Extended follow-up of randomized participants in the INSIGHT START trial

对 INSIGHT START 试验中随机参与者的长期随访

• 批准号: 9483459
• 负责人: James Dennis Neaton
• 金额: $ 111.95万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-17 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9483459
• 关键词: Acquired Immunodeficiency Syndrome; Address; Applications Grants; Authorization documentation; Award; Bacterial Infections; CD4 Lymphocyte Count; Calendar; Cardiovascular Diseases; Cells; Characteristics; Cirrhosis; Clinical; Clinical Trials Data Monitoring Committees; Collection; Consent; Data; Data Analyses; Data Collection; End stage renal failure; Enrollment; Event; Foundations; Funding; Future; Geography; Grant; HIV; HIV Seropositivity; International; International AIDS; International Network for Strategic Initiatives in Global HIV Trials; Journals; Longterm Follow-up; Malignant Neoplasms; Medicine; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; New England; Outcome; Paper; Participant; Persons; Protocols documentation; Publishing; RNA; Randomized; Recommendation; Research Personnel; Risk; Societies; Subgroup; Time; Treatment Protocols; Tuberculosis; Viral; Work; antiretroviral therapy; arm; cost efficient; follow-up; meetings; mortality; primary endpoint; randomized trial; response; symposium; trait; treatment group; treatment guidelines; treatment trial; trial design; virus genetics

Project Summary The Strategic Timing of Antiretroviral Treatment (START) is an international randomized trial designed to determine whether initiation of ART at CD4+ counts > 500 cells/mm3 (immediate or early ART) is superior in terms of morbidity and mortality to deferral of ART until the CD4+ declines to 350 cells/mm3 (deferred ART). On May 15, 2015 after an average of 3 years of follow-up, the independent Data and Safety Monitoring Board (DSMB) for START determined that the study primary question had been answered. Over an average follow-up of 3 years, immediate use of ART provided significant benefit over deferred ART for the primary endpoint (a composite of AIDS and non-AIDS events) of START (rates were 0.60 and 1.38 per 100 person years for the immediate and deferred ART groups. The DSMB recommended that results be immediately disseminated, that participants in the deferred ART group be offered ART, and recognizing the relatively short follow-up, that follow-up continue. With this proposal, investigators in the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) will continue follow-up of the 4,684 HIV-positive participants enrolled in START through December 2021, and carry out final data analyses aimed at determining whether the risk of major morbidity and mortality associated with delayed initiation is eliminated once ART is initiated and HIV RNA levels are suppressed or whether it persists. No prior randomized trial has addressed this question. Multiple papers will summarize the long-term follow-up findings and results will also be presented at scientific conferences.

项目摘要 抗逆转录病毒治疗的战略时机(START)是一项国际随机试验 旨在确定启动抗逆转录病毒治疗是否在CD4+计数500个/mm~3(立即 或早期抗逆转录病毒治疗)在发病率和死亡率方面优于推迟至CD4+的抗逆转录病毒治疗 降至350个/mm3(延期抗逆转录病毒治疗)。2015年5月15日，在经历了平均3年的 后续，独立的数据和安全监测委员会(DSMB)确定了START 研究的主要问题已经得到回答。在平均3年的随访中， 对于主端点来说，立即使用ART比推迟使用ART有显著的好处 (艾滋病和非艾滋病事件的综合)START(比率分别为0.60和1.38/100 直接艺术团体和延期艺术团体的个人年数。Dsmb建议 立即公布结果，向推迟的ART小组的参与者提供 ART，并认识到后续行动相对较短，后续行动仍在继续。有了这个提议， 全球艾滋病毒试验战略倡议国际网络的研究人员 (Insight)将继续跟踪START登记的4684名艾滋病毒阳性参与者 到2021年12月，并进行最终数据分析，旨在确定 一旦ART消除了与延迟启动相关的重大发病率和死亡率的风险 艾滋病毒RNA水平被抑制，或者是否持续存在。没有先前的随机试验 已经解决了这个问题。多篇论文将总结长期的随访结果 研究结果也将在科学会议上公布。