ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS

ACTG A5223：洛匹那韦/利托那韦药代动力学的性别差异

• 批准号: 7605753
• 负责人: JUDITH Ann ABERG
• 金额: $ 2.19万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605753
• 关键词: 18 year old; Adverse effects; Anti-Retroviral Agents; Area; Blood specimen; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Eligibility Determination; Enrollment; Ethnic Origin; Evaluable Disease; Evaluation; Funding; Grant; Hour; Institution; Lead; Lopinavir; Lopinavir/Ritonavir; Nucleosides; Nucleotides; Pharmaceutical Preparations; Plasma; Race; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Ritonavir; Sampling; Screening procedure; Sex Characteristics; Source; T-20; Tenofovir; Therapeutic Effect; Time; Treatment Protocols; United States National Institutes of Health; Visit; Woman; day; diaries; inhibitor/antagonist; men

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. This study hypothesizes that women achieve higher lopinavir (LPV) drug levels than do men on similar doses of LPV and ritonavir (RTV). The primary objective is to compare the pharmacokinetic (PK) parameter, area under the concentration-time curve (AUC) of LPV between HIV-1-infected men and women currently receiving similar doses of LPV/RTV. PK evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of 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 the GCRC for the intensive PK blood sampling. Subjects will be > 18 years old and 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 will be stratified by race/ethnicity. This study may lead to increased power and generalizability of findings in men; preliminary studies suggest differences in PK, side effects, and therapeutic effects in women.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究假设女性在类似剂量的LPV和Ritonavir（RTV）上获得比男性更高的lopinavir（LPV）药物水平。 主要目的是比较HIV-1感染的男性和目前接受类似剂量的LPV/RTV的HIV-1感染的男性和女性之间LPV浓度时曲线（AUC）下的药代动力学（PK）参数。 PK评估将对在78名可评估受试者（39名男性和39名女性）的早晨剂量在LPV/RTV上进行的78名可评估受试者（39名男性和39名女性）的早晨剂量之前的血浆样品进行。 筛查将在PK访问前30天内进行。 确认资格后，受试者将返回注册/入门访问以注册研究，并将为48小时的药物日记完成。 受试者将被要求在GCRC上花费大约13个小时进行密集的PK血液采样。 Subjects will be > 18 years old and 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). 受试者必须在筛查前至少14天处于同一方案。 受试者将根据种族/种族进行分层。 这项研究可能导致男性发现的功率和普遍性。初步研究表明，女性PK，副作用和治疗作用的差异。