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: 8119284
• 负责人: James Dennis Neaton
• 金额: $ 136.29万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-16 至 2012-02-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8119284
• 关键词: Address; Adverse effects; Adverse event; Area; Biometry; CD4 Lymphocyte Count; Clinical; Clinical Management; Collaborations; Comorbidity; Country; Data Quality; Data Set; Databases; Disease-Free Survival; Drug Exposure; Enrollment; Epidemiology; Exposure to; Failure; HIV; HIV Infections; Immunologics; In Vitro; Incidence; Individual; Inferior; International; International Network for Strategic Initiatives in Global HIV Trials; Intervention; Laboratories; Leadership; Literature; Medical; Minnesota; Mission; Morbidity - disease rate; Nested Case-Control Study; Operations Research; Outcome; Patients; Persons; Pharmaceutical Preparations; Population Heterogeneity; Practice Guidelines; Productivity; Public Health Schools; Randomized; Regimen; Research; Research Personnel; Resistance; Resources; Risk; Ritonavir; Site; Specimen; Testing; Therapeutic Intervention; Time; Universities; Viral Load result; adjudicate; antiretroviral therapy; arm; clinically relevant; clinically significant; cohort; cost; data management; design; experience; follow-up; high risk; mortality; novel; prevent; quality assurance; randomized trial; repository; resistance mutation; therapy development; treatment strategy

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的策略 - 抗逆转录病毒疗法（ART）， 免疫调节疗法和预防艾滋病毒艺术和治疗并发症的干预措施 在人口统计学，社会经济和地理上多样化中延长无疾病的生存 感染艾滋病毒的个体人群。具体的研究重点将是“临床的优化 管理，包括合并症，“并将以1）大型随机试验为特征 发病率和死亡率结果，并在适当的前先进行先锋研究以完善设计 参数; 2）与资源丰富和资源贫乏国家有关的研究； 3）针对的研究 最大程度地减少长期治疗的不利影响，同时最大程度地提高收益； 4）强调的研究 共同注册，以便在以下组中可以解决多个主要的研究问题 - 向上; 5）机械替代品作为较大试验的一部分； 6）精心计划的流行病学分析， 包括利用大型跨研究数据库和相关的嵌套病例对照研究 标本存储库； 7）与其他网络的联系，以最大程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次大型试验，并在A中实施该计划 具有成本效益的方式，重点是重要原则〜随机化，临床相关的干预措施， 出色的长期随访和中央裁定的临床结果。通过精心发展的 为国际和地方数据质量保证分配责任的组织计划，高 质量数据集将组装以解决重要的临床管理问题。经验丰富 调查人员，与其他网络的合作以及在专业领域的顾问的指导， 将对科学文献和医学实践指南做出大量和及时的贡献。 这些贡献将推进daids的使命，以促进治疗进展 - 发现和 开发艾滋病毒感染及其并发症的疗法。 洞察力领导申请包括三个组成部分：1）协调和研究操作 中心（核心），2）网络实验室（NL）和3）统计和数据管理中心（SDMC）。全部 将在生物识别研究中心的协调中心进行三个组成部分， 明尼苏达大学公共卫生学院生物统计学。

项目成果

Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study.

• DOI: 10.1177/1740774512440342
• 发表时间: 2013
• 期刊: Clinical trials (London, England)
• 作者: Babiker AG;Emery S;Fätkenheuer G;Gordin FM;Grund B;Lundgren JD;Neaton JD;Pett SL;Phillips A;Touloumi G;Vjechaj MJ;INSIGHT START Study Group
• 通讯作者: INSIGHT START Study Group

Will expanded ART use reduce the burden of HIV-associated chronic lung disease?

扩大抗逆转录病毒疗法的使用会减轻艾滋病毒相关慢性肺病的负担吗？

• DOI: 10.1097/coh.0000000000000018
• 发表时间: 2014
• 期刊: Current opinion in HIV and AIDS
• 影响因子: 4.1
• 作者: Kunisaki,KenM

Improved virological and immunological efficacy of resistance-guided switch in antiretroviral therapy: a Frankfurt HIV cohort analysis.

• DOI: 10.1007/s00430-014-0350-5
• 发表时间: 2014-12
• 期刊: Medical microbiology and immunology
• 影响因子: 5.4
• 作者: Wolf T;Fuß B;Khaykin P;Berger A;Knecht G;Gute P;Brodt HR;Goepel S;Bickel M;Stuermer M;Stephan C;Frankfurt HIV Cohort Study
• 通讯作者: Frankfurt HIV Cohort Study

Comparison of the Outcomes of Individuals With Medically Attended Influenza A and B Virus Infections Enrolled in 2 International Cohort Studies Over a 6-Year Period: 2009-2015.

• DOI: 10.1093/ofid/ofx212
• 发表时间: 2017
• 期刊: Open forum infectious diseases
• 影响因子: 4.2
• 作者: Dwyer DE;Lynfield R;Losso MH;Davey RT;Cozzi-Lepri A;Wentworth D;Uyeki TM;Gordin F;Angus B;Qvist T;Emery S;Lundgren J;Neaton JD;INSIGHT Influenza Study Group
• 通讯作者: INSIGHT Influenza Study Group

Considerations for Endpoint Selection When Designing HIV Clinical Trials.

设计 HIV 临床试验时终点选择的注意事项。

• DOI: 10.1007/s11908-011-0231-7
• 发表时间: 2012
• 期刊: Current infectious disease reports
• 影响因子: 3.1
• 作者: Hullsiek,KatherineHuppler;Grund,Birgit
• 通讯作者: Grund,Birgit