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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究将比较增加剂量的蛋白酶抑制剂(PI)药物与继续使用标准剂量的PI药物在降低病毒载量(血液中的HIV量)方面的有效性和安全性。PI药物剂量的增加将基于治疗药物监测(TDM)，其中包括测量血液中PI的水平。这项研究还将研究使用NIQ(归一化抑制商)，这是一种使用TDM来调节血液中抗艾滋病毒药物水平的新方法，是否比不使用NIQ和TDM药物水平有助于更好地控制艾滋病毒感染。 受试者的临床医生将根据耐药性测试的结果选择和开出抗逆转录病毒治疗方案。所有受试者必须在研究开始时启动抢救方案，其中包含方案规定剂量的PI。该方案不会提供抗逆转录病毒药物。A5146将提供基线的耐药性测试，以及在第24周或之后确认HIV-1RNA？1000拷贝/毫升的受试者。

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.