LOPINAVIR PHARMACOKINETICS IN MEN AND WOMEN

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。成人艾滋病临床试验组织方案A5223是一项多中心前瞻性研究，旨在评估洛比那韦/利托那韦(Kaletra，LPV/RTV)在女性和男性体内的药代动力学(PK)。LPV是一种用于治疗HIV感染的蛋白酶抑制剂(PI)，与小剂量RTV共同配制，RTV是一种用于增加LPV全身暴露的PI。服用LPV/RTV至少14天(作为其艾滋病毒治疗方案的一部分)的艾滋病毒感染者将被登记。在观察到的口服LPV/RTV剂量(400 mg/100 mg)之前和之后，分别在给药后1、2、3、4、5、6、8、10和12小时评估LPV和RTV的血药浓度。这些数据将用于推导标准PK参数。将有78个科目在全国范围内招生(其中约8个在当地注册)。

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. Adult AIDS Clinical Trials Group protocol A5223 is a multicenter, prospective study to evaluate the pharmacokinetics (PK) of Lopinavir/Ritonavir (Kaletra , LPV/RTV) in women and men. LPV is a protease inhibitor (PI) used in the treatment of HIV infection and is co-formulated with low dose RTV, a PI used to enhance the systemic exposure of LPV. HIV infected individuals who are taking LPV/RTV for at least 14 days (as part of their HIV treatment regimen) will be enrolled. Blood concentrations of LPV and RTV will be assessed immediately before and then following an observed oral dose of LPV/RTV (400mg/100mg) at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post dose. These data will be used to derive standard PK parameters. There will be 78 subjects enrolled nationally (approximately 8 of these locally).