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。 本研究的目的是比较使用增加剂量的蛋白酶抑制剂（PI）药物与持续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），其涉及测量PI的血液水平。 本研究还将观察使用归一化抑制商（NIQ）是否有助于控制HIV感染，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。 受试者必须接受至少两种抗HIV药物组合，其中包括未能控制HIV感染的PI。 约860例受试者将入组第1步，这将涉及挽救治疗方案的选择。 其中，450例受试者预计将进入第2步，随机分配至三个研究组之一：标准治疗、标准治疗+TDM或观察。 受试者参与预计持续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 fourty-eight weeks. The primary study endpoint is the plasma HIV-1 RNA concentrations.