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Microbicide Carraguard in Phase III Study
  New Microbicides Give Women
More Control in Preventing AIDS

Wall St Jnl
December 13, 2006
Women are increasingly at risk of contracting the AIDS virus, and yet the most well-known method to prevent transmission during sexual activity is ultimately a decision made by the man.
Now, the days when male condoms are the best and easiest solution might be coming to an end, as four different forms of microbicides -- antiviral gels or creams that women can apply vaginally to prevent the human immunodeficiency virus -- are in final testing phases.
Experts say more than 60 microbicides are in various stages of development and testing, with some formulated as a pre-loaded diaphragm, cervical cap, sponge or vaginal ring releasing an active ingredient over time. The different microbicides include antivirals that use different methods of targeting the cells and virus.
"We know if there are more options, it's more likely to be used," said Anna Forbes, deputy director of the Global Campaign for Microbicides, a nonprofit organization based in Washington, D.C.
The first microbicide expected to complete testing is Carraguard, which is made from seaweed. It is being developed by the nonprofit Population Council in New York. Phase III trials are being conducted in three locations in South Africa and will be completed in March 2007.
Analysis of the data should be published by the end of 2007, and if Carraguard shows effectiveness at blocking HIV transmission, the council will seek the first regulatory approval from the South African Medicines Control Council. The council does intend to seek approval afterward, if the data justifies it, by the U.S. Food and Drug Administration.
"Our goal is to develop a product used by women in the countries hardest hit by HIV, and so we will work with regulatory entities in those countries," said Melissa May, director of public information for the council.
So far, Carraguard hasn't shown any significant side effects in testing on animals and humans, according to Ms. May.
Carraguard is being tested for use one hour before intercourse. Later testing and the subsequent versions of microbicides will be tested for use up to 24 hours or even on a monthly basis, according to Dr. Zeda Rosenberg, chief executive of the nonprofit International Partnership for Microbicides in Silver Spring, Md.
The efficacy of first-generation microbicides is expected to range from 40% to 70%, with the lowest rate averting 18% of infections; at 60% effectiveness, 35% of infections could be prevented. That could translate into countless lives being saved. More than 25 million people have died of AIDS since 1981, according to a recent report by the United Nations AIDS/World Health Organization. HIV causes AIDS (acquired immune deficiency syndrome) by damaging white blood cells and other defenses against infection.
Most versions of microbicides are coming from nonprofit organizations such as the Population Council and from small companies, such as Polydex Pharmaceuticals Ltd. of Canada. Pharmaceutical powerhouses such as Bristol-Myers Co., Merck & Co. and Johnson & Johnson are providing compounds for research, as well.
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