TY - JOUR
T1 - Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART
AU - Bonjoch, Anna
AU - Paredes, Roger
AU - Galvez, Juan
AU - Miralles, Celia
AU - Videla, Sebastia
AU - Martínez, Eva
AU - Miranda, Jose
AU - Muñoz-Moreno, Jose Antonio
AU - De La Torre, Javier
AU - Prieto, Arturo
AU - Vilades, Consuelo
AU - Clotet, Bonaventura
PY - 2005/7/1
Y1 - 2005/7/1
N2 - Objectives: To assess the virologic noninferiority of an antiretroviral treatment simplification with coformulated zidovudine/lamivudine/abacavir (group 1) vs. coformulated zidovudine/lamivudine plus nevirapine (group 2) in HIV-1-infected patients receiving successful firstline highly active antiretroviral therapy. Methods: This is a prospective, multicenter, open-label, comparative, randomized, noninferiority study. A delta of 15% for differences in virologic suppression <200 copies/mL between groups was pre-specified with a 1-sided 0.025 significance level. Results: A total of 134 patients were included into this study: 68 were allocated to group 1 and 66 to group 2. By intention-to-treat analysis (switch equals failure), the percentage of virologic suppression <200 copies/mL (<50 copies/mL) at week 48 was 71.0% (65.1%) and 73.0% (63.3%) in groups 1 and 2, respectively (estimate for differences [<200 copies/mL]: -2.1, 95% CI: -17.4-13.1, P = 0.783). Thirteen and 14 patients in groups 1 and 2, respectively, discontinued therapy due to adverse events. Dyslipidemia improved in both groups, with a higher improvement in low-density lipoprotein cholesterol (P = 0.049) in group 1. Conclusions: Group 1 is not inferior to group 2 regarding virologic suppression <200 copies/mL. Both strategies improve lipid profile. Copyright © 2005 by Lippincott Williams & Wilkins.
AB - Objectives: To assess the virologic noninferiority of an antiretroviral treatment simplification with coformulated zidovudine/lamivudine/abacavir (group 1) vs. coformulated zidovudine/lamivudine plus nevirapine (group 2) in HIV-1-infected patients receiving successful firstline highly active antiretroviral therapy. Methods: This is a prospective, multicenter, open-label, comparative, randomized, noninferiority study. A delta of 15% for differences in virologic suppression <200 copies/mL between groups was pre-specified with a 1-sided 0.025 significance level. Results: A total of 134 patients were included into this study: 68 were allocated to group 1 and 66 to group 2. By intention-to-treat analysis (switch equals failure), the percentage of virologic suppression <200 copies/mL (<50 copies/mL) at week 48 was 71.0% (65.1%) and 73.0% (63.3%) in groups 1 and 2, respectively (estimate for differences [<200 copies/mL]: -2.1, 95% CI: -17.4-13.1, P = 0.783). Thirteen and 14 patients in groups 1 and 2, respectively, discontinued therapy due to adverse events. Dyslipidemia improved in both groups, with a higher improvement in low-density lipoprotein cholesterol (P = 0.049) in group 1. Conclusions: Group 1 is not inferior to group 2 regarding virologic suppression <200 copies/mL. Both strategies improve lipid profile. Copyright © 2005 by Lippincott Williams & Wilkins.
KW - Antiretroviral simplification
KW - Coformulated zidovudine/ lamivudine/abacavir
KW - Coformulated zidovudine/lamivudine
KW - HIV-1
KW - Nevirapine
KW - Noninferiority study
U2 - 10.1097/01.qai.0000164249.33851.3a
DO - 10.1097/01.qai.0000164249.33851.3a
M3 - Article
VL - 39
SP - 313
EP - 316
IS - 3
ER -