ACTG A5223

ACTG A5223

• 批准号: 7378939
• 负责人: Charles W. Flexner
• 金额: $ 0.69万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378939
• 关键词: ACTG; A5223

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。A5223是对78例HIV-1感染受试者进行的前瞻性评价，旨在确定LPV在男性和女性中的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例可评价受试者（39例男性和39例女性）在洛匹那韦/利托那韦（LPV/RTV）早晨给药前和给药后12小时内采集的血浆样本进行药代动力学（PK）评价，这些受试者目前接受LPV/RTV作为抗逆转录病毒治疗方案的一部分。筛选访视将在PK访视前30天内进行。在确认合格性后，受试者将返回进行登记/入组访视以入组研究，并将获得48小时药物日志以完成。受试者将被要求在一般临床研究中心（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感染受试者，39名男性和39名女性，年龄> 18岁，目前接受LPV/RTV（洛匹那韦400 mg/利托那韦100 mg po bid）加以下一种或多种药物：核苷逆转录酶抑制剂（NRTI）、替诺福韦（核苷酸RTI）和恩夫韦肽（融合抑制剂）。受试者必须在筛选前至少14天接受相同的治疗方案。受试者将按人种/种族分层。受试者将接受LPV/RTV和以下一种或多种治疗：NRTI、替诺福韦（TDF）和恩夫韦肽（ENF）。本研究不提供这些药物。