Microbicide gel with AIDS drug marks vital successFebruary 25th, 2008 - 9:34 pm ICT by admin
New Delhi, Feb 25 (IANS) The world’s first microbicide gel for women with an AIDS drug has successfully crossed Phase II trials in three places including India, holding out promise of an effective method to prevent transmission of the deadly health condition. “The microbicide with Tenofovir has crossed the wider safety test during the Phase II trials. It’s really a very good development and brings with it hope for millions of women across the globe,” Nomita Chandhok, deputy director general of the Indian Council of Medical Research (ICMR), told IANS.
There are nearly 20 million HIV/AIDS women patients worldwide.
Microbicides are a compound with the ability to protect against sexually transmitted disease. With a combination of an anti-retroviral drug (AIDS drug), it will help protect the women from contracting HIV/AIDS.
The microbicide is in a gel form to be applied inside the vagina.
“The Phase III trials will be conducted among volunteers across the globe and the final results are expected in around a year-and-a-half,” Chandhok said.
During the Phase II trials, scientists at the National AIDS Research Institute (NARI), Pune, an ICMR regulated institute, conducted the tests on 100 non-HIV women.
“The women are in the reproductive age group and had used the gel regularly, both before and after sex. The gel passed the wide safety tests very well. The safety profile among these volunteers was good and it seems to be a widely acceptable gel,” Chandhok said.
N.C. Jain, another ICMR scientist, said: “Though we don’t have a ready-to-use product now but the future looks bright.”
Nearly 1,000 researchers and scientists from several countries, including around 300 from the US, are in the capital to participate in a microbicide conference.
With first-generation microbicides like Carraguard and Ushercell having failed during clinical trials, scientists are now keeping their fingers crossed for achieving a breakthrough with Tenofovir.
The clinical trials of the microbicide with Tenofovir were carried out in Pune and two other places in the US. The third phase is likely to be carried out on 5,000 women.
The Phase-II (B) trial was also carried out on 1,000 women, mainly from South Africa, the most AIDS endemic country in the world.
Experts said that over 85 percent of those who volunteered for the study were happy with it and only 11 percent were not. At least 40 percent said it was easy to use. “Overall we can say the response was good,” said another scientist.
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