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'Anti-Aids gel' trial is stopped

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PostPosted: Thu Feb 01, 2007 1:39 pm    Post subject: 'Anti-Aids gel' trial is stopped Reply with quote

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Phase III Trials of Cellulose Sulfate Microbicide for HIV Prevention Closed

Arlington, VA – CONRAD, a reproductive health research organization, announced today that it has halted a Phase III clinical trial of cellulose sulfate – a topical microbicide gel being tested for HIV prevention in women – because preliminary results indicated that cellulose sulfate could lead to an increased risk of HIV infection in women who use the compound. The trial was being conducted in South Africa, Benin, Uganda, and India.

Simultaneously, Family Health International (FHI) has halted a second Phase III cellulose sulfate trial in Nigeria. Although the FHI trial did not detect an increased HIV risk associated with cellulose sulfate, the decision was made as a precautionary measure, given the preliminary results in the CONRAD trial. Cellulose sulfate (CS) was one of four microbicides currently in effectiveness trials for prevention of HIV and other sexually transmitted infections.

At this point, it is not clear why use of cellulose sulfate was associated with an increased risk of HIV infection in the CONRAD trial. The Independent Data Monitoring Committee (IDMC), an independent advisory group of experts overseeing the trial, will conduct a detailed review of the data to better understand the findings, and help determine any implications for other microbicide studies.

Dr. Lut Van Damme, principal investigator of the CONRAD trial, stated: “It was our hope that this product would have helped women in protecting themselves from HIV. While the findings are unexpected and disappointing, we will learn scientifically important information from this trial that will inform future HIV prevention research.”

The microbicide, also known as Ushercell, is a cotton-based compound developed by Polydex Pharmaceuticals, based in Toronto, Canada. Prior to beginning the Phase III efficacy trials, there were 11 earlier safety and contraceptive trials on cellulose sulfate involving more than 500 participants in Africa, India, and the U.S. -- none of which identified safety concerns.(SEE CLINICAL TRIAL SUMMARY)

Recruitment for the CONRAD Phase III study began in July 2005. The study was conducted in areas of the world where HIV risk is greatest, and where infection occurs primarily through heterosexual intercourse. Half of the participating women were given cellulose sulfate, and half a placebo gel, in a double-blinded randomized trial design. All participants received intensive HIV prevention counseling at each monthly visit and all women were given high-quality condoms free of charge. Participants received regular testing and treatment for sexually transmitted infections. Pregnant women were not included in the study.

Participants were admitted into the study only after receiving detailed information about the purpose of the study and the possible health benefits and risks. During this process, their understanding of the study was assessed prior to their signing a consent form. Each trial site is linked to local organizations that provide care for women who become HIV-infected during the trial. As part of the trial preparation, CONRAD set aside funding for women who become HIV-positive during the trial to ensure adequate health care, including HIV antiretroviral treatment when needed.

Jeff Spieler, Chief of USAID’s Research, Technology and Utilization Division, Office of Population and Reproductive Health said, “I am surprised and disappointed by these findings given the pre-clinical effectiveness and safety profile of CS, and its safety profile demonstrated in Phase I trials. I believe strongly that the field learns a great deal from every study, even those with disappointing results. The effort and resources that have been expended in terms of site and infrastructure development, training of clinical and laboratory staff, and community involvement activities will help move the field forward and pave the way to future studies.”

He continued, “I am also hopeful that one or more of the other microbicide candidates now in Phase III trials, and the next generation of products under development, will be shown to be safe and effective in helping to prevent HIV infection along with other behavioral interventions.”

“Developing new tools to prevent HIV – particularly for women – is an urgent priority,” said Dr. Henry Gabelnick, Executive Director of CONRAD. “We are committed to learning as much as possible from the trials of cellulose sulfate, and will use that knowledge to continue searching for compounds and collecting evidence to find a successful microbicide. Continued support for microbicide research is critical to our eventual success.”

'Anti-Aids gel' trial is stopped
HIV-positive woman in Kenya
African women are often unable to make men use condoms
Clinical trials of a new drug designed to help prevent women contracting the Aids virus have been stopped.

The World Health Organization said the drug, which uses a microbicidal gel, did not help the women and made them more vulnerable.

The tests were carried out on more than 1,300 women in South Africa, Benin, Uganda and India.

The WHO and the United Nations Aids agency said it was not clear why the product did not work.

A similar test in Nigeria has also been halted but trials of three other microbicides are still continuing.

The cellulose sulfate gel, based on cotton and made by Canadian company Polydex Pharmaceuticals, was supposed to release an active ingredient designed to kill HIV during sexual intercourse.

"This is a disappointing and unexpected setback in the search for a safe and effective microbicide that can be used by women to protect themselves against HIV infection," said WHO and UNAids in a joint statement.

Around 30 women had contracted HIV since the trial started in 2005, the AFP news agency quotes study co-ordinator Tim Farley as saying.

Scientists had hoped that microbicides could have a major impact in the fight against Aids, especially in Africa, where women bear the brunt of the disease.

They are being developed because it is often difficult for women to insist that men use condoms during sex.

"The closure of these trials is a stark reminder that drug development in general is a difficult and unpredictable process, and we must constantly bear in mind that the majority of drugs that enter the clinical trial process fail," said Zeda Rosenberg, the head of the International Partnership for Microbicides (IPM).

The International Aids Society said it was extremely disappointed at the setback, but that lessons would be learnt. "This will strengthen future microbicide research and increase our overall knowledge of how such compounds work," IAS President Pedro Cahn told AFP news agency.

Ushercell, which was "almost inadvertently ... invented" after being "originally designed for use in processing instant-camera film" (Nolen [2]
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PostPosted: Tue Feb 06, 2007 7:48 pm    Post subject: Reply with quote

This is a good site for AIDS drugs info:
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