INTENSIVE PHARMACOKINETIC STUDIES OF ANTIRETROVIRAL DRUG COMBINATIONS

抗逆转录病毒药物组合的深入药代动力学研究

• 批准号: 7952269
• 负责人: MARGARET A KELLER
• 金额: $ 1.82万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952269
• 关键词: 18 year old; Adolescent; Anti-Retroviral Agents; Body Surface Area; Child; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Drug Combinations; Drug Kinetics; Funding; Grant; Hour; Institution; Nucleosides; Pharmaceutical Preparations; Protease Inhibitor; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Ritonavir; Sampling; Source; Tenofovir; Treatment Protocols; United States National Institutes of Health; dosage; interest; non-nucleoside reverse transcriptase inhibitors

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 P1058 2.0 版是一项针对正在接受或即将开始包含感兴趣的药物或药物组合的抗逆转录病毒治疗方案的 HIV 感染儿童或 18 岁儿童中选定的抗逆转录病毒药物的药代动力学的 24 小时 pK 强化研究。 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与核苷逆转录酶抑制剂 (NRTI) 和非核苷逆转录酶抑制剂 (NNRTI) 联合给药的 pK 采样来评估稳态。 2) 通过口服伴随疗法的 pK 采样来评估稳态，例如在年龄较大的儿童和青少年中与替诺福韦一起使用的增强型蛋白酶抑制剂 (PI)，如达芦那韦/利托那韦。 3) 描述受试者的体表面积 (BSA) 与稳定状态下固定剂量的替诺福韦暴露量之间的关系，无论是否同时进行 PI 治疗。