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

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。 这是一项第一阶段/第二阶段多中心调查，正在美国各地的PACTG地点和南非索韦托的PACTG地点进行。PACTG1020-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(阿托伐他韦、阿扎那韦、雷亚塔兹+)的剂量建议。这意味着这项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)，获准在成年人身上使用，每天给药一次。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。更容易遵循抗逆转录病毒疗法可能会提高依从性。这种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部分包括服用BMS-232632而不服用利托那韦的受试者。只有南非的受试者才会参与这项研究的第二步，因此本报告将不涉及第二步。

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.