40 likes | 248 Views
SWITCHMRK: Switching From Lopinavir/Ritonavir to Raltegravir. 2 randomized, double-blind studies SWITCHMRK 1 (n=348): European Union, Australia, North America SWITCHMRK 2 (n=354): Australia, North/Latin America, Africa, Southeast Asia Patients
E N D
SWITCHMRK: Switching From Lopinavir/Ritonavir to Raltegravir • 2 randomized, double-blind studies • SWITCHMRK 1 (n=348): European Union, Australia, North America • SWITCHMRK 2 (n=354): Australia, North/Latin America, Africa, Southeast Asia • Patients • Well-controlled patients on lopinavir/r bid + >2 NRTIs (and no other active PI) • No lipid lowering therapy for at least 12 weeks • Randomized groups • Continue lopinavir/r-based regimen • Switch to raltegravir + background antiretroviral regimen • Primary endpoints • Week 12: percent change in lipids • Week 24: proportion of patients with HIV RNA <50 copies/mL • Non-inferiority: +12% Eron J, et al. 16th CROI. Montreal, 2009. Abstract 70aLB.
SWITCHMRK:Week-24 Outcomes HIV RNA <50 Copies/mL CD4 Cell Change Raltegravir LPV/r Raltegravir LPV/r 94% 88% 87% 81% 17 CD4 Cell Change (cells/mm3) Patients (%) 7 5 5 SWITCHMRK 2 SWITCHMRK 1 SWITCHMRK 2 SWITCHMRK 1 HIV RNA <50 copies/mL: did not meet non-inferiority criteria. Eron J, et al. 16th CROI. Montreal, 2009. Abstract 70aLB.
SWITCHMRK:Week-12 Lipid Changes *P<0.001 versus LPV/r within each study. Eron J, et al. 16th CROI. Montreal, 2009. Abstract 70aLB.