AACTG-A5177

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。目的/方法：A5177是一项多中心、观察性研究，研究需要维持性血液透析的受试者使用抗逆转录病毒药物的情况。受试者将被分配到三个研究组中的一个，基于他们目前的抗逆转录病毒治疗方案是否包括以下一种或仅一种：依非韦伦（EFV）组A，奈韦拉平（NVP）组B和洛匹那韦/利托那韦（LPV/r）组c。受试者在研究访问前3天的药物依从性将被评估。在研究开始时，受试者将在观察研究药物给药时间前约1小时进入普通临床研究中心（GCRC）。A组将需要在一个非血液透析日进行26小时的药代动力学（PK）采样。B组将在2天（非血液透析日和血液透析日）进行14小时的PK采样，以评估NVP的血液透析清除率。C组将需要在一个非血液透析日进行12小时的PK采样。药物水平将采用高效液相色谱法测定血浆中EFV、NVP或LPV/r的水平。PK参数将与历史对照进行比较。这项研究将招募46名艾滋病毒感染者，年龄在18-65岁之间，患有需要血液透析的ESRD，并且已经接受稳定的抗逆转录病毒治疗至少30天。计划在约翰霍普金斯网站招募10名受试者，（A组4名，B组3名，C组3名）。A5177不提供药物。在观察期间，受试者将继续接受常规的抗逆转录病毒治疗，并将透析（仅B组）作为其常规临床管理的一部分。

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.