Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: A 3-year randomized trial

Joel E. Gallant, Schlomo Staszewski, Anton L. Pozniak, Edwin DeJesus, Jamal M A H Suleiman, Michael D. Miller, Dion F. Coakley, Biao Lu, John J. Toole, Andrew K. Cheng

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Abstract

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

Original languageEnglish (US)
Pages (from-to)191-201
Number of pages11
JournalJournal of the American Medical Association
Volume292
Issue number2
DOIs
StatePublished - Jul 14 2004

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Gallant, J. E., Staszewski, S., Pozniak, A. L., DeJesus, E., Suleiman, J. M. A. H., Miller, M. D., Coakley, D. F., Lu, B., Toole, J. J., & Cheng, A. K. (2004). Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: A 3-year randomized trial. Journal of the American Medical Association, 292(2), 191-201. https://doi.org/10.1001/jama.292.2.191