ACTG A5146: THERAPEUTIC DRUG MONITORING IN SUBJECTS WITH A LOW NIQ TO PIS (AIDS)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项开放、随机、多中心的研究，旨在评估治疗药物监测(TDM)对补救方案中至少一种蛋白酶抑制剂(PI)归一化抑制商(NIQ)较低的受试者抢救方案的HIV病毒学应答的影响。治疗失败的患者将开始接受新的抗逆转录病毒治疗方案，并在4周后重新测试。如果NIQ等于或小于1，那么他们将被随机分成3组：标准护理(SOC)、SOC+TDM和观察组。他们将被跟踪48周。主要目标是在24周时评估艾滋病毒病毒载量。这是一项关于如何优化治疗失败患者的管理的临床相关的重要研究。这项研究已经启动，并正在进行中。

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 is an open-label, randomized, multicenter study to evaluate the impact of therapeutic drug monitoring (TDM) on HIV virologic response to salvage regimens in protease-inhibitor-experienced subjects who have a low normalized inhibitory quotient (NIQ) to at least one of the protease inhibitors (PI) in their salvage regimen. Patients failing therapy will be started on a new antiretroviral therapy regimen and retested at 4 weeks. If the NIQ is equal to or less than 1, then they will be randomized into one of 3 arms: standard of care (SOC), SOC plus TDM, and observational. They will be followed for 48 weeks. The primary objective is to assess HIV viral load at 24 weeks. This is a clinically relevant, important study on how to optimize management of patients who failed therapy. This study has been initiated on the GCRC and is ongoing.