Collaborative HIV/AIDS Development Project India

描述（由申请人提供）：西奈山医学院（MSSM），艾滋病综合研究基金会（FIAR，一家总部位于美国的非营利组织）和位于泰米尔纳德邦Kilavayal的非政府组织Gandeepam之间的合作。印度南部正在开发，以确定Siddha传统中可能减缓艾滋病毒疾病进展或有助于管理机会性感染的潜在治疗方法。目前项目的目标包括：1）加强联系，并制定方法，以评估MSSM、FIAR和Gandeepam之间的专业工作关系; 2）确定目前全面评估Siddha管理艾滋病毒疾病干预措施的能力; 3）提供专业知识、知识共享、培训和对临床试验设计和实施的见解，IRB，患者同意和临床设计的其他相关方面; 4）确保诊断、安全性和治疗评价的适当基础设施需求; 5）建立病例系列和从Siddha角度对当前管理HIV疾病的方法进行初步I期评价; 6）在项目结束时，五年的应用开发长期研究议程沿着，随着团队成员之间达成共识，计划进行II/III期临床研究以评估干预效果; 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。 该合作将支持能力建设工作，这将维持西奈山和FIAR在临床试验和社区/基础设施发展方面的专业知识与Gandeepam项目之间的联系，该项目为农村非常贫困的人口提供服务。它是一个植根于古印度传统医学体系的非政府组织，该体系被称为Siddha，起源于印度东南部的泰米尔纳德邦。初步的临床和临床前数据支持Siddha药物调节宿主免疫反应和/或直接影响HIV动力学的潜力。在一项关于Siddha干预有记录的艾滋病患者的小型研究中看到了一些好处。该项目将有助于能力建设，以开展I期临床研究。该项目预计将导致一个为期五年的项目开发，为未来的临床研究做准备，以评估这一丰富而古老的传统的功效和成本效益。

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.