Kaletra lopinavir/ritonavir: Phase III data

Researchers at the University of California, San Francisco, and colleagues reported data from the open-label, Ugandan Phase III PROMOTE-PEDS trial in 176 HIV-infected children ages 2 months to 5 years showing that Kaletra plus 2 nucleoside analog reverse transcriptase inhibitors (NRTIs) met the primary endpoint of reducing the incidence of malaria vs. nevirapine or efavirenz plus 2 NRTIs (1.32 vs. 2.25 episodes per person-year, p=0.04). Additionally, patients who received Kaletra plus 2 NRTIs had a significant reduction in the incidence of malaria recurrence after treatment with artemether/lumefantrine vs. patients who received nevirapine or efavirenz plus 2 NRTIs (28.1% vs. 54.2%, p=0.004). The trial was funded by NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development. Data were published in the New England Journal of Medicine. ...