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.

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。 这是首次对新的HIV蛋白酶抑制剂atazanavir进行儿科试验。这项研究将测试不同的剂量，胶囊与粉末制剂，并与和没有加强药物，利托那韦。所有受试者均为3个月至21岁的HIV感染儿童，将接受新药和2种其他HIV药物。这项研究将确定这种新药在儿童中的剂量、安全性和有效性。