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: 9917949
• 负责人: James Dennis Neaton
• 金额: $ 17.96万
• 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: 2019-01-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9917949
• 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（Start）的战略时机是国际随机试验 旨在确定在CD4+计数上是否启动ART> 500个单元/mm3（立即 或早期艺术在发病率和死亡率方面比延期递减直到CD4+更高 下降至350个单元/mm3（递延艺术）。平均3年后，2015年5月15日 随访，独立数据和安全监控委员会（DSMB）开始确定 研究的主要问题已经回答。平均随访3年， 立即使用艺术品为主要终点的递延艺术提供了巨大的好处 （艾滋病和非辅助事件的综合）开始（速率为0.60和1.38 直接和递延艺术团体的人数。 DSMB建议 结果立即传播，提供递延艺术小组的参与者 艺术，并认识到相对较短的随访，随访继续。有了这个建议， 全球艾滋病毒试验中国际战略计划的研究人员 （Insight）将继续对入学的4,684名HIV阳性参与者进行跟进 到2021年12月，并进行最终数据分析旨在确定是否是否 一旦艺术，就消除了与延迟开始相关的主要发病率和死亡率的风险 启动并抑制HIV RNA水平或是否持续。没有事先随机试验 已经解决了这个问题。多篇论文将总结长期的后续发现 结果也将在科学会议上提出。