SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG HIV-1-INFECTED

HIV-1 感染者洛匹那韦/利托那韦药代动力学的性别差异

• 批准号: 7606446
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 0.19万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606446
• 关键词: Age-Years; Blood specimen; Computer Retrieval of Information on Scientific Projects Database; Drug Kinetics; Eligibility Determination; Enrollment; Evaluation; Funding; Grant; Hour; Institution; Lopinavir; Lopinavir/Ritonavir; Nucleosides; Nucleotides; Pharmaceutical Preparations; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Ritonavir; Screening procedure; Sex Characteristics; Source; T-20; Tenofovir; Treatment Protocols; United States National Institutes of Health; Visit; Woman; day; design; diaries; inhibitor/antagonist; men; prospective

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 (39 men and 39 women) HIV-1-infected subjects designed to determine the pharmacokinetics (PK) of lopinavir (LPV) in men and women ?18 years of age. Subjects must be currently receiving 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. The 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 to be given a 48-hour medication diary. Subjects will be required to spend approximately 13 hours in the GCRC for the intensive PK blood sampling.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 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。 A5223是对78例（39例男性和39例女性）HIV-1感染受试者进行的前瞻性评价，旨在确定洛匹那韦（LPV）在男性和女性中的药代动力学（PK）？18岁 受试者目前必须接受洛匹那韦400 mg/利托那韦100 mg po bid+以下一种或多种药物：核苷逆转录酶抑制剂（NRTI）、替诺福韦（一种核苷酸RTI）和恩夫韦肽（一种融合抑制剂）。受试者必须在筛选前接受相同的方案至少14天。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，并获得48小时药物日记。要求受试者在GCRC中花费约13小时进行密集PK血样采集。