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

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。本研究的目的是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降低病毒载量的有效性。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。本研究还将研究使用标准化抑制商（NIQ）是否比不使用NIQ和TDM药物水平更有助于控制HIV感染，并研究基于TDM增加PI药物剂量的安全性。受试者必须服用至少两种抗HIV药物组合，其中包括一种无法控制HIV感染的PI。大约860名受试者将被纳入第一步，这将包括选择挽救方案。其中，450名受试者预计将进入第二步，随机分为三个研究组：标准护理组、TDM标准护理组或观察组。受试者参与预计将持续48周。主要研究终点是血浆HIV-1 RNA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 forty-eight weeks. The primary study endpoint is the plasma HIV-1 RNA concentrations.