The St. John's Medical College in Bangalore, YRG Care Chennai and the National AIDS Research Institute in Pune have been selected as part of a global research initiative to test the efficacy of microbicides in the prevention of HIV.
While in one trial project, the HIV drug Tenofovir will be applied as a gel, the other study will be carried out to assess usefulness of Cellulose Sulphate in preventing vaginal HIV transmission. The Screening Committee of the Ministry of Health and Family Welfare, government of India cleared the projects for the studies. The international non-governmental organization Conrad has granted Rs. 5 crore.
Uganda and South Africa are also conducting the Cellulose Sulphate trials along with the Indian research institutes, the St. John's Medical College in Bangalore, YRG Care Chennai and National AIDS Research Institute in Pune. The efficacy of Tenofovir study will be carried out to see how much the gel will be absorbed in the blood safety and suitability parameters.
For the first project, NARI in association with Bronx Institute, US is doing the phase II trials on the US FDA approved oral anti HIV drug Tenofovir, which is being used as a micro-biocides gel. This two-year trial has 200 women recruited.
Under the second project, St. John's Medical College, and YRG Care, have recruited 400 high risk women and the random phase III trials are on to study the results of Cellulose Sulphate application for HIV transmission.
Currently, there are more than 60 candidate microbicides in the pipeline but not one of these are available and medical scientists are hoping that within the next three years, the products could be licensed for marketing.
Sources informed that studies in the past showed that Tenofovir application as a gel in monkeys blocked transmission of Simian Immunodeficiency Virus (SIV) to HIV. But medical scientists opined that advanced studies were needed to determine if absorption of Tenofovir into the blood stream could be beneficial in enhancing the gel's effectiveness. In the NARI trial, the adverse and long-term side effects are also being studied.
The World Health Organisation has acknowledged use of microbicides as an effective agent against HIV. In fact this microbiocide gel is now seen as an option to AIDS vaccine because it has no spermicidal activity and would help the women protect themselves against the HIV transmissions, stated sources.