Dr Roger Tatoud, the senior programmes Manager for the organisations that were conducting an HIV vaccine in Mazabuka, Zambia says only a few women contracted HIV in the process.
Reacting to a story published here on Monday that half the volunteers for theof the Microbicide Gel conducted by the Microbicide Development Programme in Mazabuka are feared to have contracted due to alleged failed efficacy of the drug, Tatoud says the story should be corrected.
He told the Watchdog Online that” It is very damageable and disrespectful for the women who participated in this study and learned a lot.”
He claimed that ‘The study was not testing a vaccine but a vaginal gel, nobody was exposed to HIV, and very few participants became infected.’
Tatoud, who is based in London said ‘This is a poor piece of journalism that does not honour the contribution of Zambia to medical progress.”
He however did not say whether willfully infecting people with viruses contributes to medical progress in Europe.
The drug called Gel was administered on HIV negative women as a preventive measure against contracting the virus in a trial to determine the effectiveness of the drug.
However, Programme Coordinator, Ruth Kasonde has declined to give details of the outcome of the trial to ZANIS in Mazabuka.
According to well placed sources, 1,340 HIV negative women were enrolled for the trial and that after 12 months it was discovered that nearly half of them had contracted the virus despite using the Gel.
The sources revealed that the results of the trial have since been submitted to the Microbicide Development Programme by the Medical Research Council of the United Kingdom.
Tatoud could also not respond to questions put to him by the Watchdog on whether the ‘few’ infected women will be compensated. The Watchdog also wanted to know from Tatoud whether participants were informed beforehand thepossible dangers of volunteering.
Tatoud’s auto email respnder said that h was on leave and could not answer despite having using the same email to contact the Watchdog a few hours earlier.
According to the story published earlier here, the Gel was being administered into the Vagina an hour before a sexual encounter.
The gel contains molecules that are intended to clump around HIV before it can penetrate the vaginal wall. However, the researchers found that the gel did not have such an effect as most of the women who used the gel contracted HIV during the study period.
The sources also revealed that next month the women who were under clinical trial would be briefed on the outcome of the research.
They further revealed that another research would be conducted targeting 60 women in Lubombo area in Mazabuka.
“This study will be different from the earlier one as it will focus on the acceptability especially that it is an ARV based microbicide trial,” the source s.
(http://www.mdp.mrc.ac.uk) Below is the report as published on the MDP websitewhich Tatoud says contains accurate information unlike what was published on the Watchdog:
HIV ‘prevention’ gel PRO 2000 proven ineffective
14 December 2009
The largest international clinical trial to date into a preventative HIV gel has found no evidence that the vaginal microbicide, PRO 2000, reduces the risk of HIV infection in women, scientists announced today.
This placebo-controlled trial involved 9,385 women at six research centres in four African countries and found that the risk of HIV infection in women who were supplied with PRO 2000 gel was not significantly different than in women supplied with placebo gel. Although ineffective in providing protection, PRO 2000 gel itself was safe to use.
A vaginal microbicide is a product intended for use before sexual intercourse to help reduce HIV infection, as it is clear that condom promotion alone has not controlled the epidemic. The gel was given to participants together with a package of prevention against HIV infection that included free condoms, counselling for safer sex negotiation and sexual health throughout the trial.
The trial, known as MDP 301, took place between September 2005 and September 2009 and was carried out by the Microbicides Development Programme (MDP), a not-for-profit partnership of 16 African and European research institutions. It was funded by the UK Department for International Development (DFID) and the UK Medical Research Council (MRC).
To date, no microbicide has been shown to be effective against HIV infection. This trial shows conclusively that PRO 2000 gel is of no added benefit, ending scientific speculation about its clinical importance.
MDP 301 Chief Investigator, Dr Sheena McCormack of the Medical Research Council said: “This result is disheartening; particularly in light of the results of a smaller trial sponsored by the US National Institutes of Health (NIH) which suggested that PRO 2000 could reduce the risk of HIV infection by 30 per cent. Nevertheless we know this is an important result and it shows clearly the need to undertake trials which are large enough to provide definitive evidence for whether or not a product works.”
Professor Jonathan Weber, co-Chair of the MDP Programme Management Board from the Division of Medicine at Imperial College London, said: “This is a disappointing result for the product, as the trial shows that it is not effective. However, the trial itself was very well designed and undertaken, so we know that the results are definitive.
“It is unfortunate that this microbicide is ineffective at preventing HIV infection, but it’s still vital for us as scientists to continue to look for new ways of preventing HIV. There are many research groups exploring different avenues to tackle HIV; it is a slow process, but we are making progress. Now that we know this microbicide is not the answer, we can concentrate on other treatments that might be.”
Dr Maureen Chisembele, Principal Investigator of the Zambian site, said: “In Sub-Saharan Africa, nearly 60 per cent of all people living with HIV/AIDS are women. Many are highly vulnerable to HIV despite the fact that they are faithful to their partners. The women will be disappointed by this result as they really liked the gel and hoped it would work.”
A South African trial participant commented: “Even though the gel proved not to be effective, we played a role in the fight against HIV. We learnt a lot about caring for ourselves, such as using condoms. We also learnt to encourage others to test for HIV and we gained confidence in helping those who were already infected.”
The trial participants are being informed of the trial outcome. The full results will be submitted for presentation at international conferences in 2010, as well as for publication in a peer-reviewed scientific journal.
The gel used in the study was provided by Endo Pharmaceuticals, a specialty pharmaceutical company with headquarters in Chadds Ford, Pennsylvania, USA.
Notes for editors:
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