IMPACT OF THERAPEUTIC DRUG MONITORING ON VIROLOGIC RESPONSE TO A SALVAGE REGIMEN

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。 这项研究的目的是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药物在降低病毒载量方面的有效性。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归一化抑制商(NIQ)是否有助于更好地控制HIV感染，是否比不使用NIQ和TDM药物水平更好，并研究基于TDM增加PI药物剂量的安全性。受试者必须至少有两种抗艾滋病毒药物组合，其中包括一种未能控制艾滋病毒感染的PI。大约860名受试者将登记进入第一步，这将涉及到选择抢救方案。在这些研究中，450名受试者预计将进入步骤2，随机分为三个研究分支之一：标准护理、TDM护理标准或观察。受试者的参与预计将持续48周。主要研究终点是血浆中HIV-1RNA浓度。

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. The purpose of this study is to compare the effectiveness of using increased doses of protease inhibitor (PI) drugs to continuing standard doses in lowering viral load. 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 a normalized inhibitory quotient (NIQ) helps control HIV infection better than not using NIQ and TDM drug levels and also to study the safety of increasing doses of PI drugs based on TDM. Subjects must have had at least two anti-HIV combinations of drugs, which included a PI that failed to control the HIV infection. Approximately 860 subjects will enroll into step 1, which will involve the selection of a salvage regimen. Of those, 450 subjects are expected to enter Step 2 to be randomized to one of three study arms: standard of care, standard of care with TDM, or observation. Subject participation is expected to last fourty-eight weeks. The primary study endpoint is the plasma HIV-1 RNA concentrations.