Anti-HIV Gel Boosted for Clinical Trials
October 25, 2005
VivaGel, an Australian-invented anti-HIV product, will be tested on about 200 men and women in Thailand and Australia beginning next year. Designed for application before sex to prevent HIV and herpes, the gel will be tested for safety in four human trials, according to Mark Sullivan, chief operating officer of a consortium recently awarded $26 million Australian ($19.7 million US) to accelerate VivaGel's development.
Laboratory studies have shown that VivaGel binds to a protein on the surface of HIV, blocking it from infecting human cells. Sullivan said a preliminary study last year, in which 24 healthy Adelaide women applied the gel vaginally for seven days, found the product had a good safety profile.
Next year's trials are Phase I studies that will be conducted over 14 days on volunteers, including healthy women, men, sexually active women and women with HIV. The consortium behind the development of VivaGel includes Australian biotech company Starpharma, which invented it; Melbourne's Burnet Institute, the National Center in HIV Epidemiology and Clinical research at the University of New South Wales; and the Red Cross AIDS Research Center in Bangkok. The US National Institutes of Health gave the consortium the grant to develop VivaGel. It is one of the largest grants ever given to Australian medical research.
"It looks theoretically a very interesting approach to blocking the virus' ability to bind to the receptors but they're a long way from getting there yet," said Melbourne University's Roger Short, whose laboratory studies some years ago showed lemon juice immobilizes sperm and kills HIV.
Even if VivaGel proves 100 percent safe, further trials involving many more people will be necessary before the product can be licensed.
Australian Associated Press
10.14.05; Janelle Miles
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.