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的使命是开发优化治疗的策略--抗逆转录病毒疗法(ART)， 预防和治疗HIV和ART并发症的免疫调节疗法和干预措施 在人口、社会经济和地理多样化的地区延长无病生存期 感染艾滋病毒的个人人口。具体的研究重点将是“临床优化”。 管理，包括共病“，并将以1)大型随机试验为特征 发病率和死亡率结果，并在适当的情况下在此之前进行先锋研究以改进设计 参数；2)与资源丰富的国家和资源贫乏的国家有关的研究；3)针对 将长期治疗的不良影响降至最低，同时使益处最大化；4)强调 共同登记，以便可以在以下队列中解决一个以上的主要研究问题- UP；5)作为更大试验的一部分的机械学分研究；6)精心规划的流行病学分析， 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；以及7)与其他网络的联系，以最大限度地提高效率和研究生产率。 Insight将在35个国家和地区的大约400个地点进行5到6个大型试验，在 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，并集中判断临床结果。通过精心开发的 组织计划，分配国际和当地数据质量保证的责任，高 将汇集高质量的数据集，以解决重要的临床管理问题。有经验的人 调查人员、与其他网络的合作以及专业领域顾问的指导， 将对科学文献和医疗实践指南作出实质性和及时的贡献。 这些贡献将推动DAIDS任务，以促进治疗方面的进展--发现和 艾滋病毒感染及其并发症的治疗方法的发展。 洞察领导力应用程序包括三个组件：1)协调和研究操作 中心(CORE)，2)网络实验室(NL)，3)统计和数据管理中心(SDMC)。全 三个组成部分将放在生物识别研究协调中心分部 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

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

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

Soluble biomarkers and morbidity and mortality among people infected with HIV: summary of published reports from 1997 to 2010.

感染艾滋病毒的人的可溶性生物标志物以及发病率和死亡率：1997年至2010年发表的报告摘要。

• DOI: 10.1097/coh.0b013e32833ed75d
• 发表时间: 2010-11
• 期刊: Current opinion in HIV and AIDS
• 影响因子: 4.1
• 作者: Neaton JD;Neuhaus J;Emery S
• 通讯作者: Emery S