A5146 A RANDOMIZED-CONTROLLED TRIAL EVALUATING THE IMPACT OF TDM

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是一项开放标签、随机、多中心试验，评估治疗药物监测(TDM)对回收方案中至少一种PI归一化抑制商(NIQ)*较低的受试者抢救方案的病毒学反应的影响。HIV未能通过第二、第三或第四联合抗逆转录病毒方案的受试者，将在继续接受失败方案的同时，使用虚拟表型进行筛查耐药性测试。在参赛时，所有受试者将进入步骤1，在该步骤中，受试者的临床医生将使用该耐药性测试的结果来选择抢救方案。所有受试者将在第二周获得新方案中PI谷值的定时血浆样本，并将收到他们的NIQ结果(臂C中为1或1)。

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 evaluating the impact of therapeutic drug monitoring (TDM) on virologic response to a salvage regimen in protease inhibitor (PI)-experienced subjects who have a low normalized inhibitory quotient (NIQ)* to at least one of the PIs in their salvage regimen. Subjects with HIV failing their second, third, or fourth combination antiretroviral regimen will have a screening resistance test performed using a virtual phenotype while they remain on their failing regimen. At entry, all subjects will enter Step 1, in which a salvage regimen will be selected by the subject's clinician using results of this resistance test. All subjects will have timed plasma samples obtained for PI trough levels on the new regimen at week 2, and will receive results of their NIQ (1 or 1 in Arm C).