PACTG 1020-A: PROTEASE INHIBITOR (BMS 232632) IN COMBINATION REGIMEN IN ART

PACTG 1020-A：艺术中的组合疗法中的蛋白酶抑制剂 (BMS 232632)

• 批准号: 7604242
• 负责人: Ram Yogev
• 金额: $ 0.81万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604242
• 关键词: PACTG; 1020; PROTEASE; INHIBITOR; BMS

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 Version 5.0 is a collaborative study of U.S.A. sites and the PACTG Site in Soweto, South Africa. PACTG 1020-A is designed to provide pharmacokinetic data to guide dosing recommendations for BMS-232632 (ATV, atazanavir, Reyataz) in infants, children, and adolescents. PACTG 1020-A is the first step on establishing the appropriate dosing for this new protease inhibitor in the pediatric population. BMS-232632 is a novel protease inhibitor (PI), with pharmacokinetic parameters that support once daily dosing, a low pill burden for patients, and convenient powder formulation for younger children. The once daily dosing is a distinct advantage for BMS-232632 in the global fight against HIV infection. Easier to follow antiretroviral regimens may improve adherence in resource-poor settings. This PI is also an attractive agent to bring into the field based on its acceptable safety profile and its lack of effect on cholesterol and triglyceride levels, as evidence in adult studies conducted by BMS. The protocol team believes that it is of high importance, for establishing the right dosing for this PI, to develop preliminary data in other countries (besides the United States of America), where people are infected with non-clade B HIV virus. The PACTG 1020-A Team is aware of the ethical and clinical importance of guaranteeing antiretroviral treatment beyond the data collection phase of the study for South African children participating in the study. Therefore, South African patients will remain on study until BMS-232632 is approved in South Africa and it is available by prescription off-study. At this timepoint, patients will go off-study; however, BMS and the PACTG Soweto Site will continue providing the same antiretroviral treatment (i.e. BMS-232632, ritonavir, and two NRTIs) for as long as they are responding virologically. Additionally, BMS will establish a program with the PACTG Soweto Site to supply alternative antiretroviral treatment if BMS-232632 needs to be discontinued due to virologic failure, toxicity findings, and/or tolerability issues. The sponsor of this study is the U.S.A. Division of AIDS (DAIDS) which holds the IND for this study. Study patients in South Africa will be consented and treated as per South African guidelines. The trial will follow Section 9.0 of The Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants, the principles of the Declaration of Helsinki, (October 2000) and the International Conference of Harmonized Tripartite Guidelines for Good Clinical Practice, (May 1997).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 PACTG 1020-A版本5.0是对美国索韦托（Soweto）的美国网站和帕克遗址的协作研究。 PACTG 1020-A旨在提供药代动力学数据，以指导婴儿，儿童和青少年的BMS-232632（ATV，Atazanavir，Reyataz）的给药建议。 PACTG 1020-A是在小儿种群中为这种新的蛋白酶抑制剂建立适当剂量的第一步。 BMS-232632是一种新型的蛋白酶抑制剂（PI），其药代动力学参数每天支撑一次，患者的药丸负担较低，并为年幼儿童提供方便的粉末配方。 在全球抗击艾滋病毒感染中，曾经每天的给药是BMS-232632的独特优势。 更容易遵循抗逆转录病毒方案可以提高资源贫乏的依从性。 该PI也是一种有吸引力的药物，可以根据其可接受的安全性以及对胆固醇和甘油三酸酯水平的影响不足，作为BMS进行的成人研究的证据。 该协议团队认为，在其他国家（除了美利坚合众国除外）开发初步数据的正确剂量是很重要的，在那里人们会感染非果皮B艾滋病病毒。 PACTG 1020-A团队意识到，除了参与研究的南非儿童的数据收集阶段，保证抗逆转录病毒治疗的道德和临床重要性。 因此，在南非批准BMS-232632之前，南非患者将继续进行研究，并且可以通过处方非研究处方。 此时，患者将脱离研究；但是，只要它们在病毒学上做出反应，BMS和PACTG SOWETO部位将继续提供相同的抗逆转录病毒治疗（即BMS-232632，Ritonavir和两个NRTI）。 此外，如果BMS-232632由于病毒衰竭，毒性发现和/或耐受性问题而需要停止，则BMS将建立一个具有PACTG SOWETO部位的程序，以提供替代性抗逆转录病毒治疗。 这项研究的赞助商是美国艾滋病（DAIDS）的美国，该部门拥有本研究的IND。 根据南非准则，将同意南非的研究患者并对待。 该试验将遵循《良好实践指南》第9.0节，在人类参与者中进行临床试验，赫尔辛基宣言的原则（2000年10月）和良好临床实践的统一三角指南（1997年5月）。