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: 7604380
• 负责人: THOMAS A CAMPBELL
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604380
• 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.

该副本是使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，这是调查员的机构。 这项研究将比较增加蛋白抑制剂（PI）药物增加剂量的有效性和安全性，以继续降低病毒载量（血液中的HIV量），以继续PIS的标准剂量。 PI药物的剂量增加将基于治疗药物监测（TDM），涉及测量PI的血液水平。这项研究还将查看使用NIQ（归一化抑制配额），这是一种使用TDM调整血液中抗HIV药物水平的新方法，有助于控制HIV感染比不使用NIQ和TDM药物水平更好地控制HIV感染。 抗逆转录病毒方案将由受试者的临床选择并根据抗性测试的结果进行规定。所有受试者都必须在研究条目中启动一项抢救方案，该方案包含以方案指定剂量的PI。该方案不会提供抗逆转录病毒药物。 A5146将在基线时提供电阻测试，并为已确认HIV-1 RNA的受试者在第24周或24周之后提供1000份/ml。