A5146 A RANDOMIZED-CONTROLLED TRIAL EVALUATING THE IMPACT OF TDM

这个子项目是许多研究子项目中的一个 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。 A5146是一项开放标签、随机化、多中心试验，旨在评价治疗药物监测（TDM）对蛋白酶抑制剂（PI）治疗受试者挽救治疗方案病毒学应答的影响，这些受试者在挽救治疗方案中对至少一种PI的归一化抑制商（NIQ）* 较低。 第二、第三或第四种联合抗逆转录病毒治疗方案失败的HIV受试者将在继续接受失败的治疗方案时，使用虚拟表型进行筛选耐药试验。 入组时，所有受试者将进入第1步，其中受试者的临床医生将使用该耐药试验的结果选择挽救治疗方案。所有受试者将在第2周获得新方案下PI谷水平的定时血浆样本，并将收到其NIQ结果（C组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).