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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 A5146是一项开放式标签，随机的，多中心试验，评估了治疗性药物监测（TDM）对蛋白酶抑制剂（PI）经验的受试者对挽救方案的病毒学反应的影响，这些受试者至少具有低归一化抑制剂（NIQ）的PIS对其所见的PIS的影响。 方案。失败的第二，第三或第四组抗逆转录病毒方案的受试者将使用虚拟表型进行筛查测试，而他们仍保持在失败方案上。 进入时，所有受试者都将进入步骤1，其中使用该阻力测试的结果将由受试者的临床医生选择打捞方案。所有受试者将在第2周在新方案上获得的PI槽水平获得定时的等离子体样本，并将在第4周之前接收其NIQ的结果，以确定随机分为步骤2的资格。步骤2由3个臂组成：CARTANT：TDM标准，TDM，Plus Carever of Careed，Plus标准标准和观察A1手臂。 主要目的是比较TDM+SOC和SOC随机臂之间的等离子体HIV-RNA的平均变化到第24周的平均变化，并将等离子体HN-1 RNA的平均变化从挽救疗法启动（第0周）到第24周的平均变化。