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. A5086 is an open-label, prospective, randomized, multicenter clinical trial evaluating a strategy of therapy interruption prior to modification of antiretroviral therapy in heavily pretreated subjects failing current potent combination antiretroviral therapy. Subjects with confirmed plasma HIV-1 RNA levels >10,000 copies/mL and CD4+ T-lymphocyte counts >150 cells/ L on their current antiretroviral therapy will have pre-entry plasma samples tested for HIV drug resistance genotype and phenotype. Subjects will be instructed to remain on their current therapy between screening and randomization pending the results of these analyses. Based on the results of the pre-entry genotype and phenotype tests and treatment history, an individualized salvage therapy regimen will be selected by the site investigator(s). The salvage regimen will consist of a best available multiple-drug regimen including new or recycled drugs (allowing investigational or expanded access drugs where available). Site investigators will be required to record the selected salvage therapy regimen prior to randomization and to prescribe that regimen at the time of salvage therapy initiation.
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