This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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 salvageregimen. Subjects 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 before week 4, in order to determine eligibility for randomization into Step 2. Step 2 consists of 3 arms: standard of care, TDM plus standard of care, and an Observation a1 arm.The primary objective is to compare the mean change in plasma HIV-RNA from Step 2 entry (week 4) to week 24 between the TDM+SOC and SOC randomized arms and to characterize the mean change in plasma HN-1 RNA from salvage therapy initiation (week 0) to week 24.
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