NewsfeedVaginal Microbicide Trial Failed
Clinical trial on the effectiveness of the anti- HI virus gel
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“Women will be disappointed by this results as they really liked the gel and hoped it would work.”
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A clinical trial of the effectiveness of the anti-AIDS virus gel, Microbicide PRO 2000 – a topical compound that can be used to protect against STDs during rectal or vaginal intercourse – has shown no evidence that it can reduce risk of HIV infection in women.
The study, which involved more than 9000 women in four African countries, has revealed no difference in the rate of HIV infection between women given the PRO 2000 gel and those on placebo gel during the trial.
The Microbicide Development Programme (MDP 301) a joint project by non-for-profit UK government funded Medical Research Council (MRC) and the Department for International Development (DFID) has sent a clear message of demand for products that woman could use to protect themselves from the HIV infection.
The gel was administered to HIV negative women as a preventive measure against contracting the virus to determine its effectiveness. But 12 months after, there are fears that volunteers on the trial have contracted the HI virus showing that gel is not efficacy.
According to a joint UNAIDS-World Health Organisation (WHO) statement, the result is disappointing but the team study should be applauded for having implemented such large, scientifically rigorous, ethically-sound trial that engaged the communities in which it was conducted in an exemplary, participatory way.
Microbicide Development Programme Principal Investigator for Zambia, Dr. Maureen Chisembele say, “Women will be disappointed by this results as they really liked the gel and hoped it would work.”
And Centre for Infectious Disease Research in Zambia (CIDRZ) director Dr. Jeffrey Stringer, whose organisation is also involved in microbicide research, said that the Research Ethics Committee (REC) of the University of Zambia had approved the research, and that it must have been conducted to a high ethical standard.
CIDRZ is also involved in vaginal microbicide research in Zambia, and had earlier reported the results of a study that suggested the PRO-2000 product was partially effective in preventing HIV acquisition.
In Zambia, MDP 301 research center in Mazabuka involved 1,340 HIV negative women on the trial, after a year it is discovered that approximately 4 per cent of the women had contracted the AIDS virus despite using the gel.
The trial results have since been submitted to the Microbicide Development Programme (MDP) by the Medical Research Council (MRC) of the United Kingdom.
But Mazabuka district area chief, Mwanachingwala has since called on the Zambian government to ban all clinical trials being carried out by the MDP in his area.
He ordered the project to immediately devise a compensation scheme for the women who were engaged.
And Mazabuka district MDP Community Liaison officer, Kennedy Mundia told State-owned Zambia News agency that: “Calls to suspend the trials is counter productive because his organisation is in hurry to find a remedy for HIV/AIDS.”
Further research would be conducted targeting 60 women in Lubombo area in Mazabuka southern, Zambia.
They say 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 MDP study was conducted in six research centers across four African countries- South Africa, Tanzania, Uganda and Zambia.
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.
Zambia is among the country in southern Africa highly affected by HIV/AIDS.
Currently, there are over 30 different types of microbicide gels in development around the world. Some work by forming physical barriers against infection while others by making the vaginal or rectal, environment less susceptible to infection.
For some scientists, the holy grail of microbicide development is discovering a microbicide that protect against STD infection while allowing pregnancy. This type of microbicide could be a miracle for women who wish to protect themselves from the possibility of an STD, but want, or need, to keep having children.
4 Comments
The results of the vaginal microbicide study come as no surprise to African researchers. It was folly to embark on this study without assessing the cultural aspects on having sex. We Africans like dry sex and have sex several times a week including twice or thrice a night. Who on earth thought that Zambian women will use the vaginal gels several times? We use herbs to dry the vagina. Lubricating the vagina will have a ‘slip up’ effect. Furthermore our small homes will have to have a large container with gels and as with condoms the risk and temptation to sell it and eran monies is always there, thus not being used for the purpose it was meant for. Western researchers must in future learn about local cultures before embarking on these very expensive studies which are a non-starter from the beginning. James MWansa
I am a student of one of the anthropologists attached to the trial. He found that women very much liked the gels, contrary to what James wrote. He further argues that the whole dry sex thing is a myth.
Rather than contract a man from Zambia, I suggest that women’s preferences differ across the continent. After all, it’s a huge area!
RK
You are obviously biased since you are attached to the trial and thus have conflicts of interest. This is a basic flaw with your argument. I entirely agree with James’s comments. It is so important that local cultural issues are discussed at length before anthropologists get involved in these trials. I understand there were no such pilot studies conducted before rushing to do the studies.
Important lessons are to be learnt here.
Jeremiah
THIS TO ME SEEMS LIKE A VERY UNETHICAL STUDY. WHY WASN’T IT CARRIED OUT IN AMERICA OR ELSEWHERE. HIV IS THERE TOO. TAKING ADVANTAGE OF IGNORANT AFRICAN WOMEN WHO PROBABLY DIDN’T NOT CONSENT TO THE STUPID TRIAL, AND WERE PROBABLY TOLD THAT THE GEL WAS CURE. THE WEST NEEDS TO STOP TREATING AFRICANS LIKE ANIMALS. USE YOUR LABS FOR SUCH RESEARCH. YOU HAVE MADE INNOCENT WOMEN HIV POSITIVE NOW. THE ADVERTS WERE VERY DECEIVING AND THE MONEY OFFERED WAS ENTICING TO POOR LADIES. 6MILLION KWACHA! I’M NOT HAPPY AT ALL!!! ZAMBIANS WAKE UK. THE MUZUNGU SYMDROME HAS TO END!!!
