TY - JOUR
T1 - Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients
T2 - A 3-year randomized trial
AU - Gallant, Joel E.
AU - Staszewski, Schlomo
AU - Pozniak, Anton L.
AU - DeJesus, Edwin
AU - Suleiman, Jamal M A H
AU - Miller, Michael D.
AU - Coakley, Dion F.
AU - Lu, Biao
AU - Toole, John J.
AU - Cheng, Andrew K.
PY - 2004/7/14
Y1 - 2004/7/14
N2 - Context: Tenofovir disoproxil fumarate (DF) is a once-daily nucleotide analogue reverse transcriptase inhibitor. Objective: To evaluate the efficacy and safety of tenofovir DF compared with stavudine in antiretroviral-naive patients. Design, Setting, and Participants: A prospective, randomized, double-blind study conducted at 81 centers in the United States, South America, and Europe from June 9, 2000, to January 30, 2004. A total of 753 patients infected with HIV who were antiretroviral naive were screened and 602 patients entered the study. Intervention Patients were randomized to receive either tenofovir DF (n=299) or stavudine (n=303), with placebo, in combination with lamivudine and efavirenz. Main Outcome Measure: Proportion of patients with HIV RNA levels of less than 400 copies/mL at week 48. Results: In the primary intent-to-treat analysis in which patients with missing data or who added or switched antiretroviral medications before week 48 were considered as failures, the proportion of patients with HIV RNA of less than 400 copies/mL at week 48 was 239 (80%) of 299 in patients receiving tenofovir DF and 253 (84%) of 301 in patients receiving stavudine (95% confidence interval, -10.4% to 1.5%), exceeding the predefined -10% limit for equivalence. However, equivalence was demonstrated in the secondary analyses (HIV RNA
AB - Context: Tenofovir disoproxil fumarate (DF) is a once-daily nucleotide analogue reverse transcriptase inhibitor. Objective: To evaluate the efficacy and safety of tenofovir DF compared with stavudine in antiretroviral-naive patients. Design, Setting, and Participants: A prospective, randomized, double-blind study conducted at 81 centers in the United States, South America, and Europe from June 9, 2000, to January 30, 2004. A total of 753 patients infected with HIV who were antiretroviral naive were screened and 602 patients entered the study. Intervention Patients were randomized to receive either tenofovir DF (n=299) or stavudine (n=303), with placebo, in combination with lamivudine and efavirenz. Main Outcome Measure: Proportion of patients with HIV RNA levels of less than 400 copies/mL at week 48. Results: In the primary intent-to-treat analysis in which patients with missing data or who added or switched antiretroviral medications before week 48 were considered as failures, the proportion of patients with HIV RNA of less than 400 copies/mL at week 48 was 239 (80%) of 299 in patients receiving tenofovir DF and 253 (84%) of 301 in patients receiving stavudine (95% confidence interval, -10.4% to 1.5%), exceeding the predefined -10% limit for equivalence. However, equivalence was demonstrated in the secondary analyses (HIV RNA
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U2 - 10.1001/jama.292.2.191
DO - 10.1001/jama.292.2.191
M3 - Article
C2 - 15249568
AN - SCOPUS:3042848853
SN - 0098-7484
VL - 292
SP - 191
EP - 201
JO - Journal of the American Medical Association
JF - Journal of the American Medical Association
IS - 2
ER -