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. KalMo Study: Switch to LPV/r monotherapy
Design
Randomisation
1 : 1
Open-label
W96
N = 30
60 HIV+ ≥ 18 years
On 2 NRTIs + (NNRTI or PI) > 6 months
HIV-1 RNA < 80 c/mL > 6 months
CD4 cell count > 200/mm3
Continuation of current regimen with 2 NRTIs + (NNRTI or PI)
N = 30
LPV/r 400/100 mg bid*
* 533/133 mg bid for the first 2 weeks if on NNRTI at screening
Endpoints
Primary endpoint: proportion of patients with HIV-1 RNA < 80 c/mL at W96 (ITT, missing equals failure analysis)
Secondary endpoints: virologic failure (2 consecutive HIV-1 RNA > 500 c/mL), AIDS-defining illnesses, CD4, safety, adverse events
KalMo
Nunes EP, HIV Clin Trials 2009;10:368-74

3. KalMo Study: Switch to LPV/r monotherapy
ARV-trial.com
KalMo Study: Switch to LPV/r monotherapy
Baseline characteristics and patient disposition
Triple therapy
N = 29
LPV/r bid monotherapy
N = 30
Age, median years 40 39
Female
31%
45%
Hepatitis C co-infection 3%
10%
CD4 cell count, median/mm3
510
538
Duration of ARV treatment, median months
43.4
40.5
PI treatment at screening
37%
33%
NNRTI treatment at screening
70%
63%
Discontinuation by W48, n 3 6
Discontinuation for adverse event
1 (diarrhoea)
Confirmed HIV RNA elevation 1
KalMo
Nunes EP, HIV Clin Trials 2009;10:368-74

4. KalMo Study: Switch to LPV/r monotherapy
Virologic outcome
Other outcomes
1 virologic failure (confirmed HIV-1 RNA > 500 c/mL) in each group. No resistance mutation on genotype
No difference in CD4 changes between groups
GI adverse events more frequent in the monotherapy group: 24 vs 10 (p = 0.001)
5 patients in the triple therapy group underwent regimen changes due to drug-related toxicities
Conclusion: switching to LPV/r monotherapy is effective, safe and well tolerated through 96 weeks
ITT analysis
HIV-1 RNA < 80 c/mL
On-treatment
analysis*
86.7 96 80 25 50 75
100
Triple therapy
LPV/r mono %
* Includes only patients who completed
96 weeks of follow-up without discontinuation
for other reasons than virologic failure
KalMo
Nunes EP, HIV Clin Trials 2009;10:368-74