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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，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）药物与继续使用标准剂量的PI药物在降低病毒载量（血液中HIV的数量）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），其中包括测量PI的血液水平。本研究还将观察是否使用NIQ（归一化抑制商），一种使用TDM调节血液中抗HIV药物水平的新方法，比不使用NIQ和TDM药物水平更好地帮助控制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结果选择和处方。所有受试者必须在研究开始时开始一个包含方案规定剂量的PI的挽救方案。本方案不提供抗逆转录病毒药物。A5146将在基线和在第24周或之后确认HIV-1 RNA为1000拷贝/mL的受试者进行耐药性测试。

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.