This study will explore whether a four-drug regimen will be more successful than a three-drug regimen in suppressing HIV-1 replication in patients with advanced disease (CD4 <200 cells/mm3) or with very high virus leads (plasma HIV-1 RNA > 100,000 copies/mL.) Preliminary data suggest that protease inhibitor combinations result in substantial suppression of HIV replication, as measured by the proportion with plasma HIV RNA levels below the level of quantitation in the circulation and are well tolerated. Three-drug regimens that include non-nucleoside reverse transcriptase inhibitors (NNRTI) also result in profound suppression of HIV replication. Based on these data, it may be possible to generate more potent antiretroviral drug regimens that will result in more durable suppression of viral replication, without the emergence of viral resistance. Thus, the evaluation of more complex combination regimens appears to be warranted in the treatment of patients with advanced HIV disease. The purpose of this study is to determine the virologic benefits and safety of either NFV or EFZ in combination with IDV and 3TC 150 mg/ZDV 300 mg in the treatment of subjects with advanced HIV disease who have received limited or no prior antiretroviral therapy.
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