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

 描述(由申请人提供)：对于CD4细胞计数为500个/mm~3的无症状艾滋病毒阳性患者，何时开始抗逆转录病毒治疗(ART)存在不确定性。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CD4计数为500个/mm3(立即或早期ART)时开始ART在发病率和死亡率方面是否优于推迟ART，直到CD4降至350个/mm3(延迟ART)。有了这项建议，全球艾滋病毒试验战略倡议国际网络(Insight)的研究人员 将完成对在START试验中已经随机抽取的4,685名艾滋病毒阳性参与者的后续行动；数据库将在研究完成后最后确定；生物标本将被集中存储；参加抗逆转录病毒治疗的参与者将从中央药物储存库过渡到当地来源； 并将准备10篇论文提交给主要的医学期刊。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出版。《削减战略武器条约》的研究结果也将在科学会议上公布。

 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.