Report of the INDO- FRENCH meetings on traditional remarks on hiv aids on 25 -26th November 2004. National institute epidemiology, chennai India.

A two-day meeting under the indo- French initiative was held to discuss the various aspects of efficacy of siddha formulations administered by physicians of gandeepam for the treatment of hiv/aids like symptoms

November 25th ,2004

Dr .Mukesh kumar welcomed the members from both the French and Indian sida. Giving a brief background for calling such as meeting he explained that under the Indo -French initiative the Indian Council for Medical Research (ICMR) and the French ministry of Foreign. Affairs set us a committee of experts from both countries and members of the Gandeepam. Non Governmental Organization to examine the data presented by Gandeepam. On the use of "siddha Medicine " for the treatment of a Condition which Gandeepam healers consider to be equivalent to "AIDS" in the biomedicine classification of diseases. The Committee was co-chaired by Dr B.N Dhawan and Dr. Marc Lallement. Then Dr Dhawan (Former Director Central Drug Research institute, Lucknow) welcomed the participants on behalf of ICMR and Dr Marc Lallements (IRD) spoke on the objective of the meeting. Vr.V. Ramani (Gandeepam) Presented the Gandeepam projects, its therapeutic approach and the clinical data available to data. The Gandeepam presentation was followed by presentation of Dr. Nandini K.Kumar on the evaluation process of drug development from traditional remedies in India, Dr. M..D Gupte on the design and contact of clinical trials in his institute. Which supported the ICMR's studies in traditional remedies. Dr.Jean Pierre Aboulker, on the approach to clinical trail protocol design, and Dr.Sheela Godbole. On the screening methodologies for plant based drugs for HIV/AIDS. These presentations were followed by a general discussion between all participants and the representatives of the Gandeepam NGO.

November 26th, 2004

Dr. Vasantha Muthuswamy Sr. Deputy Director General of ICMR. The Indian coordinator for this meeting gave her introductory remarks. After that Hon'ble senator Guerry. Related his experience at Gandeepam as to how impressed he was about the effects of Gandeepam formulation. However he felt that scientific evaluation of the safety and efficacy of the same should be done before it could used on a mass scale. Then followed the presentation of the summary statement Vr.V.Ramani presented Gandeepams Planned activities. Which include the formal evaluation of his proposed therapeutic approach to treatment of AIDs. The experts discussed about the designing of appropriate research protocol, which could be used for scientific evaluation for Gandeepam's formulations.

Dr. jean Pierre Aboulker let the discussion of the various trail designs that could be envisioned in this setting. The consensus among scientists was that the initial evaluation phase should consist of an observational study. Designed and conduced according to current clinical research standards. Aiming at collecting primary safety and efficacy data in HIV positive persons seeking care through Siddha System of Medicine who are not in immediate need for antiretroviral therapy or prophylaxis treatment of opportunistic infections. The group insisted that the study should guarantee to the participants immediate access to antiretroviral therapy and Old (Opptunistic infections) prophylaxis or treatment if/ when needed during the study according to the international guideless for the management of HIV infection and national and international ethical guideless for the production of human subject in medical research.

Dr. Mukesh Kumar finally presented the status of ICMR Collaborations with French Research Institute and Dr. Vasantha Muthuswamy concluded the meeting by starting that with the recommendations of this meeting which this Indo-French Collaborative framework, ICWR and the French Ministry of Foreign affairs will set the agenda for the speedy evaluation of the safety and efficacy of Gandeepam siddha therapeutic approach to Hiv/Aids.

Recommendations

• Dr. M.D Gupte NIE will examine the data of 100 patients who ever given siddha medicine for HIV/AIDS like symptoms to calculate the Sample size for initialing an observational study.
• A protocol will be designed for such a trail, to be conducted by both Siddha practitioners as well as modern physicians by using respective parameters.
• The monitoring should be done an independent team from ICMR or joint Indo-French team.
• The patients should have a choice of opting for modern therapy when signed the informed consent.
• Access to currently available treatment for hiv/aids should be ensured for those who turn out to be HIV positive not responding to Siddha medicine.
  
  The meeting ended with a vote of thanks by Dr.Gupte.