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

ACTG A5146：NIQ 至 PIS 较低的受试者（艾滋病）的治疗药物监测

• 批准号: 7378281
• 负责人: JUDITH Ann ABERG
• 金额: $ 1.5万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378281
• 关键词: ACTG; A5146; THERAPEUTIC; DRUG; MONITORING

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项开放标签、随机、多中心的研究，旨在评估治疗性药物监测（TDM）对蛋白酶抑制剂治疗方案中至少一种蛋白酶抑制剂（PI）的归一化抑制商（NIQ）较低的患者HIV病毒学反应的影响。治疗失败的患者将开始新的抗逆转录病毒治疗方案，并在4周后重新进行测试。如果NIQ等于或小于1，那么他们将被随机分为3组：标准护理组（SOC）、SOC加TDM组和观察组。他们将被随访48周。主要目的是评估24周时的HIV病毒载量。这是一项关于如何优化治疗失败患者管理的重要临床研究。这项关于GCRC的研究已经开始，并正在进行中。