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: 7376827
• 负责人: Ram Yogev
• 金额: $ 0.97万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376827
• 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).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。PACTG 1020-A 5.0版是美国研究中心和南非索韦托PACTG研究中心的合作研究。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BMS-232632（ATV、阿扎那韦、Reyataz）的给药建议。PACTG 1020-A是确定这种新型蛋白酶抑制剂在儿科人群中的适当剂量的第一步。 BMS-232632是一种新型蛋白酶抑制剂（PI），其药代动力学参数支持每日一次给药，患者的药丸负担较低，并且适合年幼儿童的方便粉末制剂。每日一次给药是BMS-232632在全球抗击艾滋病毒感染方面的明显优势。在资源匮乏的环境中，更好地遵循抗逆转录病毒疗法可能会提高依从性。该PI也是一种有吸引力的药物，基于其可接受的安全性特征和对胆固醇和甘油三酯水平无影响，BMS进行的成人研究中的证据。 方案团队认为，对于确定该PI的正确剂量，开发其他国家（除美利坚合众国外）的初步数据非常重要，这些国家的人群感染了非进化枝B HIV病毒。 PACTG 1020-A团队意识到在研究的数据收集阶段之后，为参与研究的南非儿童提供抗逆转录病毒治疗的伦理和临床重要性。因此，南非患者将继续参加研究，直至BMS-232632在南非获得批准，并且可通过研究外处方获得。在该时间点，患者将退出研究;但是，只要患者在病毒学上有应答，BMS和PACTG Soweto研究中心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，BMS将与PACTG Soweto研究中心建立一个项目，以便在因病毒学失败、毒性结果和/或耐受性问题需要停用BMS-232632时提供替代抗逆转录病毒治疗。 本研究的申办者是持有本研究IND的美国艾滋病部（DAIDS）。南非的研究患者将获得知情同意，并按照南非指南进行治疗。本试验将遵循人类受试者临床试验实施良好规范指南第9.0节、赫尔辛基宣言原则（2000年10月）和国际协调会议三方药物临床试验质量管理规范指南（1997年5月）。