AACTG-A5177

AACTG-A5177

• 批准号: 7378871
• 负责人: JOSEPH A EUSTACE
• 金额: $ 0.26万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378871
• 关键词: AACTG; A5177

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. Goals/Methods: A5177 is a multi-center, observational study of the disposition of anti retroviral agents in subjects requiring maintenance hemodialysis. Subjects will be assigned to one of three study arms, on the basis of whether their current antiretroviral regimen includes one and only one of the following: efavirenz (EFV) arm A, nevirapine (NVP) arm B, and lopinavir/ritonavir (LPV/r) Arm C. Subjects compliance with medication for the 3 days prior to study visit will be assessed. At study entry, subjects will be admitted to the General Clinical Research Center (GCRC) approximately 1 hour prior to the time of the observed administration of the study drug. Arm A will require 26 hours of pharmacokinetic (PK) sampling over a single non-hemodialysis day. Arm B will require 14 hours of PK sampling on 2 days, a non-hemodialysis day and a hemodialysis day, to assess hemodialysis clearance of NVP. Arm C will require 12 hours of PK sampling over a single non-hemodialysis day. Drug levels will be measured with a high performance liquid chromatography assay developed to determine the levels of EFV, NVP, or LPV/r in plasma. PK parameters will be compared to historical controls. The study will recruit 46 HIV-infected subjects, aged 18-65 years, with ESRD requiring hemodialysis, and who have been on a stable on stable anti retroviral regimen for at least 30 days. It is planned to enroll 10 subjects at the Johns Hopkins Site, (4 in arm A, 3 Arm B, 3 Arm C). No drugs will be provided by A5177. Subjects will continue taking their usual antiretroviral therapy during the observation period and will be dialyzed (arm B only) as part of their usual clinical management.

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。目的/方法：A5177是一项多中心的观察性研究，旨在观察需要维持性血液透析的受试者中抗逆转录病毒药物的处置情况。受试者将被分配到三个研究小组中的一个，这取决于他们目前的抗逆转录病毒方案是否包括以下之一：EFV(EFV)小组A、奈韦拉平(NVP)小组B和Lopinavir/ritonavir(LPV/r)小组C。将评估受试者在研究访问前3天的药物依从性。在研究进入时，受试者将在观察到的研究药物给药时间的大约1小时前进入综合临床研究中心(GCRC)。ARM A需要在一天的非血液透析中进行26小时的药代动力学(PK)采样。B组需要两天14小时的PK采样，包括非血液透析日和血液透析日，以评估血液透析对NVP的清除。ARM C需要在一天的非血液透析中进行12小时的PK采样。药物浓度将通过开发的用于确定血浆中EFV、NVP或LPV/r水平的高效液相色谱分析来测量。将主键参数与历史控件进行比较。这项研究将招募46名艾滋病毒感染者，年龄在18-65岁之间，患有终末期肾病需要血液透析，并且已经稳定地接受了稳定的抗逆转录病毒治疗至少30天。计划在约翰·霍普金斯大学招收10名受试者(A组4人，B组3人，C组3人)。A5177不会提供任何药物。在观察期间，受试者将继续接受他们通常的抗逆转录病毒治疗，并将进行透析(仅限于B组)，作为他们通常临床治疗的一部分。