PACTG 1020A: BMS232632 IN COMB REGIMENS IN ART-NAIVE & EXPERIENCED HIV CHILDREN

PACTG 1020A：BMS232632 在 ART-NAIVE 梳子方案中的应用

• 批准号: 7605063
• 负责人: Elizabeth Jane McFarland
• 金额: $ 2.04万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/7605063
• 关键词: Adolescent; Adult; Age; Arts; Atazanavir; BMS232632; Child; Childhood; Clinical; Comb animal structure; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Country; Daily; Data; Dose; Drug Formulations; Drug Kinetics; Electrocardiogram; End Point; Enrollment; Funding; Grant; HIV; Hepatic; Institution; International; Label; Monitor; Patients; Phase; Powder dose form; Protease Inhibitor; Rate; Research; Research Personnel; Resources; Ritonavir; Safety; Schedule; Source; South Africa; Treatment Protocols; United States National Institutes of Health; capsule; clinically significant; day; design; 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. PACTG 1020-A is a Phase I/II, national and international, multicenter, open-label study of BMS-232632 (atazanavir) and BMS-232632 + ritonavir-containing combination therapies for ART-naive and -experienced patients. Children and adolescents (152 subjects) from the age 91 days to 21 years will be enrolled into the study. The primary endpoint is to determine the pharmacokinetic profile and optimal dosing schedule of the capsule and powder formulations of BMS-232632 and BMS-232632 + ritonavir in combination with two NRTIs in HIV-infected children and adolescents. PACTG 1020-A is designed to determine appropriate doses of BMS-232632 and BMS-232632 + ritonavir for four strata, defined with respect to age and BMS-232632 formulation, and country of enrollment (U. S. or South Africa). During the study, the safety and tolerance of BMS-232632 will be closely monitored, and preliminary virologic efficacy data will be obtained. The observed dose-dependent QTc and PR prolongation found in AI424-040 BMS study warrant continued ECG monitoring in PACTG 1020A. A larger clinical experience will allow an assessment of the clinical significance of these findings. The availability of a powder formulation and the once-daily dosing schedule makes BMS-232632 an attractive agent for inclusion in pediatric treatment regimens. Detailed pharmacokinetic data are needed as young children have had approximately 2-fold higher rate of hepatic clearance versus adults for some protease inhibitors.

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。 PACTG1020-A是一项国内和国际的I/II期、多中心、开放标签的BMS-232632(阿特拉那韦)和BMS-232632+利托那韦联合疗法的研究，适用于初学ART和有经验的患者。年龄从91天到21岁的儿童和青少年(152名受试者)将参加这项研究。主要目的是确定BMS-232632和BMS-232632+利托那韦胶囊和粉剂在感染艾滋病毒的儿童和青少年中与两种NRTI联合使用的药代动力学特征和最佳给药方案。PACTG1020-A旨在根据年龄、BMS-232632配方和登记国家(美国或南非)确定四个层次的适当剂量的BMS-232632和BMS-232632+利托那韦。在研究期间，将密切监测BMS-232632的安全性和耐受性，并将获得初步的病毒学疗效数据。在AI424-040BMS研究中观察到的QTC和PR延长呈剂量依赖性，证明在PACTG 1020A中继续进行心电图监测是必要的。更大的临床经验将使我们能够评估这些发现的临床意义。粉末配方的可用性和每日一次的给药计划使BMS-232632成为儿科治疗方案中具有吸引力的制剂。需要详细的药代动力学数据，因为儿童对某些蛋白水解酶抑制剂的肝脏清除率大约是成人的2倍。