A5146 A RANDOMIZED-CONTROLLED TRIAL EVALUATING THE IMPACT OF TDM

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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 evaluating the impact of therapeutic drug monitoring (TDM) on virologic response to a salvage regimen in protease inhibitor (PI)-experienced subjects who have a low normalized inhibitory quotient (NIQ)* to at least one of the PIs in their salvage regimen. Subjects with HIV failing their second, third, or fourth combination antiretroviral regimen will have a screening resistance test performed using a virtual phenotype while they remain on their failing regimen. At entry, all subjects will enter Step 1, in which a salvage regimen will be selected by the subject's clinician using results of this resistance test. All subjects will have timed plasma samples obtained for PI trough levels on the new regimen at week 2, and will receive results of their NIQ (1 or 1 in Arm C).