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Trial fails dashing hope for Aids gel vaccine

Discussion in 'JF Doctor' started by ByaseL, Dec 15, 2009.

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    ByaseL JF-Expert Member

    Dec 15, 2009
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    Evelyn Lirri

    Aids researchers yesterday announced that an experimental clinical trial using microbicide gel has been halted after results showed women using it got infected at an almost similar pace as those not using it.

    The trial known as MDP 301 was conducted between 2005 and September 2009 by the Microbicides Development Programme in Uganda, South Africa, Tanzania and Zambia. A total of 9,385 women took part in the trials, of which 850 were from the Uganda site.

    Announcing the findings of the trials on the sidelines of the fifth Forum of the African Aids Vaccine Programme taking place in Kampala, health minister Stephen Mallinga said the clinical trial into a preventive HIV gel found no evidence that the vaginal microbicide PRO2000 reduces the risk of HIV infection in women.

    “The placebo-controlled trial found that the risk of HIV infection in women who were supplied with active PRO 2000 gel was not significantly different than women supplied with placebo gel. Although ineffective in providing protection, PRO gel its self was safe to use,” Dr Mallinga said.

    The women involved in the trial were divided in two groups. One group used the PRO 2000 gel, the name of the microbicide that was being tested-while the other group used the placebo gel that did not have the microbicide.

    The principal investigator of the Uganda trial, Dr Anatoli Kamali, said overall during the trial, there were 130 new HIV infections in the active gel group and 123 in the placebo group.
    “This showed to us that there was no effect of the gel in stopping the transmission of the HIV virus,” Dr Kamali said.

    Mr Kamali, however, did not say how many of the Ugandan women got infected, saying the detailed results would be released in 2010. The microbicide gel that was being tested was designed for women to apply in the vagina before sexual intercourse to prevent them from catching HIV, but they would use the gel along with other prevention interventions like condoms and counseling for safer sex.

    Some hope
    The results come on the heels of an increasing Aids infection rate in Uganda of about 130,000 new infections registered every year, a trend that has caused concern among public health experts.

    Reacting to the results, the Director General of the Uganda Aids Commission, Dr Kihumuro Apuuli, said behavioural change will be a key tool in Aids prevention in coming years. “The failure of this particular candidate does not mean that the microbicide trial will stop. The next generation of microbicide that will be tried is where antiretroviral drugs will be added,” Dr Apuuli said.

    Executive Director of the AIDS Vaccine Advocacy Coalition Mitchell Warren, said: “We’re disappointed to hear these results, since we always hope that such a trial will prove effectiveness. Yet we are confident that MDP 301, because it was so well implemented, provides vital information to help researchers and communities move forward in the search for safe and effective microbicides