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.
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