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Lopinavir is a recently licensed peptidomimetic PI. In co-formulation with ritonavir, lopinavir levels exceed the IC50 of wild-type HIV by at least 75-fold. The role of lopinavir/ritonavir (lopinavir/r) in initial therapy is unclear.
This double-blind comparative trial randomized 686 patients to either co-formulated lopinavir/r (n=326) at a dose of 400/100 mg twice daily or nelfinavir (n=327) at 750 mg three times daily. All patients also received open-label 3TC + d4T. Eligible patients were HIV-infected, treatment-naive adults with a detectable viral load and a Karnofsky score of >70. Thirty-three patients who did not receive the study drug were excluded from analysis.
Study withdrawal before week 48 was less common in patients receiving lop…