http://www.cnn.com/2003/HEALTH/06/15/australia.aids.gel/index.html

Human trials for AIDS barrier gel

By CNN's Grant Holloway
Monday, June 16, 2003 Posted: 1:24 AM EDT (0524 GMT)

Women in poorer countries are more vulnerable to contracting HIV. Story Tools RELATED • HIV epidemic could triple by 2010  • Proteins key to replication of HIV  • Interactive: AIDS statistics   • Interactive: How HIV infects cells   • Gallery: AIDS in Asia    • Special report: 20 years of an epidemic

SYDNEY, Australia (CNN) -- An Australian company may soon begin human trials for an anti-AIDS gel which could dramatically reduce the spread of the virus in developing countries.

Melbourne-based Starpharma is seeking approval from the U.S. Food and Drug Administration (FDA) to trial the gel which has proved 100 percent effective in preventing HIV and other sexually-transmitted diseases in primate trials.

The gel -- if human trials prove successful -- would be particularly targeted at women in poorer nations, giving them cheaper, easier personal control over HIV prevention.

A report by the Rockefeller Foundation into HIV prevention, released earlier this year, estimates up to 2.5 million lives could be saved over three years if such a product was readily available.

In animals trials using macaque monkeys, a single application of the VivaGel product proved 100 percent effective against the monkey version of HIV as well as animal versions of genital herpes and chlamydia.

More than 5 million people are infected by HIV each year, 1.8 million of them women.

Starpharma chief executive officer Dr John Raff told CNN Monday that if FDA approval is granted smoothly then phase-one human trials of the product could begin in Australia by the end of this year.

This would then be followed by a second 12-month trial involving at least 8,000 women with a possible prescription-only product available in three years' time. It would be another two years after that before an over-the-counter type product could be distributed.

Raff said VivaGel was a "first of its type" product which could set a precedent for the development of other disease treatments in years to come.

AIDS has the potential to devastate the economies of struggling nations.

"A lot of people will be watching very carefully what the FDA will do," Raff said.

Starpharma had enough funding to continue its work for the next 30 months and was confident of gaining additional external finance from governments or AIDS foundations to fully realize the potential of its product, he said.

A lot more international money and effort was now being put into developing preventatives for HIV/AIDS than cures, including a $15 billion U.S. program to combat AIDS in Africa and the Caribbean which came into effect last month, he said.

And the development of a cream or a gel to help prevent HIV transmission was boosted in late March by a $60 million donation from the Bill and Melinda Gates Foundation.

The money was donated to the International Partnership for Microbicides (IPM), a non-profit organization set up to promote the development of low-cost HIV/AIDS preventions.

Microbicides are gels, films, sponges or other products applied directly to the skin to help prevent the spread of disease.

The IPM says the development of these types of treatments is downplayed by large pharmaceutical companies because they are not big money-spinners.

Looming crises

But microbicides are particularly useful for women in poorer countries as they give them more control in helping prevent disease, particularly in cultures where condoms are a male-dominated product.

Women are also more vulnerable to contracting HIV from a single sexual encounter.

Countries such as Myanmar and Papua New Guinea face looming AIDS crises of a scale similar to those seen in Africa because of a lack of preventative measures.

A recent Australian government aid report says the working population of PNG could be cut by 38 percent by 2020 if infection rates follow those seen in Zimbabwe. (PNG on the brink)

In Myanmar it is estimated that as many as 1 in 50 people has HIV with the disease spreading rapidly among the general population from high-risk groups such as prostitutes and intravenous drug users.

At the end of last year, 42 million people were infected with AIDS and by 2010 it is estimated a further 45 million people will be infected.