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.

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。 拉替格列韦是FDA批准的最新HIV药物，每天必须服用两次。然而，与一种较老的HIV药物阿扎那韦的药物相互作用可能允许拉替格列韦每天给药一次。本研究的目的是确定拉替格列韦与阿扎那韦在健康成年志愿者中的药代动力学和安全性。这项研究设计是在两组中的一组之间随机交叉进行的：每天两次标准剂量的雷替格雷(A组)或每天一次的雷替格雷与标准的每天一次的阿扎那韦(B组)。血液和尿液浓度将被用来模拟雷替格列韦单独和与阿扎那韦联合使用的药代动力学。如果每天服用一次的ARM中的平均最低雷替格列韦浓度至少是标准ARM中浓度的40%，那么这种组合将被判断为符合进一步的HIV感染患者临床疗效研究的条件。