Botched microbicide trial scares Ugandans from Thai vaccine

Kampala- Uganda (PANA) -- After learning that the largest international clinical trial involving 9,385 women in four African countries into preventative HIV gel f ailed, with participants getting infected at the same rate as out of the experim e nt, the Ugandan public is now resentful to enroll for any further trial other th a n that aimed at curing the dreadful disease.
â?It is disturbing to learn that victims of this disastrous trial are left to s uffer without any compensation, not even providing them with free anti-retrovira l treatment, they have to foot the bills themselves,â? Joel Sentamu, 38, an engin eer lamented.
â?To me, such results are an eye opener on the choices we make.
I will not enco urage anyone to engage in any trial which is not aimed at finding a cure,â? Sent amu stressed in Kampala.
The microbicide gel that was tested was designed for women to apply in the vagin a before sexual intercourse, to prevent them from being infected with HIV but th e y would use the gel along with other prevention interventions like condoms.
Code named Microbicides Development Programme (MDP) 301, the botched trial was c onducted between September 2005 and September 2009 in Uganda, South Africa, Tanz a nia and Zambia.
A total of 9,385 women took part in the trials, of which 850 were from Uganda.
Shortly after news of a botched trial, there came news of a vaccine from Thailan d being introduced in Africa.
Ugandan Health Minister, Dr.
Stephen Malinga, broke the shuddering news on the f ringes of the fifth Forum of the African AIDS Vaccine Programme on Monday, sayin g the clinical trial into a preventive HIV gel found no evidence the vaginal micr o bicide PRO2000 reduces the risk of HIV infection in women.
â?The placebo-controlled trial found the risk of HIV infection in women who wer e supplied with active PRO 2000 gel was not significantly different from women s u pplied with placebo gel,â? Malinga observed.
Cognisant of the fact that participants consented knowing what they were experim ented on, a lawyer, Moses Ntende noted that the stakeholders of the trial were l e ft with a moral obligation to handle, in terms of some compensation.
â?Results may be disastrous but the scientists have enriched their knowledge an d do not think they are to just give.
They are already back in the laboratories, improving the product, courtesy of the people in the trial,â? Ntende noted.
In an interview with PANA, UNAIDS Chief Scientific Adviser, Catherine Hankins, c onceded, saying all nations and stakeholders undertaking any health-related tria l s have a moral obligation to handle the consequences, be it positive or not.
â?All nations and agencies involved in these trials have a moral obligation to take care of the victims,â? Hankins stressed, declining to specify how the victi ms in the four poor countries where trials were done will actually be helped as t he disease takes its toll on their lives.
A non-profit partnership of 16 African and European research institutions, the t rial was funded by the UK Department of International Development (DFID) and the UK Medical Research Council (MRC) Julie Naiga, a 26-year old mother of one, is a victim of the ruined trial that s aw 850 Ugandan women divided in two groups.
One group used the PRO 2000 gel - th e name of the microbicide that was tested - while the other group used the placeb o gel that did not have the microbicide.
The principal investigator of the Ugandan trial, Dr.
Anatoli Kamali, confirmed f ailure, saying overall during the trial, there were 130 new HIV infections in th e active gel group and 123 in the placebo group, showing â?that there was no effe ct of the gel in stopping the transmission of HIV virus.
â?The infections did come as a result of the gel not working; instead, particip ants got infected due to not observing the ABC approach,â? Kamali said, dismissi ng allegations by victims of the trial.
Asked about any compensation for victims over the futile trial, he said: â?ther e is no compensation to any of the participants who got infected during the tria l .
â? According to him, â?The trial was done observing ethical standards and guidelin es set up by both international health authorities like WHO, UNAIDS and local au t horities.
â? Director General of the Uganda AIDS Commission, Dr.
Kihumuro Apuuli, held that â ?behavioural change remains a key tool in AIDS prevention in coming years.
â?In the absence of any efficacious cure or vaccine, the only vaccine available to everyone at no cost is behavioural change.
People have to abstain till marri a ge and once married, they must exercise fidelity,â? Apuuli said.
He hastened to note, however, that â?failure of this particular candidate does not mean the microbicide trial will stop.
The next generation of microbicide tha t will be tried is where antiretroviral drugs will be added.
â? Executive Director of the AIDS Vaccine Advocacy Coalition, Mitchell Warren colla borated this, saying, â?we are disappointed to hear these results, since we alwa ys hope that such a trial will prove effective.
â?Yet we are confident of MDP 301, because it was so well implemented, provides vital information to help researchers and communities move forward in the searc h for safe and effective microbicides.
â? To many in Kampala, the suffering victims of the botched microbicide trial are n ow exposed to undermines efforts to introduce the Thai Vaccine, which is reporte d to have scored a 31.
2 per cent efficacy.
â?Yes, we are faced with a challenge that attracts participants in the Thai vac cine trial after the microbicide trial did not give the desired results.
But we w ill have to invest more effort in educating the public,â? said Dr.
Potiano Kalee bu, Head of Uganda Virus Research Institute.
â?In the Thai Vaccine trial, we will target high risk population groups like th ose engaged in prostitution and the married, where a high infection rate is bein g recorded since 2007.

17 december 2009 19:52:00




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