ACTG A5223

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。A5223是一项对78名hiv -1感染受试者的前瞻性评估，旨在确定男性和女性LPV的PK。这将是首次在hiv -1感染者中进行的LPV/RTV PK性别差异的大型前瞻性研究。将对78名可评估受试者（39名男性和39名女性）在给予洛匹那韦/利托那韦（LPV/RTV）早晨剂量之前和之后12小时内获得的血浆样本进行药代动力学（PK）评估，这些受试者目前使用LPV/RTV作为抗逆转录病毒治疗方案的一部分。筛选访问将在PK访问前30天内进行。在确认合格后，受试者将返回进行注册/入组访问以参加研究，并将获得48小时用药日记。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小时进行密集的PK血液采样。78名hiv感染者，男39名，女39名，年龄bb0 - 18岁，目前正在接受LPV/RTV（洛匹那韦400mg /利托那韦100mg / bid）加一种或多种以下药物：核苷类逆转录酶抑制剂（nrti）、替诺福韦（核苷酸RTI）和恩福韦肽（融合抑制剂）。受试者必须在筛查前至少14天使用相同的方案。受试者按种族/民族分层。受试者将接受LPV/RTV和以下一种或多种治疗：NRTIs、替诺福韦（TDF）和恩福韦肽（ENF）。本研究不提供这些药物。

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.