ACTG A5223

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。A5223是对78名HIV-1感染者的前瞻性评估，旨在确定男性和女性LPV的PK。这将是首次对HIV-1感染者LPV/RTV PK的性别差异进行的大型前瞻性研究。将对78名可评估受试者(39名男性和39名女性)在服用上午剂量的Lopinavir/ritonavir(LPV/RTV)之前和之后12小时内获得的血浆样本进行药代动力学(PK)评估，这是作为其抗逆转录病毒治疗方案的一部分。在PK访问前30天内将进行筛查访问。在确认合格后，受试者将返回注册/进入访问以登记加入研究，并将被给予48小时的药物日记以完成。受试者将被要求在普通临床研究中心(GCRC)或类似的研究诊所环境中花费大约13个小时进行密集的PK血液采集。78名艾滋病毒感染者，39名男性和39名女性，年龄&>18岁，目前正在接受LPV/RTV(洛匹那韦400毫克/利托那韦100毫克，每日2次)加以下一种或多种药物：核苷逆转录酶抑制剂(NRTIs)、替诺福韦(一种核苷酸RTI)和恩福韦德(一种融合抑制剂)。受试者必须在筛查前至少14天接受相同的治疗方案。受试者应按种族/民族分层。受试者将接受LPV/RTV以及以下一种或多种药物的治疗：NRTIs、替诺福韦(TDF)和恩福韦肽(ENF)。这项研究不会提供这些药物。

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. A5223 is a prospective evaluation of 78 HIV-1-infected subjects designed to determine the PK of LPV in men and women. It will be the first large prospective study of sex differences in the PK of LPV/RTV conducted in HIV-1-infected individuals. Pharmacokinetic (PK) evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of lopinavir/ritonavir (LPV/RTV) in 78 evaluable subjects (39 men and 39 women) currently managed on LPV/RTV as part of their antiretroviral regimen. A screening visit will occur within 30 days prior to the PK visit. Upon confirmation of eligibility, subjects will return for a registration/entry visit to enroll into the study and will be given a 48 hour medication diary to complete. Subjects will be required to spend approximately 13 hours at a general clinical research center (GCRC) or a similar research clinic setting for the intensive PK blood sampling.Seventy-eight HIV-infected subjects, 39 men and 39 women, age > 18 years currently receiving LPV/RTV (lopinavir 400 mg/ritonavir 100 mg po bid) plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide RTI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening.Subjects to be stratified by race/ethnicity. Subjects will be on LPV/RTV and one or more of the following: NRTIs, tenofovir (TDF), and enfuvirtide (ENF). These drugs will not be provided by this study.