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( ARTG ) EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/mL at baseline.‍‍‍‍‍‍​​​‍​​​​​​ This indication is based on Week 48 safety and efficacy analyses from 2 randomised double-blind, controlled Phase III trials in treatment-naive adult patients and on Week 96 safety and efficacy analyses from the Phase IIb trial TMC278-C204 in treatment-naive adult patients (see CLINICAL TRIALS section).