1. 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

2. 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

3. 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