A5211 STUDY OF THE SAFETY AND EFFICACY OF SHC417690 IN HIV-INFECTED SUBJECTS

A5211 SHC417690 在 HIV 感染者中的安全性和有效性研究

• 批准号: 7605208
• 负责人: ANDREW RICHARD ZOLOPA
• 金额: $ 12.32万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605208
• 关键词: Adverse effects; Aftercare; Atazanavir; Clinical; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Failure; Funding; Future; Genotype; Grant; Guidelines; HIV-1; Institution; Label; Maintenance; Maintenance Therapy; Measurement; Monitor; Nucleosides; Plasma; Protease Inhibitor; Purpose; RNA; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Risk; Ritonavir; Safety; Source; Time; Treatment Protocols; United States National Institutes of Health; Viral Load result; Week; antiretroviral therapy; base; day; experience; follow-up; non-nucleoside reverse transcriptase inhibitors; pilot trial; prospective

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. A5211 is a prospective, open-label, multicenter, 30-week pilot trial (with follow-up continuing to 54 weeks) in HIV-1-infected subjects with virologic suppression for at least 48 weeks on their first protease inhibitor (PI)-based regimen (defined as at least 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus at least 1 PI). Prior use of nonnucleoside reverse transcriptase inhibitors is not allowed. At entry, subjects switch from their current PI(s) to ritonavir-boosted atazanavir (ATV/RTV) for 6 weeks to monitor for adverse effects (Step 1). Subjects whose current PIs include ATV are eligible and will enter the study at Step 1. Subjects with a plasma HIV-1 RNA 50 copies/mL at week 3 and those who experience treatment-limiting adverse effects during the 6-week lead-in are discontinued from the study and are replaced. Otherwise, subjects discontinue their NRTIs at week 6 and remain on a maintenance regimen of ATV/RTV alone for the duration of the study Step 2. The primary purpose of this study is to evaluate the risk of virologic failure in subjects 24 weeks after treatment with ATV/RTV maintenance therapy alone. Virologic failure is defined as 2 consecutive plasma HIV-1 RNA measurements ?200 copies/mL. Subjects with HIV-1 RNA measurements 200 copies/mL must return within 30 days for confirmation of virologic failure, at which point real-time genotyping will be performed if the second viral load is 1000 copies/mL. Decisions about future antiretroviral therapy will be made according to current clinical guidelines and may include resumption of previous combination therapy. All subjects who permanently discontinue study treatment on Step 2, including those who change therapy due to virologic failure, will be followed off treatment/on study.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5211是一项前瞻性、开放标签、多中心、为期30周的试点试验(随访持续到54周)，在HIV-1感染者中，病毒抑制至少48周，他们的第一个基于蛋白酶抑制剂(PI)的方案(定义为至少2种核苷逆转录酶抑制剂[NRTI]+至少1种PI)。不允许事先使用非核苷类逆转录酶抑制剂。 在进入试验时，受试者从目前的PI(S)切换到利托那韦强化的阿扎那韦(ATV/RTV)，为期6周，以监测不良反应(步骤1)。目前PIs包括ATV的受试者符合条件，将在第一步进入研究。在第三周血浆HIV-1 RNA为50拷贝/毫升的受试者以及在6周引入期间经历限制治疗的不良反应的受试者将停止研究并被取代。否则，受试者在第6周停止他们的NRTI，并在研究步骤2的持续时间内继续只接受ATV/RTV的维持方案。 这项研究的主要目的是评估单独接受ATV/RTV维持治疗24周后受试者病毒学失败的风险。病毒学失败被定义为连续两次血浆HIV-1RNA检测-200拷贝/毫升。HIV-1RNA检测结果为200拷贝/毫升的受试者必须在30天内返回确认病毒学失败，届时如果第二个病毒载量为1000拷贝/毫升，将进行实时基因分型。关于未来抗逆转录病毒治疗的决定将根据目前的临床指导方针做出，并可能包括恢复以前的联合治疗。所有在步骤2中永久停止研究治疗的受试者，包括那些因病毒学失败而改变治疗的受试者，将被跟踪停止治疗/继续研究。