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

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来源获得了主要资金，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。这是一项I/II期多中心研究，正在美国各地的PACTG研究中心和南非索韦托的PACTG研究中心进行。 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BMS-232632（ATV、阿扎那韦、Reyataz+）的给药建议。这意味着该研究将专门研究身体如何吸收，分配，代谢和排泄药物。PACTG 1020-A是在儿科人群中建立这种新型蛋白酶抑制剂适当剂量的第一步。BMS-232632是一种新型蛋白酶抑制剂（PI），已获准用于成人，每日一次。每日一次给药是BMS-232632在全球抗击HIV感染中的明显优势。更严格地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部分包括给予BMS-232632而未给予利托那韦加强的受试者。研究的这一部分已关闭，仅B部分的第7组和第8组仍开放招募。仅南非的受试者将参与研究的第II步，因此本申请将不涉及第II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 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.