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（由适用提供）：对于开始抗逆转录病毒疗法（ART）的最佳时间存在不确定性，对于CD4+细胞计数> 500个细胞/mm3的非对称HIV阳性个体。抗逆转录病毒治疗（Start）的战略时机是一项国际随机试验，旨在确定CD4+计数> 500个细胞/mm3（即时或早期艺术）在递延艺术的发病率和死亡率方面是否优越，直到CD4+ CD4+下降到350个细胞/MM3（延迟艺术）。通过这项建议，全球艾滋病毒试验国际战略倡议网络的研究人员（Insight） 将完成在开始试验中已经随机进行的4,685名HIV阳性参与者的随访；研究完成后，数据库将最终确定；生物标本将被集中存储；艺术的参与者将从中央药物存储库过渡到当地来源； 并准备10篇论文，以提交主要的医学期刊。这些论文之一将总结试验的主要结果，并在研究结束后立即提交出版。开始的发现也将在科学会议上提出。