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.

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 中心，不一定是研究者的机构。 PACTG 1020-A 是一项 I/II 期、国内和国际、多中心、开放标签研究，针对 BMS-232632（阿扎那韦）和 BMS-232632 + 含利托那韦的联合疗法，适用于未接受过 ART 的患者和有过 ART 经验的患者。 91 天至 21 岁的儿童和青少年（152 名受试者）将被纳入该研究。 主要终点是确定 BMS-232632 和 BMS-232632 + 利托那韦与两种 NRTI 组合的胶囊和粉末制剂在 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 旨在确定四个层次的 BMS-232632 和 BMS-232632 + 利托那韦的适当剂量，根据年龄和 BMS-232632 配方以及注册国家/地区（美国或南非）进行定义。 研究期间，将密切监测BMS-232632的安全性和耐受性，并获得初步病毒学疗效数据。 AI424-040 BMS 研究中观察到的剂量依赖性 QTc 和 PR 延长需要在 PACTG 1020A 中继续进行心电图监测。 更大的临床经验将有助于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方案使 BMS-232632 成为儿科治疗方案中有吸引力的药物。 需要详细的药代动力学数据，因为幼儿对某些蛋白酶抑制剂的肝脏清除率大约是成人的 2 倍。