A randomized study investigating the efficacy and safety of amprenavir in combination with low-dose ritonavir in protease inhibitor-experienced HIV-infected adults

Objectives. To compare the safety and efficacy of amprenavir [APV/j Agenerase™; GlaxoSmithKline, [Ware, UK; 600 mg twice a day (bid)] boosted with low-dose ritonavir (RTV, 100 mg bid) with those of other protease inhibitors (PIs) in PI-experienced HIV-infected patients. Study design. Parallel-group, randomized, open-label, multicentre study. Methods. One hundred and sixty-three patients with HIV predicted to be sensitive to APV, another PI and a nucleoside reverse transcriptase inhibitor (NRTI) were randomly assigned to receive either APV boosted with low-dose RTV (APV/r) or a standard of care (SOC) PI with or without low-dose RTV. The non-inferiority of APV/r to the SOC PIs was assessed by time-weighted average change from baseline (AAUCMB) in plasma viral load (vRNA) at week 16. Results. The antiviral response for APV/r bid was non-inferior to that for the SOC PI group: the vRNA AAUCMB mean treatment difference was 0.043 log10 HIV-1 RNA copies/mL [95% confidence interval (CI) - 0.250, 0.335]. APV/r bid was generally well tolerated. Conclusions. Results confirm the antiviral activity, short-term safety and tolerability of APV/r bid in PI-experienced patients. © 2004 British HIV Association.