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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 雷特格韦是FDA批准的最新的艾滋病药物，必须每天服用两次。然而，药物相互作用与一个老的艾滋病毒代理，阿扎那韦，可能允许雷特格韦dosedoneday.The本研究的目的是确定的药物动力学和安全性雷特格韦does与阿扎那韦在健康成人志愿者。研究设计是两组之一的随机交叉：雷特格韦标准剂量每日两次给药（A组）或雷特格韦每日一次给药与阿扎那韦标准每日一次给药（B组）。血液和尿液浓度将用于模拟雷特格韦单药和与阿扎那韦联合给药的药代动力学。如果每日一次组的平均最小雷特格韦浓度至少为标准组浓度的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。