Dubbed the FACTS 001 study, the clinical trial seeks to expand on the findings last year of an initial Phase IIb study, CAPRISA 004, which investigated the concept of using a product for AIDS treatment in HIV prevention. Testing an antiretroviral drug known as Tenofovir, in a microbicidal gel formulation among 900 women, where half received the actual study gel and the other a gel not containing Tenofovir, the study found that the product can reduce HIV infection by 39% when used before and after sex. The research also went on to show ‘ by sheer coincidence as the study was not meant for the purpose – that the Tenofovir gel can protect women from contracting herpes, by about 51%. This Phase III study, under the guidance of three eminent women scientists, will be led by Professor Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute, who explains the need for a secondary study.
‘Before CAPRISA released their results, they summoned together many of South Africa’s best HIV prevention researchers and a discussion was held. It was to say: If CAPRISA comes in positive, what should we do as a country because we know that the study wasn’t decided for licensure? But we need to confirm it. If there’s a positive result we need to get into the field to confirm this as quickly as we possibly can. So, we agreed that that was what we were going to do’, Professor Rees says.
Already working on the knowledge that the Tenofovir gel is effective against HIV prevention and herpes, Rees says researchers are hoping that the result in the secondary study will be more significant. The finding could lead to the licensure of the Tenofovir gel as the first ever microbicide against HIV infection and herpes.
‘The study objectives are to confirm the CAPRISA 004 results in larger and more diverse populations. Remember that the CAPRISA study was only done in two populations in KwaZulu-Natal where the incidence is extraordinarily high. So, you need to also demonstrate that this gel is going to work in different sorts of populations where the HIV incidence is lower, which is the case in many parts of the country. We want to look at the effectiveness of the gel against HIV and, this time, we want to design the study to specifically also look at whether it’s effective against herpes because the CAPRISA study wasn’t actually designed specifically to look at that, although they found this as a finding when they subsequently analysed the results. Very importantly, if we’re going to do licensure, you’ve got to demonstrate in many thousands of women, safety. We don’t have enough safety data yet. What we want to do with this data is to build up the body of knowledge of this gel so that we can put all of this data together and, then, assuming that we have got an effective product, apply for licensure’, says Professor Rees.
The Department of Science and Technology has thrown its weight behind the FACTS 001 study, which it is funding to the tune of R70 million over the next three years. Deputy Minister of Science and Technology, Derek Hanekom, is upbeat about the research. He also reiterates government’s commitment to the AIDS response.
‘We are past the stage of denial. We are in the stage of effective treatment, of cracking it, of tackling it head on. And we’re doing it vigorously, led by the Minister of Health. We would look forward to the outcome of this second stage trial. We have a high level of confidence that it will confirm the results. And we are ready’¦ we are poised’¦ should this trial confirm the effectiveness of this gel, it will be put on the market as soon as possible’, says Hanekom.
The study has also garnered support from the United States government’s agency for AIDS, USAID, which is investing about R120 million into it over three years. America’s ambassador to South Africa, Donald Gips, says the Tenofovir gel ‘offers a promising new tool to prevent the spread of HIV/AIDS, as it is clear that treatment alone can never end the epidemic’. Gips says as a prevention mechanism for women, a population most at risk of HIV infection, a successful microbicide is crucial.
‘We will never treat our way out of this epidemic. We have to figure out how to prevent new people from getting the disease. And that will require a comprehensive set of prevention measures. I’m hopeful that the Tenofovir microbicide will prove to be a significant part of that tool-kit. Women, and particularly young women, bear the brunt of the HIV/AIDS epidemic. And the one figure that always stuns me is that 1 in 3 women aged 20 ‘ 34 years old in South Africa are infected with HIV’, he says.
Researchers will start recruiting participants into the study as from early July. About 2 200 women will be enrolled for a start. To be eligible you need to be a non-pregnant woman between the ages of 18 ‘ 30, be sexually active, with an HIV-negative status.