Efficacy and safety of darunavir/ritonavir at 48 weeks in treatment-naïve, HIV-1-infected adolescents: Results from a Phase 2 open-label trial (DIONE)

BACKGROUND Twice-daily darunavir/ritonavir is indicated in treatment-experienced children (≥3 years). This study assessed once-daily administration in treatment-naive adolescents. METHODS Phase 2, 48-week, open-label, single-arm study evaluating pharmacokinetics, safety and efficacy of once-daily darunavir/ritonavir 800/100 mg in treatment-naive, HIV-1-infected adolescents (≥12 to