Virologic and immunologic outcomes of HIV-infected Ugandan children randomized to lopinavir-ritonavir or nonnucleoside-reverse-transcriptase-inhibitor therapy. In the PROMOTE-pediatrics trial, HIV-infected Ugandan children randomized to receive lopinavir-ritonavir (LPV/r)-based antiretroviral therapy (ART) experienced a lower incidence of malaria compared to children receiving non-nucleoside-reverse-transcriptase-inhibitor (NNRTI)-based-ART. Here we present the results of the non-inferiority (NI) analysis of virologic efficacy and comparison of immunologic outcomes. ART-naïve or -experienced (HIV RNA < 400 copies/ml) children ages 2 months to 6 years received either LPV/r or NNRTI-based-ART. The proportion of children with virologic suppression (HIV RNA <400copies/ml) at 48 weeks was compared using a pre-specified NI margin of -11% in per-protocol analysis. Time to virologic failure by 96 weeks, change in CD4 counts and percentages, and incidence of adverse event rates were also compared.
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