ACTG A5146

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。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。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。 A5146是一项开放标签、随机、多中心试验。A5146的目的是确定蛋白酶抑制剂（PI）的剂量调整是否改善PI经历受试者的病毒学应答。在体外，PI耐药HIV比PI敏感HIV需要更高的PI水平才能被抑制。A5146将使用治疗药物监测（TDM）优化PI药物浓度。将通过确定受试者进入研究第1步时开始的挽救治疗方案中每个PI的归一化抑制商（NIQ）来计算最佳药物水平。

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. A5146 is an open-label, randomized, multicenter trial. The goal of A5146 is to determine whether dose modification of protease inhibitors (PIs) improves virologic response in PI-experienced subjects. PI-resistant HIV needs higher PI levels to be suppressed than PI-sensitive HIV in vitro. A5146 will use therapeutic drug monitoring (TDM) to optimize PI drug concentrations. Optimal drug levels will be calculated by determining the normalized inhibitory quotient (NIQ) for each PI in the subject's salvage regimen that is initiated at Step 1 study entry.