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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项I/II期多中心研究，在美国各地的PACTG基地和南非索韦托的PACTG基地进行。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、儿童和青少年中的给药建议。这意味着该研究将特别关注人体如何吸收、分配、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），已被批准用于成人，每天一次。每日一次给药是BMS-232632在全球抗击艾滋病毒感染中的一个明显优势。更容易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。这项研究从2000年开始进行。A部分包括给予BMS-232632而不加利托那韦的受试者。这部分研究已经结束，只有B部分的第7组和第8组继续开放。只有南非的受试者将参与研究的第二步，因此本申请将不涉及第二步。

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 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.