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).

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。 PACTG 1020-A版本5.0是对美国站点和位于南非索韦托的PACTG站点的合作研究。PACTG1020-A旨在提供药代动力学数据，以指导婴儿、儿童和青少年使用BMS-232632(阿托伐他韦、阿扎那韦、雷亚塔兹)的剂量建议。PACTG 1020-A是在儿科人群中建立这种新的蛋白酶抑制剂的适当剂量的第一步。 BMS-232632是一种新型的蛋白酶抑制剂(PI)，其药代动力学参数支持每天一次给药，患者的服药负担较低，并且为幼儿提供了方便的粉剂配方。每天一次的剂量是BMS-232632在全球抗击艾滋病毒感染方面的一个明显优势。在资源匮乏的情况下，更容易遵循抗逆转录病毒方案可能会提高依从性。这种PI也是一种有吸引力的药物，因为它的安全性可以接受，而且它对胆固醇和甘油三酯水平没有影响，这是BMS进行的成人研究的证据。 方案小组认为，在感染非B类HIV病毒的其他国家(除美利坚合众国外)开发初步数据，对于确定这种PI的正确剂量非常重要。 PACTG 1020-A小组意识到在研究的数据收集阶段之后对参与研究的南非儿童保证抗逆转录病毒治疗的伦理和临床重要性。因此，南非患者将继续接受研究，直到BMS-232632在南非获得批准，并可通过非研究处方获得。此时，患者将离开研究；然而，只要病毒学上有反应，BMS和PACTG Soweto网站将继续提供相同的抗逆转录病毒治疗(即BMS-232632、利托那韦和两种NRTI)。此外，百时美施贵宝将与PACTG索韦托分部建立一个项目，如果由于病毒学故障、毒性发现和/或耐受性问题而需要停止使用百美施贵宝-232632，该公司将提供替代的抗逆转录病毒治疗。 这项研究的赞助商是美国艾滋病部门(DAIDS)，它持有这项研究的IND。在南非进行研究的患者将得到同意，并按照南非的指导方针进行治疗。该试验将遵循《人体临床试验良好实践指南》第9.0节、《赫尔辛基宣言》的原则(2000年10月)和国际良好临床实践协调三方指南会议(1997年5月)。