By Prashant K. Nanda, IANS
New Delhi : India has successfully completed phase two trials of a neem based microbicide gel for women that promises to help prevent transmission of HIV/AIDS.
“It will be a gel-based microbicide to be used in the vagina to stop new HIV/AIDS infections,” said Nomita Chandhok, deputy director general of the Indian Council of Medical Research (ICMR).
“It’s purely an indigenous product. We have found success in phase two of the trials at the National AIDS Research Institute (NARI) in Pune. Fifty high risk but HIV negative women used it regularly for six months and we are happy at the outcome,” Chandhok told IANS.
Microbicides are a compound with the ability to protect against sexually transmitted diseases.
She said the microbicide named Praneem is a herbal composition and researchers are optimistic about its future.
“During animal trials we tested the microbicide on rats and rabbits among others. The gel was put inside their vagina and researchers recorded the toxicological effect of the compound,” she said.
“The third phase of the trials will begin very soon and its result can be expected in 18 months.”
After animal trials, the first phase of human trials check the toxicological effect of the drug, like itching and swelling. The sample size could be as small as 10 people.
Phase two of the clinical trial takes into account more individuals than the previous phase and monitors side effects of the product.
In phase three, the trials are generally conducted in multiple sites and amongst multiple risk groups. A favourable result leads to its application for licensing and mass production.
According to Chandhok, the ideal sample size in the last stage should not be less than 2,000.
India is home to 2.5 million HIV/AIDS patients and nearly 40 percent are women.
“Women are more vulnerable to AIDS but we don’t have anything specific for them to counter the disease. Staying away from sex and change in behavioural changes are good but we need something that can prevent fresh infections,” Chandhok said.
Indian experts said the world’s first microbicide gel for women with an AIDS drug has successfully crossed phase two trials in three places, including in India, but that was entirely a US project.
“Though India was one of the sites to conduct clinical trials yet the project was entirely of the United State’s National Institute of Health (NIH). Praneem is entirely an Indian effort and the brainchild of a scientist named G.P. Talwar,” she added.
Talwar is a Delhi-based scientist working in close collaboration with ICMR.