Author | DeJesus, Edwin | |
Author | McCarty, Debra | |
Author | Farthing, Charles F. | |
Author | Shortino, Denise D. | |
Author | Grinsztejn, Beatriz | |
Author | Thomas, Deborah A. | |
Author | Schrader, Shannon R. | |
Author | Castillo, Steve A. | |
Author | Sension, Michael G. | |
Author | Gough, Kevin | |
Author | Madison, Sam J. | |
Access date | 2019-01-28T11:56:43Z | |
Available date | 2019-01-28T11:56:43Z | |
Document date | 2004 | |
Citation | DEJESUS, Edwin et al. 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. Clinical Infectious Diseases, v. 39, p. 411-418, 2004. | pt_BR |
ISSN | 1058-4838 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/31318 | |
Language | eng | pt_BR |
Publisher | Oxford University Press | pt_BR |
Rights | restricted access | pt_BR |
Title | 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 | pt_BR |
Type | Article | |
DOI | 10.1086/422143 | |
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, >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. | pt_BR |
Affilliation | IDC Research Initiative. Altamonte Springs, FL, USA. | pt_BR |
Affilliation | GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA. | pt_BR |
Affilliation | AHF Research Center. Los Angeles, CA, USA. | pt_BR |
Affilliation | GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil. | pt_BR |
Affilliation | GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA. | pt_BR |
Affilliation | Montrose Clinic. Houston, TX, USA. | pt_BR |
Affilliation | GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA. | pt_BR |
Affilliation | North Broward Hospital District. Fort Lauderdale, FL, USA. | pt_BR |
Affilliation | St. Michael’s Hospital. Toronto, ON, Canada. | pt_BR |
Affilliation | GlaxoSmithKline. HIV Clinical Development and Medical Affairs. Research Triangle Park. NC, USA. | pt_BR |
Subject | HIV | pt_BR |
Subject | Antiretroviral | pt_BR |
Subject | Lamivudine | pt_BR |
Subject | Zidovudine | pt_BR |
Subject | Efavirenz | pt_BR |
e-ISSN | 1537-6591 | |
Embargo date | 2025-01-01 | |