A collaboration between Mount Sinai School of Medicine (MSSM), the Foundation for Integrative AIDS Research (FIAR, a US-based not-for-profit) and Gandeepam, a non-governmental organization (NGO) located in Kilavayal, Tamil Nadu. South India is being developed in order to identify potential treatments from the Siddha tradition that may slow HIV disease progression or be helpful in managing opportunistic infections.
The aims of the current project include: 1) to strengthen linkages and to develop methodologies for the evaluation of professional working relationship between MSSM, FIAR and Gandeepam; 2) to ascertain the current ability to comprehensively evaluate Siddha interventions for managing HIV disease; 3) to provide expertise, knowledge sharing, training and insight into clinical trial design and conduct, IRBs, patient consent and other relevant aspects of clinical design; 4) to assure adequate infrastructure needs for diagnostic, safety and treatment evaluation; 5) to establish a case series and preliminary phase I evaluation of current methods for managing HIV disease from the Siddha perspective; 6) by the end of the project, a five-year application develop a long term research agenda along with, as consensus between team members develops, plans for phase II/llI clinical studies to evaluate intervention efficacy; and 7) to explore and develop intellectual property and/or other commercial development issues, with respect to U.S. and Indian law and principles of fair trade. The collaboration will support capacity building efforts which will sustain linkages within and between Mount Sinai's and FIAR's expertise in clinical trials and comniunity/infrastructure development and the Gandeepam Project, which serves a rural, very poor population. It is an NGO rooted in the ancient Indian traditional medicinal system known as Siddha, originating in the southeastern Indian state of Tamil Nadu. Preliminary clinical and preclinical data support the potential for Siddha medicine to modulate host immune responses and/or to directly impact HIV kinetics. Some benefit was seen in a small study of a Siddha intervention among individuals with documented HIV disease. The project will aid in capacity building to develop a phase I clinical study. The project is anticipated to result in a five-year program development to prepare for future clinical studies to evaluate efficacy and the cost-effectiveness of this rich and ancient tradition.
