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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项来自ACTG的试验，以衡量立即开始抗逆转录病毒治疗(ART)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。关于这种综合征，人们几乎不清楚。也不清楚在定义艾滋病的机会性感染(OI)后，免疫重建的时机应该是什么。这项研究假设，在急性OI的治疗过程中启动ART将导致更快地从疾病中恢复。主要目标是比较即刻与延迟性抗逆转录病毒治疗的结果，涉及a)没有艾滋病进展和无法检测到血浆艾滋病毒水平的生存；b)没有艾滋病进展和可检测到艾滋病毒-1的生存；以及c)艾滋病进展和死亡。次要目标着眼于这些组的CD4、安全性、生活质量、OI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，涉及282名患有可治疗的艾滋病感染或肺炎的受试者。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)或延期治疗组(开始抗逆转录病毒治疗不早于4周，不晚于开始治疗OI后32周)。抗逆转录病毒药物将包括卡来特拉、司他夫定和1到2种额外的药物。另一项子研究将观察卡莱特拉在OI期间和之后的药代动力学。由于对于如何用ART治疗急性OI患者没有达成共识，因此测试立即治疗与延迟治疗(12周)的问题具有临床意义。继续为这项研究招募受试者。目前还没有结果。

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.