ACTG A5146: THERAPEUTIC DRUG MONITORING IN SUBJECTS WITH A LOW NIQ TO PIS (AIDS)

点击翻译按钮获取中文摘要

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 is an open-label, randomized, multicenter study to evaluate the impact of therapeutic drug monitoring (TDM) on HIV virologic response to salvage regimens in protease-inhibitor-experienced subjects who have a low normalized inhibitory quotient (NIQ) to at least one of the protease inhibitors (PI) in their salvage regimen. Patients failing therapy will be started on a new antiretroviral therapy regimen and retested at 4 weeks. If the NIQ is equal to or less than 1, then they will be randomized into one of 3 arms: standard of care (SOC), SOC plus TDM, and observational. They will be followed for 48 weeks. The primary objective is to assess HIV viral load at 24 weeks. This is a clinically relevant, important study on how to optimize management of patients who failed therapy. This study has been initiated on the GCRC and is ongoing.