• Salim Abdool Karim
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A South African team of researchers will soon lead a major follow-up clinical trial to confirm the effectiveness and safety of tenofovir gel, an antiretroviral microbicide, which has been proven to reduce HIV infection in women.
The clinical trial, named the Facts 001 study, will expand on the findings of the initial phase IIb study, called Caprisa 004, which were presented last year. The Caprisa 004 study examined the concept of using a product for Aids treatment in HIV prevention.
The Durban-based Centre for the Aids Programme of Research in South Africa (Caprisa) put 889 women on the study over two years. They found that a vaginal gel containing the antiretroviral drug tenofovir was 39% effective in reducing HIV risk when used before and after sex. It was 54% effective when used more consistently, and also halved the incidence of genital herpes infections.
However, Caprisa 004 was a small trial and was not designed for licensure purposes. In order for the gel to be licensed for distribution and use, another study with more participants needed to be conducted.
Prof Helen Rees, executive director of the Wits Reproductive Health and HIV Institute, will be leading the Facts 001 study.
She said: “If we’re going to do licensure, we’ve got to demonstrate safety in thousands of women. We don’t have enough safety data yet. Through this new study we want to build up the body of knowledge of this gel so that we can put all of this data together and, assuming that we have got an effective product, apply for licensure.”
Rees said the objectives of the study are to confirm the Caprisa 004 results in larger and more diverse populations, as the initial study was only done on two populations in KwaZulu-Natal where the HIV incidence is extremely high.
The Facts 001 study will examine the effectiveness of the gel against HIV in different sorts of populations where the HIV incidence is lower, in other parts of the country.
Honouring the unsung heroes
“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,” said Derek Hanekom, deputy minister of science and technology.
Funded by South Africa’s Department of Science and Technology, the Department of Health and the US Agency for International Development, the Facts 001 study plans to enrol 2 200 women aged 18 to 30 years at seven trial sites across South Africa.
This will be the first South African-led team of scientists to conduct HIV research at seven centres, said Rees. She said international scientists collaborating with local peers usually led multi-site trials.
“We are very proud of the South African researchers who constantly prove that they are world-class,” said Hanekom. “We would also like to honour the women who are an integral part of these studies – they are the unsung heroes.”