Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects

G. Carosi, A. Lazzarin, H. Stellbrink, G. Moyle, S. Rugina, S. Staszewski, N. Givens, L. Ross, C. Granier, M. Ait-Khaled, D. Leather, W. G. Nichols

Research output: Contribution to journalArticle

Abstract

Purpose: Fosamprenavir/ritonavir 1400 mg/100 mg once-daily regimen may have a more favourable tolerability and lipid profile than the fosamprenavir/ ritonavir twice-daily regimen, while maintaining comparable antiviral efficacy. Methods: This open-label study had a group-sequential design with a stage 1 Week 24 futility analysis, with both efficacy and safety go-criteria for progression to stage 2. There were 214 antiretroviral-naive, HIV-1-infected subjects who were randomised to receive either fosamprenavir/ritonavir 1400 mg/100 mg once daily or fosamprenavir/ ritonavir 700 mg/100 mg twice daily, both with abacavir/lamivudine fixed-dose combination tablet. Primary endpoints were the proportion of subjects achieving HIV-1 RNA

Original languageEnglish
Pages (from-to)356-367
Number of pages12
JournalHIV Clinical Trials
Volume10
Issue number6
DOIs
Publication statusPublished - Jan 1 2009

Keywords

  • Abacavir
  • Fosamprenavir
  • HIV
  • Ritonavir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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    Carosi, G., Lazzarin, A., Stellbrink, H., Moyle, G., Rugina, S., Staszewski, S., Givens, N., Ross, L., Granier, C., Ait-Khaled, M., Leather, D., & Nichols, W. G. (2009). Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects. HIV Clinical Trials, 10(6), 356-367. https://doi.org/10.1310/hct1006-356