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 1020-A是一项在ART初治和经验丰富的患者中进行的BMS-232632（阿扎那韦）和BMS-232632+利托那韦联合治疗的I/II期、国家和国际、多中心、开放标签研究。 年龄为91天至21岁的儿童和青少年（152例受试者）将入组本研究。 主要终点是确定BMS-232632和BMS-232632+利托那韦胶囊和粉末制剂联合两种NRTI在HIV感染儿童和青少年中的药代动力学特征和最佳给药方案。 PACTG 1020-A旨在确定BMS-232632和BMS-232632+利托那韦的四个分层的适当剂量，根据年龄和BMS-232632制剂以及招募国家（美国）定义。S.或南非）。 在研究期间，将密切监测BMS-232632的安全性和耐受性，并获得初步的病毒学疗效数据。 在AI424 - 040 BMS研究中观察到的剂量依赖性QTc和PR延长需要在PACTG 1020 A中继续进行ECG监测。 更广泛的临床经验将允许评估这些发现的临床意义。 粉末制剂的可用性和每日一次给药方案使BMS-232632成为纳入儿科治疗方案的有吸引力的药物。 需要详细的药代动力学数据，因为对于某些蛋白酶抑制剂，幼儿的肝脏清除率约为成人的2倍。