CLINICAL TRIAL: IMPAACT 1071

临床试验：IMPAACT 1071

• 批准号: 8166872
• 负责人: STEPHEN A SPECTOR
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166872
• 关键词: Adolescent; Child; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Funding; Grant; IMPAACT; Institution; Protease Inhibitor; Regimen; Research; Research Personnel; Resources; Ritonavir; Safety; Source; Staging; United States National Institutes of Health; dosage; experience

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. In Stage I, to evaluate the short term safety and tolerability of vicriviroc in combination with optimized background therapy which includes a ritonavir-boosted protease inhibitor regimen in HIV-infected, treatment experienced children and adolescents. In Stage I, to determine the multi-dose pharmacokinetics of vicriviroc in combination with optimized background therapy which includes a ritonavir-boosted protease inhibitor, and to determine the dose of vicriviroc that achieves a target Cmin in children and adolescents. In Stage II, to evaluate the long term safety and tolerability of the optimized dosage of vicriviroc in combination with optimized background therapy which includes a ritonavir-boosted protease inhibitor in HIV-infected, treatment experienced children and adolescents.

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。 在第一阶段，评估在优化的背景疗法(包括利托那韦增强的蛋白水解酶抑制疗法)联合使用于艾滋病毒感染、有治疗经验的儿童和青少年的短期安全性和耐受性。 在第一阶段，结合优化的背景疗法(包括利托那韦增强的蛋白水解酶抑制剂)，确定多剂量的维立韦罗的药代动力学，并确定在儿童和青少年中达到目标Cmin的维利韦罗的剂量。 在第二阶段，评估优化剂量的维昔洛克与优化的背景疗法相结合的长期安全性和耐受性，优化的背景疗法包括一种利托那韦增强的蛋白酶抑制剂，用于治疗有经验的儿童和青少年。