RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY OF LOW-DOSE ORAL INTERFERON-ALPHA IN 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 high-dose (100 U) oral interferon-alpha. 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, beta2-microglobulin, weight, and Karnofsky score. We detected neither short-term benefits nor adverse effects from oral interferon-alpha therapy.