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。 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（血液中的HIV含量）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），其涉及测量PI的血液水平。 这项研究还将观察使用NIQ（归一化抑制商），一种使用TDM来调节血液中抗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检测结果选择和处方。所有受试者必须在研究入组时启动挽救治疗方案，其中包含方案规定剂量的PI。本方案不提供抗逆转录病毒药物。A5146将在基线时以及第24周或之后确认HIV-1 RNA ≥ 1000拷贝/mL的受试者进行耐药性检测。

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.