Switch to LPV/r monotherapy ARV-trial.com Switch to LPV/r monotherapy Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077 1

Pilot Study: Switch to LPV/r monotherapy Design Open-label Single-arm Pilot trial W48 HIV+ ≥ 18 years On ARV therapy with NNRTI PI-naïve HIV-1 RNA < 75 c/mL N = 18 Switch to LPV/r 400/100 mg bid monotherapy Primary endpoint Proportion of patients with HIV-1 RNA < 75 c/mL at W48 Virologic failure = 2 consecutive HIV-1 RNA > 400 c/mL PILOT LPV/r Pierone G, HIV Clinical Trials;2006;7:237-45

Pilot Study: Switch to LPV/r monotherapy Median of prior ARV therapy was 122 weeks EFV: 22% NVP: 78% Median CD4 cell count/mm3 at inclusion = 272 ; at nadir = 177 5 patients discontinued before W48 3 for diarrhoea 2 for virologic failure (no emergence of resistance) HIV-1 RNA < 75 c/mL at W48: 12/18 patients (66%), 12/13 who completed 48 weeks of follow-up Adverse events: 2 patients developed diabetes mellitus, 7 required introduction or increase in lipid-lowering agents Conclusion Pilot study of LPV/r monotherapy suggests maintaining virological success with switch in the majority of patients PILOT LPV/r Pierone G, HIV Clinical Trials;2006;7:237-45