Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection

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 greater than or equal to 50 CD4 cells/mm(3) and greater than or equal to 5000 HN RNA copies /mL were assigned amprenavir (1200 mg) alone or with zidovudine (300 mg) pl us lamivudine (150 mg), all given every 12 h. After a median follow-up of s s days, the findings of a planned interim review resulted in termination of the amprenavir monotherapy arm. Among 85 subjects with confirmed plasma HI V RNA determination, 15 pf 42 monotherapy versus 1 of 43 triple-therapy sub jects had an HIV RNA increase above basline or 1 log(10) above nadir (P=.00 01). For subjects taking triple therapy at 24 weeks, the median decrease in HIV RNA was 2.04 log(10) copies/mL, and 17 (63%) of 27 evaluable subjects had <500 HIV RNA copies/mL;. Treatment: with amprenavir, zidovudine, and la mivudine together reduced he levels of HIV RNA significantly more than did amprenavir monotherapy.