ACTG A5146

ACTG A5146

• 批准号: 7603193
• 负责人: Michael S. Saag
• 金额: $ 0.18万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603193
• 关键词: AIDS clinical trial group; Anti-Retroviral Agents; Caring; Computer Retrieval of Information on Scientific Projects Database; Drug Monitoring; Eligibility Determination; Funding; Grant; Institution; Label; Multicenter Trials; Phenotype; Plasma; Protease Inhibitor; RNA; Randomized; Research; Research Personnel; Resistance; Resources; Salvage Therapy; Sampling; Screening procedure; Source; Standards of Weights and Measures; Testing; Therapeutic; Time; Treatment Protocols; United States National Institutes of Health; Upper arm; Week; experience; response; virtual

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 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 before week 4, in order to determine eligibility for randomization into Step 2. Step 2 consists of 3 arms: standard of care, TDM plus standard of care, and an Observation a1 arm. The primary objective is to compare the mean change in plasma HIV-RNA from Step 2 entry (week 4) to week 24 between the TDM+SOC and SOC randomized arms and to characterize the mean change in plasma HN-1 RNA from salvage therapy initiation (week 0) to week 24.

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）治疗受试者对挽救治疗方案病毒学应答的影响，这些受试者在挽救治疗中对至少一种PIS的标准化抑制商（NIQ）较低 方案.第二、第三或第四种联合抗逆转录病毒治疗方案失败的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性试验。 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周时获得新方案的PI谷水平的定时血浆样本，并将在第4周前收到其NIQ结果，以确定是否有资格随机分配至第2步。第2步包括3个组：标准治疗组、TDM+标准治疗组和观察a1组。 主要目的是比较TDM+SOC和SOC随机化组之间从第2步入组（第4周）至第24周血浆HIV-RNA的平均变化，并描述从挽救治疗开始（第0周）至第24周血浆HN-1 RNA的平均变化。