy Trudeau
Tel: 012 431 4000 (ext. 4217)
Cell: 079 111 8280
E-mail: trudeauek@state.gov
United States Diplomatic Mission to South Africa
Laura Santini
Tel: 012 431 4161
Cell: 079 111 6723
E-mail: santiniML@state.gov
Follow-on African Consortium for Tenofovir Studies (FACTS)
Deborah Baron
Tel: 078 396 6236
E-mail: dbaron@wrhi.ac.za
