CLINICAL TRIAL: ACTG A5164:IMMEDIATE VS DELAYED ART FOR HIV-INFECTED PATIENTS WI

临床试验：ACTG A5164：针对威斯康星州 HIV 感染患者的立即治疗与延迟治疗

• 批准号: 7718406
• 负责人: JUDITH Ann ABERG
• 金额: $ 2.23万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718406
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Acute; Antiretroviral resistance; Cessation of life; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consensus; Development; Disease; Drug Kinetics; Endopeptidases; Funding; Grant; HIV; HIV-1; Immune; Infection; Inflammatory; Institution; Lead; Lopinavir/Ritonavir; Measures; Opportunistic Infections; Outcome; Peptide Hydrolases; Pharmaceutical Preparations; Plasma; Pneumonia; Quality of life; Randomized; Recovery; Recruitment Activity; Research; Research Personnel; Resources; Safety; Source; Stavudine; Syndrome; Testing; Time; United States National Institutes of Health; Week; antiretroviral therapy; base; clinically significant; reconstitution

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.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是ACTG的一项试验，旨在测量立即与延迟开始抗逆转录病毒治疗（ART）的影响。 基于蛋白酶的ART与免疫重建炎症综合征相关。 关于这种综合症，我们还不太清楚。 也不清楚在艾滋病定义的机会性感染（OI）后免疫重建的时间应该是什么。 这项研究假设，在急性OI治疗过程中启动ART将导致更快地从疾病中恢复。 主要目的是比较立即ART治疗与延迟ART治疗的患者在以下方面的结局：a）无AIDS进展和血浆HIV水平检测不到的生存期; B）无AIDS进展和HIV-1检测不到的生存期;以及c）AIDS进展和死亡。 次要目的是观察CD 4的变化、安全性、生活质量、OI的临床结局以及各组中ARV耐药性的发展。 这是一项为期48周的研究，共有282名患有可治疗的艾滋病定义感染或肺炎的受试者。他们被随机分为立即治疗组（ART在2周内开始）或延迟治疗组（ART在OI治疗开始后不早于4周且不晚于32周开始）。ART将由Kaletra、司他夫定和1或2种其他药物组成。一项子研究将观察OI期间和之后Kaletra的药代动力学。 由于对如何用ART治疗急性OI没有共识，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。 暂时没有结果。