International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

全球艾滋病毒试验战略倡议国际网络 (INSIGHT)

• 批准号: 7583335
• 负责人: James Dennis Neaton
• 金额: $ 407.85万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-01-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7583335
• 关键词: Address; Adverse effects; Adverse event; Area; Biometry; CD4 Lymphocyte Count; Clinical; Clinical Management; Collaborations; Country; Data; Data Quality; Data Set; Databases; Disease-Free Survival; Drug Exposure; Enrollment; Exposure to; Failure; HIV; HIV Infections; Immunologics; In Vitro; Incidence; Individual; International; Intervention; Laboratories; Leadership; Literature; Medical; Minnesota; Mission; Morbidity - disease rate; Mutation; Nested Case-Control Study; Operations Research; Outcome; Patients; Pharmaceutical Preparations; Population Heterogeneity; Practice Guidelines; Productivity; Public Health Schools; Randomized; Randomized Controlled Clinical Trials; Research; Research Personnel; Resistance; Resources; Risk; Ritonavir; Site; Specimen; Testing; Therapeutic Intervention; Time; Treatment Protocols; Universities; Viral Load result; Week; adjudicate; antiretroviral therapy; clinically relevant; clinically significant; cohort; cost; data management; design; experience; follow-up; insight; mortality; novel; prevent; quality assurance; repository; therapy development

INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART), immunomodulatory therapies, and interventions to prevent andtreat complications of HIVand ART- inorder to prolong disease-free survival in a demographically, socio-economically, and geographically diverse population of individuals infected with HIV. The specific research emphasis will be "optimization of clinical management, including co-morbidities," and will be characterized by 1) Large randomized trials with morbidity and mortality outcomes, and where appropriate preceded by vanguard studies to refine design parameters; 2) Studies relevant to both resource-rich and resource-poor countries; 3) Studies directed at minimizing the adverse effects of long-term treatment while maximizing the benefits; 4) Studies emphasizing co-enrollment so that more than one major research question can be addressed in the cohorts under follow- up; 5) Mechanistic substudies as part of larger trials; 6) Carefully planned epidemiological analyses, including nested case-control studies that take advantage of a large cross-study database and associated specimen repository; and 7) Linkages with other networks to maximize efficiency and research productivity. INSIGHT will conduct 5 or 6 large trials at approximately 400 sites in 35 countries, implementing the plan in a cost-effective way with emphasis on important principles ~ randomization, clinically relevant interventions, excellent long-term follow-up, and centrally adjudicated clinical outcomes. Through a carefully developed organizational plan that distributes responsibilities for international and local data quality assurance, high- quality data sets will be assembled to address important clinical management questions. With experienced investigators, collaborations with other networks, and the guidance of consultants in specialized areas, substantial and timely contributions will be made to the scientific literature and medical practice guidelines. These contributions will advance the DAIDS mission to promote progress in treatment - the discovery and development of therapies for HIV infection and its complications. The INSIGHT Leadership application includes three components: 1) Coordinating and Research Operations Center (CORE), 2) Network Laboratory (NL), and 3) Statistical and Data Management Center (SDMC). All three components will be colocated at the Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, at the University of Minnesota.

INSIGHT的使命是制定优化治疗策略--抗逆转录病毒疗法（ART）， 免疫调节疗法和干预措施，以预防和治疗艾滋病毒和ART的并发症， 在人口统计学、社会经济学和地理多样性的环境中延长无病生存期， 艾滋病毒感染者的人数。具体的研究重点将是“临床优化 管理，包括合并症，”并将通过1）大型随机试验， 发病率和死亡率结局，并在适当情况下，在此之前进行先锋研究，以完善设计 2）与资源丰富和资源贫乏国家有关的研究; 3）针对 最大限度地减少长期治疗的副作用，同时最大限度地提高效益; 4）研究强调 共同招募，以便在以下队列中解决一个以上的主要研究问题- 5）作为大型试验一部分的机制子研究; 6）精心计划的流行病学分析， 包括利用大型交叉研究数据库和相关的嵌套病例对照研究。 标本库; 7）与其他网络的联系，以最大限度地提高效率和研究生产力。 INSIGHT将在35个国家的大约400个地点进行5或6项大型试验，以一种 强调重要原则的成本效益方法-随机化，临床相关干预， 良好的长期随访和集中裁定的临床结局。通过精心设计的 组织计划，分配国际和本地数据质量保证的责任， 将收集高质量的数据集，以解决重要的临床管理问题。与经验丰富 调查员、与其他网络的合作以及专门领域顾问的指导， 将对科学文献和医疗实践指南作出大量和及时的贡献。 这些贡献将推动DAIDS的使命，以促进治疗的进展-发现和 开发艾滋病毒感染及其并发症的治疗方法。 INSIGHT领导力应用程序包括三个组成部分：1）协调和研究运营 中心（CORE），2）网络实验室（NL）和3）统计和数据管理中心（SDMC）。所有 三个组成部分将在生物识别研究协调中心， 明尼苏达大学公共卫生学院生物统计学。