A randomized, controlled trial of indinavir, zidovudine, and lamivudine inadults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy

A randomized, double-blind, multicenter study of indinavir, zidovudine, and lamivudine was conducted in 320 adults with human immunodeficiency virus t ype 1 (HIV-1) infection, less than or equal to 50 CD4 cells/mm(3), and exte nsive prior zidovudine therapy. Patients received indinavir, 800 mg every 8 h; zidovudine, 200 mg every 8 h, and lamivudine, 150 mg twice daily; or al l 3 drugs for 24 weeks, In an intention-to-treat analysis, proportions of p atients with HIV-1 RNA <500 and <50 copies/mL, respectively, at week 24 wer e 56% and 45% in the indinavir-zidovudine-lamivudine group, 3% and 2% in th e indinavir group, and 0% in the zidovudine-lamivudine group, Observed mean CD4 cell increases were 95, 78, and 6 cells/mm(3) in the three-, one-, and two-drug arms, respectively. Regimens were generally well tolerated. Patie nts with advanced HIV-1 infection benefit from triple therapy with indinavi r, zidovudine, and lamivudine, although the proportion with optimal respons e appeared to be lower in patients with low CD4 cell counts.