Randomized, placebo-controlled, double-blind study of low-dose oral interferon-αin HIV-1 antibody positive patients

One hundred forty-nine patients of private physicians in Toronto, Canada, who were positive for human immunodeficiency virus (HIV), medically stable, and had CD4 cell counts of <700 cells/mm³ participated in a randomized, double-blind trial of placebo versus low-dose (50 U) versus highdose (100 U) oral interferon-α. Treatment allocation was balanced according to baseline CD4 cell count and history of prior antiviral therapy. Patients were observed at 4 and 8 weeks for assessment of adverse events and several measures of disease status, including CD4 cell count, β₂-microglobulin, weight, and Karnofsky score. We detected neither short-term benefits nor adverse effects from oral interferon-a therapy.