PHARMACOKINETIC & SAFETY STUDY OF PROTEASE INHIBITOR IN COMB IN HIV INFECTED

药代动力学

• 批准号: 7603567
• 负责人: ANN J MELVIN
• 金额: $ 0.2万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603567
• 关键词: Address; Adherence; Adolescent; Adult; Anti-Retroviral Agents; Atazanavir; BMS232632; Child; Childhood; Cholesterol; Comb animal structure; Computer Retrieval of Information on Scientific Projects Database; Daily; Data; Dose; Drug Kinetics; Funding; Grant; HIV Infections; Infant; Institution; Investigation; Licensing; Pharmaceutical Preparations; Phase; Population; Protease Inhibitor; Recommendation; Reporting; Research; Research Personnel; Resources; Ritonavir; Safety; Site; Source; South Africa; Treatment Protocols; Triglycerides; United States National Institutes of Health; day; design; fight against; improved; novel

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 ongoing since 2000. Part A included subjects given BMS-232632 without a ritonavir boost. Only the subjects in South Africa will participate in step II of the study, so this report will not address step II.

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。 这是一项 I/II 期多中心调查，正在美国各地的 PACTG 站点和南非索韦托的 PACTG 站点进行。 PACTG 1020-A 旨在提供药代动力学 (PK) 数据，以指导 BMS-232632（ATV、阿扎那韦、Reyataz+）在婴儿、儿童和青少年中的剂量建议。 这意味着该研究将专门研究人体如何吸收、分布、代谢和排泄药物。 PACTG 1020-A 是确定这种新型蛋白酶抑制剂在儿科人群中适当剂量的第一步。 BMS-232632 是一种新型蛋白酶抑制剂 (PI)，获准用于成人，每天一次。 每日一次给药是 BMS-232632 在全球抗击 HIV 感染方面的明显优势。 更容易遵循的抗逆转录病毒治疗方案可能会提高依从性。 该 PI 的另一个优点是它对胆固醇和甘油三酯水平没有影响。 这项研究自 2000 年以来一直在进行。A 部分包括接受 BMS-232632 治疗但未加强利托那韦的受试者。 只有南非的受试者才会参与研究的第二步，因此本报告不会讨论第二步。