A study initiated by the Department of Science and Technology (DST) to find out the safety and efficacy of a Siddha medicine for HIV is expected to complete within a year. Once trials are proved effective, the medicine which has already been administered on HIV patients at Tambaram Sanatorium, Chennai for several years could be widely used in government sponsored anti-retroviral treatment (ART) programmes, according to officials.

The single-blind, single-centre, two-year trial to evaluate the drug, HIVS 2004, is half on the way at the Bangalore-based Seva Free Clinic. The unique effort to find a remedy for HIV from the Indian Systems of Medicine (ISM) is scientifically supported and monitored by Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore as per the instruction of DST. The drug, HIVS 2004, is a unique herbal extract and mineral combination of more than 40 individual ingredients, revealed sources.

"The DST has asked the Jawaharlal Nehru Centre to initiate the study recognising the wide spread acceptance of the Siddha medicine administered in Tambaram as effective for HIV treatment. One year of the study has been completed and we can only say anything by the end of the two-year study," an investigator from Bangalore told Pharmabiz.

The drug has been administered orally to 30 HIV-1 sero-positive volunteers, for a period of 4 months, with no further administration thereafter. The primary outcome within two years is expected to be the stabilization or improvement of CD4 count, reduction in viral load and absence of apparent toxic side effects. A rapid reduction in viral load and stabilised or improved CD4 count in Highly Active Antiretroviral Therapy (HAART) for three to six months was also set as target for the study.

As a controlled intervention, the triple combination of zidovudine, lamivudine, nevirapine and an alternative regimen of stavudine, lamivudine, nevirapinen are also administered in equal number of volunteers for the entire duration of the study. The phase 1, 2 studies are conducted as per the standards set by World Health Organisation (WHO).

The patient recruitment for the project was executed by Samraksha, the HIV/AIDS unit of Samuha, a Non Government Organisation (NGO) working with vulnerable people to improve their quality of life in Karnataka. With the help of Skill share International, an organisation to promote sustainable development in partnership with individuals and communities in Africa and Asia, Samraksha currently provide services to over 3,000 people living with HIV/AIDS at counselling centres, respite homes, outpatient clinics and at home in various districts of the state, said sources.

It is to be noted that the drug, already being administered to HIV patients at Tambaram Sanatorium for several years is said to be effective in controlling the CD4 count, though the clinical proof was not documented. The Government of Tamil Nadu, through the Tambaram Sanatorium for TB patients and its comparatively new initiative under National Institute of Siddha (NIS), Tambaram, is also conducting studies on Siddha medicine for HIV along with its role as supporting system for main course of ART medication. The research has already proved that three effective Siddha drugs, Rasagandhi Mezhugu, Amukkara Chooranam and Nellikkai Lehyam, have immuno-restorative properties in HIV patients. These drugs are currently being used as staple drugs for all HIV patients attending Tambaram Centre, according to sources from NIS.