IMPACT OF THERAPEUTIC DRUG MONITORING ON VIROLOGIC RESPONSE TO A SALVAGE REGIMEN

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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. 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 forty-eight weeks. The primary study endpoint is the plasma HIV-1 RNA concentrations.