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

Dejesus, Edwin; McCarty, Debra; Farthing, Charles F.; Shortino, Denise D.; Grinsztejn, Beatriz; Thomas, Deborah A.; Schrader, Shannon R.; Castillo, Steve A.; Sension, Michael G.; Gough, Kevin; Madison, Sam J.
August 2004
Clinical Infectious Diseases;8/1/2004, Vol. 39 Issue 3, p411
Academic Journal
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 <400 copies/mL was within the bound of -12% to 12%. At week 48 of the study, an intent-to-treat analysis in which patients with missing data were considered to have experienced treatment failure showed that the 3TC q.d. and 3TC b.i.d. regimens were equivalent (HIV-1 RNA level <400 copies/mL, 178 [64%] of 278 vs. 174 [63%] of 276; treatment difference, 1% [95% CI, -7.1% to 8.9%]; HIV-1 RNA level <50 copies/mL, 165 [59%] of 278 vs. 168 [61%] of 276; treatment difference, 1.7% [95% CI, -9.7% to 6.6%]). Median increase above baseline in CD4+ 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.


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