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

基本信息

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
项目类别：
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

项目摘要

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.

项目概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是否在 CD4+ 计数 > 500 个细胞/mm3 时开始 ART（立即或早期 ART）在发病率和死亡率方面优于推迟 ART 直至 CD4+ 下降至 350 个细胞/mm3（延迟 ART）。经过平均3年的时间后，2015年5月15日后续，START的独立数据和安全监控委员会（DSMB）确定研究的主要问题已经得到解答。平均随访 3 年，就主要终点而言，立即使用 ART 比延迟 ART 具有显着优势 START（艾滋病毒和非艾滋病事件的综合）（比率为每 100 人 0.60 和 1.38）立即和延期 ART 组的人年。 DSMB 建议结果立即传播，为延迟 ART 组的参与者提供机会 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 中登记的 4,684 名艾滋病毒阳性参与者到 2021 年 12 月，并进行最终数据分析，以确定是否一旦接受抗逆转录病毒疗法，与延迟开始相关的主要发病率和死亡率的风险就会被消除是否启动且 HIV RNA 水平受到抑制或是否持续存在。之前没有随机试验已经解答了这个问题。多篇论文将总结长期随访结果结果还将在科学会议上公布。