U.S. Trial Set for New Anti-HIV, Anti-Herpes Gel

TAMPA, Fla. — VivaGel, an experimental microbicide gel that may block HIV and the herpes virus, is being clinically tested on 40 sexually active women at the University of South Florida in Tampa and the University of Puerto Rico in San Juan, Puerto Rico.

"We have already conducted clinical trials on the safety of VivaGel in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations," said Dr.Jackie Fairley, CEO of Starpharma, the Australian company that developed the product. "This study, in addition to the usual safety data, will collect valuable information regarding the product’s use and acceptability in the consumer setting."

Starpharma researcher Dr. Jeremy Paull said the active ingredient in VivaGel is dendrimer, a molecule that binds itself to the viruses and prevents them from infecting healthy cells. Dr. Paull said the gel's ability to prevent genital herpes was particularly positive.

Previous tests on lab animals have shown that VivaGel inactivates the HIV virus and another virus responsible for genital herpes. A clinical test on men in Australia has indicated that the active ingredients in the gel were not absorbed into the bloodstream after topical application.

The new test will involve subjects applying gel — either VivaGel or a placebo — to their vaginal wall twice a day. The safety of VivaGel will be measured against the placebo by laboratory tests and clinical examination of the subjects.

"Microbicides seem to be a great idea," Adult Industry Medical Health Care Foundation Co-founder Sharon Mitchell told XBIZ. "I would love to see more used. I think that if we could perfect a product, it would be perfect for the adult industry, as long as it isn't cosmetically unsavory. It's all about barrier protection, and if people won't use condoms and we could get a nice clear microbicide, it would be ideal for this industry."

VivaGel is still in the experimental testing phase and there is no word on commercial availability.

For more information, visit the Starpharma website.

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