ACTG A5146:IMPACT OF THERAPEUTIC DRUG MONITORING (TDM) ON VIROLOGIC RESPONSE

ACTG A5146：治疗药物监测 (TDM) 对病毒学反应的影响

• 批准号: 7719430
• 负责人: THOMAS A CAMPBELL
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719430
• 关键词: Anti-HIV Agents; Anti-Retroviral Agents; Blood; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Monitoring; Funding; Grant; HIV; HIV Infections; HIV-1; Institution; Measures; Pharmaceutical Preparations; Protease Inhibitor; Protocols documentation; RNA; Research; Research Personnel; Resistance; Resources; Safety; Source; Specific qualifier value; Standards of Weights and Measures; Testing; Therapeutic; Therapeutic Uses; Treatment Protocols; United States National Institutes of Health; Viral Load result; Week; base; compare effectiveness; response

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 study will compare the effectiveness and safety of using increased doses of protease inhibitor (PI) drugs to continuing standard doses of PIs in lowering viral load (amount of HIV in the blood). The dose increases of the PI drugs will be based upon Therapeutic Drug Monitoring (TDM), which involves measuring blood levels of PIs. This study will also see if using an NIQ (normalized inhibitory quotient), a new way of using TDM to adjust the levels of anti HIV drug in the blood, helps control HIV infection better than not using the NIQ and TDM drug levels. Antiretroviral regimens will be selected and prescribed by the subject's clinician based on the results of the resistance testing. All subjects must initiate a salvage regimen at study entry that contains a PI at protocol-specified doses. Antiretroviral drugs will not be provided by this protocol. A5146 will provide resistance testing at baseline and for subjects who have confirmed HIV-1 RNA ¿ 1000 copies/mL at or after week 24.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究将比较使用增加剂量的蛋白酶抑制剂 (PI) 药物与持续使用标准剂量的 PI 在降低病毒载量（血液中 HIV 数量）方面的有效性和安全性。 PI 药物的剂量增加将基于治疗药物监测 (TDM)，其中涉及测量 PI 的血液水平。 这项研究还将了解使用 NIQ（标准化抑制商）（一种使用 TDM 调整血液中抗 HIV 药物水平的新方法）是否比不使用 NIQ 和 TDM 药物水平更有助于控制 HIV 感染。 抗逆转录病毒治疗方案将由受试者的临床医生根据耐药性测试的结果来选择和处方。所有受试者必须在研究开始时启动挽救方案，其中包含方案指定剂量的 PI。该方案不提供抗逆转录病毒药物。 A5146 将为在第 24 周或之后确认 HIV-1 RNA 1000 拷贝/mL 的受试者提供基线耐药性测试。