Ensayo clínico comparativo, aleatorizado y abierto sobre la efectividad de indinavir, ritonavir y saquinavir

Abstract

HIV protease inhibitors (PI) were licensed without a direct evidence of their relative efficacy. 137 patients attending our clinics between November 1997 and March 1998, to whom treatment with a PI was recommended, were randomized to receive indinavir (IDV), saquinavir (SQV) or ritonavir (RTV). Main outcome variables were one-year mean changes in HIV-RNA plasma concentrations and CD4 cells counts and proportion of patients with HIV viral load below level of detection. Mean HIV viral load reductions were 0.95 for SQV, 0.72 for IDV and 0.65 for RTV (p = 0.44), equaling losses and changes to failures. In a standard intent-to-treat analysis, mean changes in viral load were 1.16, 1.01 and 1.50 (p = 0.21), respectively. The proportion of patients with undetectable viral load was 50%, with no differences between treatment arms. No differences were observed in the effectiveness of SQV, IDV and RTV.