R.I. doctors testing gels to fight AIDS

THE GEL in this applicator, CaraGuard, is one of several microbicides that could help protect against HIV. 'We're talking about products that sell for pennies a dose,' says Anna Forbes, deputy director of the Global Campaign for Microbicides. /
THE GEL in this applicator, CaraGuard, is one of several microbicides that could help protect against HIV. 'We're talking about products that sell for pennies a dose,' says Anna Forbes, deputy director of the Global Campaign for Microbicides. /

Dr. Kenneth Mayer and his staff at Brown University’s AIDS Program have spent more than two decades working to slow the spread of the virus in Providence, and soon, research they have conducted here might save millions of lives around the globe.
Early safety studies on four topical gels being developed to protect women against HIV infection were conducted by Mayer’s team and other researchers at The Miriam Hospital over the past decade. Three of the drugs are now in clinical trials, and one could possibly be on shelves as soon as next year.

Development of a microbicide for HIV would be a major coup for health officials battling AIDS in the United States and especially in Africa and Asia – continents where the pandemic is spiraling out of control, Mayer said.
“It may not end the AIDS epidemic tomorrow, but if it could slow it down, that would be remarkable,” said Mayer, who is also a professor of medicine and community health at Brown and an infectious disease specialist at Miriam.
Worldwide, women make up more than half of all people living with HIV, the virus that causes AIDS. More than 17 million women are currently infected with HIV, and about 8,000 new women are infected with HIV every day. In the United States, only cancer and heart disease now kill more women each year than AIDS, according to the Centers for Disease Control and Prevention.
Development of a topical HIV microbicide could prevent 2.5 million new HIV infections over three years, according to a conservative mathematical modeling estimate done by the London School of Hygiene and Tropical Medicine, said Anna Forbes, deputy director of the Washington, D.C.-based Global Campaign for Microbicides, speaking in advance of a two-day symposium on slowing the spread of HIV in women held at Brown from May 4 to 6.
Three microbicides have made it to Phase III clinical trials, including two that had Phase I trials in Providence. Carraguard, a gel currently being tested in South Africa, is expected to complete its clinical trial late this year or early next year. BufferGel, which had Phase I trials at Miriam and is currently being tested in Africa and elsewhere in the U.S., is expected to complete its clinical trial in 2009. Pro2000, another gel that had Phase I trials in Providence and is now being tested in Africa, is also expected to yield results in 2009.
No pharmaceutical companies are investing yet in any of the clinical trials, which are being entirely funded by governments and philanthropies, Forbes said. As an example, Carraguard is being developed with backing by the Population Council, the Bill and Melinda Gates Foundation and the U.S. Agency for International Development. BufferGel is being developed by a small life sciences company in Baltimore called ReProtect that was formed by researchers at Johns Hopkins University to attract venture capital for the project, she said.
All of the Phase I trials that Brown researchers conducted at Miriam were funded by grants from the National Institutes of Health, Mayer said.
“Virtually all of the microbicide research to date has been done by either NGOs or by groups of academic scientists who started working on this just because they thought it was a problem and because they thought, ‘There’s got to be a way to do this,’ ” Forbes said.
Large pharmaceutical companies have yet to jump into HIV microbicide research because developing the drugs is expensive and risky, and because microbicides don’t promise to be wildly profitable once developed, she said.
Rather, Forbes said, pharmaceutical firms will probably bid to buy the rights to HIV microbicides once they are already developed and approved by government regulators.
“We’re talking about products that sell for pennies a dose, so that there’s not an immediate profit incentive to do it,” Forbes said. “There’s also the perception that, because it’s a brand-new type of product – because it’s something for which we don’t even have proof of concept yet – why bet on the horse race when you can buy the horse, you know?”
Federal funding for the development of an HIV microbicide also has been limited by the political disagreement over whether abstinence should be advocated as the primary prevention in the global battle against AIDS, Forbes said.
The debate is costing human lives, in Forbes’ opinion, because public health data show that abstinence promotion has almost no long-term impact on the pandemic.
Another consequence of the push towards promoting abstinence is it has given governments with skyrocketing HIV infection rates – particularly among women – an excuse to keep from having to deal with the epidemic, Forbes said.
“If you’re in a country where up to 25, 30 percent of women of child-bearing age are already HIV positive, you’re looking at a phenomenal pandemic, the scope of which we can’t imagine in this country,” she said. “For an impoverished government that’s already got more on its hands than it can deal with, the idea of denying having to deal with AIDS is very appealing, because you don’t have the money to do it anyway.”

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