BACKGROUND AND OBJECTIVE: HIV protease inhibitors (PI) were licensed without a direct evidence of their relative efficacy. PATIENTS AND METHOD: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. RESULTS: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. CONCLUSIONS: No differences were observed in the effectiveness of SQV, IDV and RTV.
RCT Entities:
BACKGROUND AND OBJECTIVE: HIV protease inhibitors (PI) were licensed without a direct evidence of their relative efficacy. PATIENTS AND METHOD: 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. RESULTS: 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. CONCLUSIONS: No differences were observed in the effectiveness of SQV, IDV and RTV.
Authors: Susan M Watanabe; Viviana Simon; Natasha D Durham; Brittney R Kemp; Satoshi Machihara; Kimdar Sherefa Kemal; Binshan Shi; Brian Foley; Hongru Li; Benjamin K Chen; Barbara Weiser; Harold Burger; Kathryn Anastos; Chaoping Chen; Carol A Carter Journal: Retrovirology Date: 2016-09-06 Impact factor: 4.602