A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients

Abstract

To compare one protease inhibitor (PI)-based and two PI-sparing antiretroviral therapy regimens. International, open label, randomized study of antiretroviral drug-naive patients, with CD4 lymphocyte counts ≥ 200 × 106 cells/l and plasma HIV-1 RNA levels > 500 copies/ml. Treatment assignment to stavudine and didanosine plus indinavir or nevirapine or lamivudine. Primary study endpoint was the percentage of patients with plasma HIV-1 RNA levels Results: In total, 298 patients were enrolled. After 48 weeks, the percentage of patients in the indinavir, nevirapine and lamivudine arms with HIV-1 RNA Conclusions: A comparable virological response can be achieved with first-line PI-base and PI-sparing regimens. The triple nucleoside regimen utilized may be less likely to result in viral suppression to