CLINICAL TRIAL: PHASE I/II, OPEN-LABEL, PHARMACOKINETIC AND SAFETY STUDY OF A NO

临床试验：I/II 期、开放标签、药代动力学和安全性研究

• 批准号: 7982099
• 负责人: MARGARET KHOURY
• 金额: $ 2.65万
• 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/7982099
• 关键词: Adolescent; Anti-Retroviral Agents; Child; Childhood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Formulations; Drug Kinetics; Funding; Grant; Infant; Institution; Multicenter Studies; Phase; Phase I Clinical Trials; Powder dose form; Research; Research Personnel; Resources; Safety; Schedule; Source; Treatment Protocols; United States National Institutes of Health; capsule; open label; safety study

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. PACTG P1020-A is a phase I/II, open-label multicenter study of BMS-232632 as part of combination antiretroviral regimens. The availability of a powder formulation and once-daily dosing makes BMS-232632 an attractive agent for inclusion in pediatric regimens. The PACTG P1020-A study will determine the pharmacokinetic profile and dosing schedule of the capsule formulation for BMS-232632 in combination with two NRTIs, determine the pharmacokinetic profile and dosing schedule for the powder formulation in combination with two NRTIs, and determine the safety and tolerability of BMS-232632 in HIV-infected infants, children, and adolescents.

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。 PACTG P1020-A是一项BMS-232632作为联合抗逆转录病毒治疗方案一部分的I/II期、开放标签、多中心研究。 粉末制剂和每日一次给药的可用性使BMS-232632成为儿科治疗方案中有吸引力的药物。 PACTG P1020-A研究将确定BMS-232632胶囊制剂联合两种NRTI的药代动力学特征和给药方案，确定粉末制剂联合两种NRTI的药代动力学特征和给药方案，并确定BMS-232632在HIV感染婴儿、儿童和青少年中的安全性和耐受性。