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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5146是一种开放标签、随机、多中心试验。A5146的目标是确定修改剂量的蛋白酶抑制剂(PI)是否改善了PI经验受试者的病毒学反应。在体外，耐PI的HIV需要比PI敏感的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步骤1研究进入时开始的受试者挽救方案中每个PI的归一化抑制商(NIQ)来计算。