RALTEGRAVIR PHARMACOKINETICS WITH AND WITHOUT ATAZANAVIR IN HEALTHY ADULTS

健康成人中使用和不使用阿扎那韦的拉替拉韦药代动力学

• 批准号: 7982145
• 负责人: Michael N. Neely
• 金额: $ 35.93万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 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/7982145
• 关键词: Adult; Atazanavir; Blood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Interactions; Drug Kinetics; FDA approved; Funding; Genetic Crossing Over; Grant; HIV; Institution; Patients; Pharmaceutical Preparations; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Upper arm; Urine; clinical efficacy; pharmacokinetic model; volunteer

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. Raltegravir is the most recent FDA-approved HIV medication and must be dosed twice daily. However, a drug interaction with an older HIV agent, Atazanavir, may permit Raltegravir to dosed once daily.The objective of this study is to determine the pharmacokinetics and safety of Raltegravir doesd with Atazanavir in healthy adult volunteers. The study design is a randomized cross-over between one of two arms: Raltegravir dosed at a standard dose twice daily (arm A) or Raltegravir dosed once daily with a standard single daily dose of Atazanavir (arm B). Blood and urine concentrations will be used to model the pharmacokinetics of Raltegravir alone and in combination with Atazanavir. If the average minimum Raltegravir concentration in the once daily arm is at least 40% of the concentration in the standard arm, then the combination will be judged eligible for further clinical efficacy studies in HIV-infected patients.

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。 拉替拉韦是 FDA 最新批准的 HIV 药物，必须每天服用两次。然而，与较老的 HIV 药物 Atazanavir 的药物相互作用可能允许 Raltegravir 每日给药一次。本研究的目的是确定 Raltegravir 与 Atazanavir 联合用药在健康成年志愿者中的药代动力学和安全性。该研究设计是两个组之一之间的随机交叉：Raltegravir以标准剂量每天两次给药（A组）或Raltegravir每天一次与标准单次阿扎那韦剂量一起给药（B组）。血液和尿液浓度将用于模拟拉替拉韦单独使用以及与阿扎那韦联合使用的药代动力学。如果每日一次组中拉替拉韦的平均最低浓度至少是标准组中浓度的 40%，则该组合将被判定有资格在 HIV 感染患者中进行进一步的临床疗效研究。