PHARMACOKINETIC AMP; SAFETY STUDY OF PROTEASE INHIBITOR IN COMB IN HIV INFECTED

药代动力学放大器；

• 批准号: 7379450
• 负责人: ANN J MELVIN
• 金额: $ 0.92万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379450
• 关键词: PHARMACOKINETIC; AMP; SAFETY; STUDY; PROTEASE

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. This is a Phase I/II multi-center investigation being conducted at PACTG sites throughout the US and at the PACTG site in Soweto, South Africa. PACTG 1020-A is designed to provide pharmacokinetic (PK) data to guide dosing recommendations for BMS-232632 (ATV, atazanavir, Reyataz+) in infants, children, and adolescents. This means that the study will look specifically at how the body absorbs, distributes, metabolizes and excretes the drug. PACTG 1020-A is the first step in establishing the appropriate dosing for this new protease inhibitor in the pediatric population. BMS-232632 is a novel protease inhibitor (PI), licensed for use in adults that can be given once a day. 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. The other advantage of this PI is its lack of effect on cholesterol and triglyceride levels. This study has been on-going since 2000. Part A included subjects given BMS-232632 without a ritonavir boost. This part of the study is closed and only groups 7 and 8 of Part B remain open for accrual. Only the subjects in South Africa will participate in step II of the study, so this application will not address step II.

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。列出的机构适用于该中心，这不一定是调查员的机构。这是在美国和南非索韦托的PACTG地点和南非的PACTG地点进行的I/II期多中心研究。 PACTG 1020-A旨在提供药代动力学（PK）数据，以指导婴儿，儿童和青少年的BMS-232632（ATV，Atazanavir，Reyataz+）的剂量建议。这意味着该研究将专门研究身体如何吸收，分散，代谢和排泄该药物。 PACTG 1020-A是在小儿种群中为这种新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），可在成人中使用，每天可以使用一次。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依从性。该PI的另一个优点是它缺乏对胆固醇和甘油三酸酯水平的影响。自2000年以来，这项研究就一直在进行中。A部分A部分为BMS-232632，而没有利托纳维尔提升。该研究的这一部分是关闭的，仅B部分的第7组和第8组仍保持开放额。只有南非的受试者才能参加研究的第二步，因此该申请不会解决第二步。