title: Low-dose oral natural human interferon-alpha in 29 patients with HIV-1 infection: a double-blind, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To evaluate clinical efficacy and toxicity of low-dose oral natural human interferon-alpha (nHuIFN alpha) on CD4+ lymphocyte counts and clinical symptoms in patients with HIV-1 infection.
  
  
  METHODS
  Double-blind, randomized, placebo-controlled trial with crossover.
  
  
  METHODS
  Private practice specializing in the treatment of patients with AIDS.
  
  
  METHODS
  Only patients with HIV-1 infection and CD4+ lymphocyte counts between 200 and 500 x 10(6)/l were included for study. Thirty out of thirty-one patients at study entry completed treatment with placebo, and 29 completed nHuIFN alpha treatment. Mean patient age was 36 years (range, 25-58 years). The 30 patients included 26 men, of whom 22 were homosexual, and four women; five were drug users and none were currently on zidovudine therapy, although three had been previously.
  
  
  METHODS
  Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks.
  
  
  METHODS
  Every 2 weeks, a detailed history, physical examination, and laboratory tests, including CD4+ and CD8+ lymphocyte counts, were conducted.
  
  
  RESULTS
  There was only a slight, transient increase in mean CD4+ lymphocyte counts after 4 weeks of treatment with nHuIFN alpha, compared with a slight decline when placebo was administered. This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks. There were no significant changes in weight and clinical symptoms. All patients remained HIV-1-antibody-positive. Treatment-related adverse reactions were not observed.
  
  
  CONCLUSIONS
  Our double-blind, randomized, placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha. Although non-toxic, our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials.
authors.affiliation: Institute for Medical Oncology and Haematology (Project Group Biological Cancer Therapy), Nuremberg City Medical Center, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Kaiser
authors.forename: H
authors.initials: H
authors.lastname: Jaeger
authors.forename: J
authors.initials: J
authors.lastname: Birkmann
authors.forename: J
authors.initials: J
authors.lastname: Poppinger
authors.forename: J M
authors.initials: JM
authors.lastname: Cummins
authors.forename: W M
authors.initials: WM
authors.lastname: Gallmeier
mesh_terms: D000284:Administration, Oral; D000328:Adult; D015704:CD4 Antigens; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000276:immunology / Q000628:therapy*; D015497:HIV-1; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D016176:T-Lymphocyte Subsets / Q000276:immunology
chemical_list: D015704:CD4 Antigens; D016898:Interferon-alpha