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)、 免疫调节疗法以及预防和治疗 HIV 和 ART 并发症的干预措施 - 有序 在人口、社会经济和地理多样化的地区延长无病生存期 感染艾滋病毒的人群。具体研究重点是“临床优化” 管理，包括合并症”，其特点是 1) 大型随机试验 发病率和死亡率结果，并在适当的情况下进行先锋研究以完善设计 参数; 2）与资源丰富国家和资源贫乏国家相关的研究； 3) 研究对象 最大限度地减少长期治疗的不利影响，同时最大限度地提高益处； 4）研究强调 共同注册，以便可以在以下队列中解决多个主要研究问题： 向上; 5) 作为较大试验一部分的机制子研究； 6) 精心策划的流行病学分析， 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 个国家的约 400 个地点进行 5 到 6 次大型试验，在 具有成本效益的方法，强调重要原则〜随机化，临床相关干预措施， 出色的长期随访和集中裁决的临床结果。通过精心研发 分配国际和本地数据质量保证责任的组织计划，高 将收集高质量数据集来解决重要的临床管理问题。凭借经验丰富的 研究人员、与其他网络的合作以及专业领域顾问的指导， 将为科学文献和医疗实践指南做出实质性和及时的贡献。 这些贡献将推进 DAIDS 的使命，即促进治疗进展——发现和治疗艾滋病 HIV感染及其并发症的治疗方法的开发。 INSIGHT Leadership 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)、以及 3) 统计和数据管理中心 (SDMC)。全部 三个组成部分将位于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。

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

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