INTENSIVE PHARMACOKINETIC STUDIES OF ANTIRETROVIRAL DRUG COMBINATIONS HIV

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。 P1058 2.0版是一项密集的24小时PK研究，研究选定的抗逆转录病毒药物在艾滋病毒感染儿童或18岁儿童中的药代动力学，这些儿童正在接受或即将开始包括感兴趣的药物或药物组合之一的抗逆转录病毒药物方案。 目标分为三组。1)通过对年龄较大的儿童和青少年口服替诺福韦联合核苷逆转录酶抑制剂(NRTI)和非核苷逆转录酶抑制剂(NNRTI)的PK抽样来评估稳态。2)在年龄较大的儿童和青少年中，通过对口服辅助性治疗的PK抽样来评估稳态，例如加强的蛋白水解酶抑制剂(PI)，如达鲁那韦/利托那韦与替诺福韦联合使用。3)描述受试者S体表面积与替诺福韦稳态固定剂量治疗期间的体表面积与替诺福韦暴露的关系。

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. P1058 Version 2.0 is an intensive 24-hour pK study of the pharmacokinetics of selected antiretroviral drugs in HIV-infected children > or <18 years of age who are receiving or about to initiate a regimen of antiretrovirals that includes one of the drugs or drug combinations of interest. The objectives are divided into three groups. 1) Assess the steady state by pK sampling of orally administered tenofovir given in combination with nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) to older children and adolescents. 2) Assess the steady state by pK sampling of orally administered concomitant therapies such as boosted protease inhibitors (PI) such as darunavir/ritonavir used with tenofovir in older children and adolescents. 3) Describe the relationship between a subject?s body surface area (BSA) and tenofovir exposure during treatment with a fixed dosage at steady state with or without concomitant PI treatment.