PHASE I/II, OPEN LABEL, PHARMACOKINETIC AND SAFETY STUDY OF A NOVEL PROTEASE

新型蛋白酶的 I/II 期、开放标签、药代动力学和安全性研究

• 批准号: 7608133
• 负责人: DOUGLAS WATSON
• 金额: $ 0.42万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608133
• 关键词: Age-Years; Atazanavir; Child; Childhood; Computer Retrieval of Information on Scientific Projects Database; Drug Formulations; Drug Kinetics; Effectiveness; Endopeptidases; Funding; Grant; HIV; HIV Protease Inhibitors; Institution; Label; Peptide Hydrolases; Pharmaceutical Preparations; Phase; Powder dose form; Research; Research Personnel; Resources; Ritonavir; Safety; Source; Testing; United States National Institutes of Health; capsule; dosage; novel

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. This is the first pediatric trial of the new HIV protease inhibitor, atazanavir. The study will test different dosages, capsule versus powder formulation, and with and without the boosting drug, ritonavir. All subjects are children 3 months to 21 years of age who are infected with HIV and will receive the new drug with 2 other HIV drugs. The study will determine the dosage, safety, and effectiveness of this new drug in children.

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。 这是新型艾滋病毒蛋白酶抑制剂阿扎那韦的首次儿科试验。该研究将测试不同的剂量、胶囊与粉末制剂，以及是否含有增强药物利托那韦。所有受试者都是 3 个月至 21 岁的感染 HIV 的儿童，他们将接受新药和其他 2 种 HIV 药物的治疗。该研究将确定这种新药在儿童中的剂量、安全性和有效性。