ACTG A5164:IMMEDIATE VS DELAYED ART FOR HIV-INFECTED PATIENTS WITH ACUTE OT

ACTG A5164：针对 HIV 感染急性 OT 患者的立即治疗与延迟治疗

• 批准号: 7378293
• 负责人: JUDITH Ann ABERG
• 金额: $ 2.67万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378293
• 关键词: ACTG; A5164; IMMEDIATE; VS; DELAYED

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a trial from the ACTG to measure the impact of immediate versus delayed initiation of antiretroviral therapy (ART). Protease-based ART is associated with an immune reconstitution inflammatory syndrome. Little about this syndrome is clear. Nor is it clear what the timing of immune reconstitution should be after an AIDS-defining opportunistic infection (OI). This study hypothesizes that initiating ART during the course of treatment of an acute OI will lead to a more rapid recovery from the disease. The primary objective is to compare the outcomes of those with immediate to those with delayed ART with regard to a) survival without AIDS progression and undetectable plasma HIV levels; b) survival without AIDS progression and detectable HIV-1; and c) AIDS progression and death. The secondary objectives look at changes in CD4, safety, quality of life, clinical outcomes of the OI, and the development of ARV resistance in the groups. This is a 48-week study of 282 subjects presenting with a treatable AIDS-defining infection or pneumonia. They are randomized into an Immediate Treatment Group (with ART starting within 2 weeks) or a Deferred Treatment Group (where ART is initiated no earlier than 4 weeks and no later than 32 weeks after starting treatment for the OI). The ART will consist of Kaletra, stavudine, and 1 or 2 additional drugs. A substudy will look at the pharmacokinetics of Kaletra during and after the OI. As there is no consensus on how to treat those with an acute OI with ART, testing the issue of immediate versus delayed (12 weeks) treatment is of clinical significance. Subjects continue to be recruited for this study. No results are available yet.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是ACTG的一项试验，旨在衡量立即开始抗逆转录病毒治疗与延迟开始抗逆转录病毒治疗（ART）的影响。基于蛋白酶的抗逆转录病毒治疗与免疫重建炎症综合征有关。关于这种综合症，人们知之甚少。在艾滋病定义的机会性感染（OI）后，免疫重建的时机也不清楚。本研究假设在急性成骨不全的治疗过程中开始抗逆转录病毒治疗将导致疾病更快的恢复。主要目的是比较立即接受抗逆转录病毒治疗的患者与延迟接受抗逆转录病毒治疗的患者在以下方面的结局：a)无艾滋病进展的生存期和无法检测到的血浆艾滋病毒水平；b)无艾滋病进展和可检测到HIV-1的生存期；c)艾滋病进展和死亡。次要目标是观察各组中CD4的变化、安全性、生活质量、成骨不全的临床结果以及ARV耐药性的发展。这是一项为期48周的研究，共有282名患者出现了可治疗的艾滋病感染或肺炎。他们被随机分为立即治疗组（在2周内开始抗逆转录病毒治疗）或延迟治疗组（在OI开始治疗后不早于4周和不迟于32周开始抗逆转录病毒治疗）。抗逆转录病毒治疗将包括卡列妥、司他夫定和1或2种其他药物。一项子研究将观察Kaletra在成骨不全期间和之后的药代动力学。由于对于如何用ART治疗急性成骨不全患者尚无共识，因此测试立即与延迟（12周）治疗的问题具有临床意义。本研究继续招募受试者。目前还没有结果。