LOPINAVIR PHARMACOKINETICS IN MEN AND WOMEN (HIV)

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 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 研究中心，而研究中心不一定是研究者所在的机构。 成人艾滋病临床试验组方案A5223是一项多中心、前瞻性研究，旨在评价洛匹那韦/利托那韦（Kaletra，LPV/RTV）在女性和男性中的药代动力学（PK）。LPV是一种用于治疗HIV感染的蛋白酶抑制剂（PI），与低剂量RTV（一种用于增强LPV全身暴露的PI）共同配制。将入组接受LPV/RTV治疗至少14天（作为HIV治疗方案的一部分）的HIV感染者。在观察到口服LPV/RTV（400 mg/100 mg）给药前即刻和给药后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例受试者在全国范围内入组（其中约8例在当地入组）。

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).