LOPINAVIR PHARMACOKINETICS IN MEN AND WOMEN (HIV)

洛匹那韦在男性和女性中的药代动力学（HIV）

• 批准号: 7603478
• 负责人: Ann Cornwall Collier
• 金额: $ 0.1万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603478
• 关键词: AIDS clinical trial group; Adult; Blood; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Drug Kinetics; Enrollment; Funding; Grant; HIV; HIV Infections; Hour; Individual; Institution; Lopinavir; Lopinavir/Ritonavir; Oral; Prospective Studies; Protease Inhibitor; Protocols documentation; Research; Research Personnel; Resources; Ritonavir; Source; Standards of Weights and Measures; Treatment Protocols; United States National Institutes of Health; Woman; day; men

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. Adult AIDS Clinical Trials Group protocol A5223 is a multicenter, prospective study to evaluate the pharmacokinetics (PK) of lopinavir/ritonavir (Kaletra, LPV/RTV) in women and men. LPV is a protease inhibitor (PI) used in the treatment of HIV infection and is co-formulated with low dose RTV, a PI used to enhance the systemic exposure of LPV. HIV infected individuals who are taking LPV/RTV for at least 14 days (as part of their HIV treatment regimen) will be enrolled. Blood concentrations of LPV and RTV will be assessed immediately before and then following an observed oral dose of LPV/RTV (400mg/100mg) at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post dose. These data will be used to derive standard PK parameters. There will be 78 subjects enrolled nationally (approximately 8 of these locally).

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。子项目及 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。 成人艾滋病临床试验组方案 A5223 是一项多中心前瞻性研究，旨在评估洛匹那韦/利托那韦（克力芝、LPV/RTV）在女性和男性中的药代动力学 (PK)。 LPV 是一种用于治疗 HIV 感染的蛋白酶抑制剂 (PI)，与低剂量 RTV 共同配制，RTV 是一种用于增强 LPV 全身暴露的 PI。服用 LPV/RTV 至少 14 天（作为 HIV 治疗方案的一部分）的 HIV 感染者将被纳入。将在观察口服 LPV/RTV (400mg/100mg) 剂量之前和给药后 1、2、3、4、5、6、8、10 和 12 小时立即评估 LPV 和 RTV 的血液浓度。这些数据将用于导出标准 PK 参数。 全国将招收 78 个科目（其中约 8 个为本地科目）。