International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): START

全球艾滋病毒试验战略倡议国际网络 (INSIGHT)：启动

• 批准号: 9129596
• 负责人: James Dennis Neaton
• 金额: $ 2941.8万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-19 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9129596
• 关键词: Adherence; Agreement; Anti-Retroviral Agents; Award; Benchmarking; Biological; CD4 Lymphocyte Count; Cells; Clinical Trials; Country; Data; Data Analyses; Databases; Ensure; Event; Funding; HIV; HIV Seropositivity; Health; Health system; Individual; International; International Network for Strategic Initiatives in Global HIV Trials; Journals; Manuscripts; Medical; Morbidity - disease rate; Paper; Participant; Pharmaceutical Preparations; Pharmacologic Substance; Pregnancy; Protocols documentation; Publications; Randomized; Reporting; Research Personnel; Serious Adverse Event; Shipping; Ships; Source; Specific qualifier value; Specimen; Subgroup; Symptoms; Time; Uncertainty; Writing; abstracting; antiretroviral therapy; arm; authority; clinical research site; follow-up; meetings; mortality; randomized trial; repository; response; symposium; treatment strategy; treatment trial; trial design

 DESCRIPTION (provided by applicant): There is uncertainty concerning the optimal time to begin antiretroviral therapy (ART) for asymptomatic HIV-positive individuals with CD4+ cell count > 500 cells/mm3. 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). With this proposal, investigators in the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) will complete follow-up of 4,685 HIV-positive participants already randomized in the START trial; databases will be finalized following study completion; biological specimens will be centrally stored; participants on ART will be transitioned to local sources from the central drug repository; and 10 papers will be prepared for submission to major medical journals. One of these papers will summarize the primary results of the trial and be submitted for publication immediately following study closure. Findings of START will also be presented at scientific conferences.

 描述（由申请方提供）：对于CD 4+细胞计数> 500个细胞/mm 3的无症状HIV阳性个体，开始抗逆转录病毒治疗（ART）的最佳时间尚不确定。抗逆转录病毒治疗的战略时机（START）是一项国际随机试验，旨在确定在CD 4+计数> 500个细胞/mm 3时开始ART（立即或早期ART）在发病率和死亡率方面是否上级延迟ART，直到CD 4+下降到350个细胞/mm 3（延迟ART）。根据这项提议，全球艾滋病毒试验战略倡议国际网络（INSIGHT）的研究人员 将完成对START试验中已随机分配的4，685名HIV阳性受试者的随访;数据库将在研究完成后完成;生物标本将集中储存;接受ART的受试者将从中央药物库转移到当地来源; 并准备向主要医学期刊提交10篇论文。其中一篇论文将总结试验的主要结果，并在研究结束后立即提交发表。裁武会谈的结果也将在科学会议上提出。