Once-Daily versus Twice-Daily Lamivudine, in Combination with Zidovudine and Efavirenz, for the Treatment of Antiretroviral-Naive Adults with HIV Infection: A Randomized Equivalence Trial

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Abstract
A randomized, double-blind, double-dummy controlled, multicenter trial was conducted that involved 554 antiretroviral-naive human immunodeficiency virus—infected adults (plasma HIV type 1 [HIV-1] RNA level, ⩾400 copies/mL; CD4+ cell count, >100 cells/mm3) and compared a 300-mg once-daily (q.d.) regimen of lamivudine (3TC) versus a 150-mg twice-daily (b.i.d.) regimen of 3TC, combined with zidovudine (300 mg b.i.d.) and efavirenz (600 mg q.d.), during a 48-week period. Treatments were considered equivalent if the 95% confidence interval (CI) for the difference in proportions of patients achieving an HIV-1 RNA level of + cell count was similar (q.d. group, +144 cells/mm3; b.i.d. group, +146 cells/mm3), and the incidences of adverse events, disease progression, and HIV-associated conditions were comparable.