Rotterdam, and Academic Hospital. Maastricht. and LeiJenburg

Forty-five subjects with symptomatic human immunodeficiency virus type 1 (HIV-l) infec-tion, CD4 + lymphocyte counts of;:.150 X 106fL, and Karnofsky scores;:.60 were enrolled in a multicenter, randomized, controlled trial that compared zidovudine monotherapy and combina-tion therapy for 48 weeks with zidovudine and interferon-a (IFN-a). Zidovudine with IFN-a (n = 25) had a favorable effect on CD4+ cell counts compared with zidovudine alone (n = 20). At all time points analyzed, the mean change from baseline was higher, reaching significance at week 24 (+ 10 % versus-21 %; P =.029), At week 48 the difference was-12 % versus-45 % (P =.07). Anti-CD3 monoclonal antibody-induced T cell reactivity improved temporarily in both groups. Serum HIV p24 antigen levels decreased maximally during the first 12 weeks of treatment. At weeks 0 and 48, polymerase chain reaction analysis for mutations at codons 67 and 215 of the HIV-1 reverse transcriptase gene conferring zidovudine resistance was conducted in 10 subjects receiving zidovudine and in 8 subjects receiving combination therapy. At week 48, 1 of8 and 4 of 6 samples from the groups receiving zidovudine only or combination therapy, respectively, con