ACTG A5146:IMPACT OF THERAPEUTIC DRUG MONITORING (TDM) ON VIROLOGIC RESPONSE

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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. This study will compare the effectiveness and safety of using increased doses of protease inhibitor (PI) drugs to continuing standard doses of PIs in lowering viral load (amount of HIV in the blood). 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 an NIQ (normalized inhibitory quotient), a new way of using TDM to adjust the levels of anti HIV drug in the blood, helps control HIV infection better than not using the NIQ and TDM drug levels. Antiretroviral regimens will be selected and prescribed by the subject's clinician based on the results of the resistance testing. All subjects must initiate a salvage regimen at study entry that contains a PI at protocol-specified doses. Antiretroviral drugs will not be provided by this protocol. A5146 will provide resistance testing at baseline and for subjects who have confirmed HIV-1 RNA ¿ 1000 copies/mL at or after week 24.