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ArtículoDerechos de autor
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Fecha del embargo
2025-01-01
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- INI - Artigos de Periódicos [3397]
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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
Autor
Afiliación
IDC Research Initiative. Altamonte Springs, FL, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
AHF Research Center. Los Angeles, CA, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
Montrose Clinic. Houston, TX, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
North Broward Hospital District. Fort Lauderdale, FL, USA.
St. Michael’s Hospital. Toronto, ON, Canada.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
AHF Research Center. Los Angeles, CA, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
Montrose Clinic. Houston, TX, USA.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
North Broward Hospital District. Fort Lauderdale, FL, USA.
St. Michael’s Hospital. Toronto, ON, Canada.
GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA.
Resumen en ingles
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, >or=400 copies/mL; CD4(+) cell count, >100 cells/mm(3)) 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/mm(3); b.i.d. group, +146 cells/mm(3)), and the incidences of adverse events, disease progression, and HIV-associated conditions were comparable.
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