Treatment with Amprenavir Alone or Amprenavir with Zidovudine and Lamivudine in Adults with Human Immunodeficiency Virus Infection

Authors:
  • RGRoy M. Gulick
    Roy M. Gulick
  • VDVictor DeGruttola
    Victor DeGruttola
  • RDRichard T. D'Aquila
    Richard T. D'Aquila
  • JEJoseph J. Eron
    Joseph J. Eron
  • JSJean-Pierre Sommadossi
    Jean-Pierre Sommadossi
  • JCJudith S. Currier
    Judith S. Currier
  • LSLaura Smeaton
    Laura Smeaton
  • IFIan Frank
    Ian Frank
  • ACAngela M. Caliendo
    Angela M. Caliendo
  • JGJohn G. Gerber
    John G. Gerber
  • RTRoger Tung
    Roger Tung
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Abstract
Amprenavir is a human immunodeficiency virus (HIV) protease inhibitor with a favorable pharmacokinetic profile and good in vitro activity. Ninety-two lamivudine- and protease inhibitor-naive individuals with ⩾50 CD4 cells/mm3 and ⩾5000 HIV RNA copies/mL were assigned amprenavir (1200 mg) alone or with zidovudine (300 mg) plus lamivudine (150 mg), all given every 12 h. After a median follow-up of 88 days, the findings of a planned interim review resulted in termination of the amprenavir monotherapy arm. Among 85 subjects with confirmed plasma HIV RNA determination, 15 of 42 monotherapy versus 1 of 43 triple-therapy subjects had an HIV RNA increase above baseline or 1 log10 above nadir (P = .0001). For subjects taking triple therapy at 24 weeks, the median decrease in HIV RNA was 2.04 log10 copies/mL, and 17 (63%) of 27 evaluable subjects had <500 HIV RNA copies/mL. Treatment with amprenavir, zidovudine, and lamivudine together reduced the levels of HIV RNA significantly more than did amprenavir monotherapy.