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lüll Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection Gulick RM; Ribaudo HJ; Shikuma CM; Lustgarten S; Squires KE; Meyer WA 3rd; Acosta EP; Schackman BR; Pilcher CD; Murphy RL; Maher WE; Witt MD; Reichman RC; Snyder S; Klingman KL; Kuritzkes DRN Engl J Med 2004[Apr]; 350 (18): 1850-61BACKGROUND: Regimens containing three nucleoside reverse-transcriptase inhibitors offer an alternative to regimens containing nonnucleoside reverse-transcriptase inhibitors or protease inhibitors for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection, but data from direct comparisons are limited. METHODS: This randomized, double-blind study involved three antiretroviral regimens for the initial treatment of subjects infected with HIV-1: zidovudine-lamivudine-abacavir, zidovudine-lamivudine plus efavirenz, and zidovudine-lamivudine-abacavir plus efavirenz. RESULTS: We enrolled a total of 1147 subjects with a mean baseline HIV-1 RNA level of 4.85 log10 (71,434) copies per milliliter and a mean CD4 cell count of 238 per cubic millimeter were enrolled. A scheduled review by the data and safety monitoring board with the use of prespecified stopping boundaries led to a recommendation to stop the triple-nucleoside group and to present the results in the triple-nucleoside group in comparison with pooled data from the efavirenz groups. After a median follow-up of 32 weeks, 82 of 382 subjects in the triple-nucleoside group (21 percent) and 85 of 765 of those in the combined efavirenz groups (11 percent) had virologic failure; the time to virologic failure was significantly shorter in the triple-nucleoside group (P<0.001). This difference was observed regardless of the pretreatment HIV-1 RNA stratum (at least 100,000 copies per milliliter or below this level; P< or =0.001 for both comparisons). Changes in the CD4 cell count and the incidence of grade 3 or grade 4 adverse events did not differ significantly between the groups. CONCLUSIONS: In this trial of the initial treatment of HIV-1 infection, the triple-nucleoside combination of abacavir, zidovudine, and lamivudine was virologically inferior to a regimen containing efavirenz and two or three nucleosides.|*HIV-1/genetics[MESH]|Adult[MESH]|Aged[MESH]|Alkynes[MESH]|Benzoxazines[MESH]|CD4 Lymphocyte Count[MESH]|Cyclopropanes[MESH]|Dideoxynucleosides/adverse effects/therapeutic use[MESH]|Double-Blind Method[MESH]|Drug Resistance, Viral/genetics[MESH]|Drug Therapy, Combination[MESH]|Female[MESH]|Follow-Up Studies[MESH]|HIV Infections/*drug therapy[MESH]|Humans[MESH]|Lamivudine/therapeutic use[MESH]|Male[MESH]|Middle Aged[MESH]|Nucleosides/*therapeutic use[MESH]|Oxazines/adverse effects/*therapeutic use[MESH]|RNA, Viral/blood[MESH]|Reverse Transcriptase Inhibitors/adverse effects/*therapeutic use[MESH]|Zidovudine/adverse effects/therapeutic use[MESH] |