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Clinical trials on microbicides

R. Sujatha

Pilot project in city to test efficacy of HIV prevention drugs Phase 3 trials have been taken up in sub-Saharan Africa, India and parts of southeast Asia.

CHENNAI: The third phase of clinical trials on microbicides will be done on women in the city once the Central Government approves the proposal.

Tamil Nadu has been chosen because of the reported high incidence of HIV/AIDS. YRG Care, an organisation working with people with HIV/AIDS, will conduct the trials on 100 vulnerable women after the Central Government's concurrence.

The fifth international conference on AIDS, to be held from October 20 in Chennai, being represented by scientists, researchers and representatives from non-government organisations will discuss the issue and provide information on microbicides.

World over, the phase 3 trials have been taken up in developing countries such as sub-Saharan Africa, India and parts of southeast Asia. Microbicides help to prevent HIV and sexually transmitted diseases by killing or immobilising the infecting virus. It creates a thin film in the vaginal and rectum cells and blocks infection. Microbicides are not available on the market yet but are only being tested on humans. Use of microbicide does not eliminate the use of condoms, however, says Suniti Solomon, director of YRG Care.

Dr. Solomon called for promoting microbicides as health products that would prevent any type of infection.

The first two phases aimed at finding out how safe microbicide was. In the second phase, around 300 participants underwent the trial for 6-18 months to find out whether the product was acceptable. The third phase, where participants will use the products for 1-2 years, will study the effectiveness of the product. Every participant will be given the microbicide only after consent.

Though participating in a trial does not increase a person's risk of becoming infected, women who are unable to insist on the use of condoms could be at risk. During the trial, participants will receive counselling and regular screening and treatment for STD.

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