ACTG A5146

ACTG A5146

• 批准号: 7603674
• 负责人: Jeffrey Lennox
• 金额: $ 0.04万
• 依托单位: EMORY UNIVERSITY
• 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 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603674
• 关键词: AIDS clinical trial group; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Monitoring; Funding; Goals; Grant; HIV; In Vitro; Institution; Label; Modification; Multicenter Trials; Pharmaceutical Preparations; Protease Inhibitor; Randomized; Research; Research Personnel; Resistance; Resources; Source; Therapeutic Uses; Treatment Protocols; United States National Institutes of Health; experience; improved; response

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. A5146 is an open-label, randomized, multicenter trial. The goal of A5146 is to determine whether dose modification of protease inhibitors (PIs) improves virologic response in PI-experienced subjects. PI-resistant HIV needs higher PI levels to be suppressed than PI-sensitive HIV in vitro. A5146 will use therapeutic drug monitoring (TDM) to optimize PI drug concentrations. Optimal drug levels will be calculated by determining the normalized inhibitory quotient (NIQ) for each PI in the subject's salvage regimen that is initiated at Step 1 study entry.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 A5146 是一项开放标签、随机、多中心试验。 A5146 的目标是确定蛋白酶抑制剂 (PI) 的剂量调整是否可以改善经历过 PI 的受试者的病毒学反应。在体外，PI 耐药性 HIV 需要比 PI 敏感 HIV 更高的 PI 水平才能被抑制。 A5146 将使用治疗药物监测 (TDM) 来优化 PI 药物浓度。最佳药物水平将通过确定在第 1 步研究开始时开始的受试者挽救方案中每个 PI 的标准化抑制商 (NIQ) 来计算。