Collaborative HIV/AIDS Development Project India

描述（由申请人提供）：西奈山医学院（MSSM）、综合艾滋病研究基金会（FIAR，一个美国非营利组织）和位于泰米尔纳德邦Kilavayal的非政府组织Gandeepam之间的合作项目。正在开发南印度，以便从Siddha传统中确定可能减缓艾滋病毒疾病进展或有助于控制机会性感染的潜在治疗方法。当前项目的目标包括：1)加强联系，并制定评估MSSM、FIAR和Gandeepam之间专业工作关系的方法；2)确定目前综合评价Siddha管理艾滋病毒疾病干预措施的能力；3)提供临床试验设计和实施、irb、患者同意等临床设计相关方面的专业知识、知识共享、培训和见解；4)确保诊断、安全和治疗评估所需的足够基础设施；5)建立一个案例系列，并从Siddha的角度对目前管理艾滋病毒疾病的方法进行初步的第一阶段评估；6)到项目结束时，一个为期五年的申请，制定一个长期的研究议程，并在团队成员之间达成共识的情况下，制定II/ i期临床研究计划，以评估干预效果；7)根据美国和印度的法律和公平贸易原则，探索和发展知识产权和/或其他商业发展问题。

DESCRIPTION (provided by applicant): 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.