title: Low-dose oral recombinant interferon-alpha A in patients with HIV-1 infection: a blinded pilot study.
abstract: OBJECTIVE
  To evaluate the efficacy of low-dose oral recombinant interferon-alpha (IFN-alpha A) on clinical parameters, body weight, CD4+ lymphocyte counts and natural killer cell cytolytic activity in HIV-infected patients.
  
  
  METHODS
  Blinded crossover trial with controls for the protein and diluent components of the drug preparation.
  
  
  METHODS
  Medical school outpatient referral center.
  
  
  METHODS
  Eight patients with HIV-1 infection and a CD4+ lymphocyte count between 150 and 600 x 10(6)/l. Concurrent use of zidovudine was permitted.
  
  
  METHODS
  Patients received (daily, by mouth) 10 ml of a study solution of 2.5% albumin for 6 weeks, 150 IU IFN-alpha A for 6 weeks, and normal saline for 6 weeks.
  
  
  METHODS
  After two baseline visits, clinical assessments, vital signs, body weight, and laboratory tests, including enumeration of number and percentage of CD4+ and CD8+ lymphocytes and natural killer cell cytolytic activity, were performed every 3 weeks. Complete physical examinations were conducted every 6 weeks.
  
  
  RESULTS
  No significant clinical or laboratory changes were observed during treatment with IFN-alpha A. Peak CD4+ lymphocyte counts were achieved at baseline in one patient, during albumin treatment in two patients, during IFN-alpha A treatment in one patient, and during saline treatment in four patients. All patients remained HIV-seropositive. Treatments were well-tolerated.
  
  
  CONCLUSIONS
  This blinded pilot study of orally administered IFN-alpha A (150 IU daily for 6 weeks) did not demonstrate clinical benefit in HIV-infected patients.
authors.affiliation: Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey.
authors.forename: S J
authors.initials: SJ
authors.lastname: Sperber
authors.forename: D J
authors.initials: DJ
authors.lastname: Gocke
authors.forename: C A
authors.initials: CA
authors.lastname: Haberzettl
authors.forename: S
authors.initials: S
authors.lastname: Pestka
mesh_terms: D000284:Administration, Oral; D000328:Adult; D015496:CD4-Positive T-Lymphocytes; D003602:Cytotoxicity, Immunologic; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D015497:HIV-1; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007694:Killer Cells, Natural / Q000276:immunology; D007958:Leukocyte Count; D008297:Male; D011994:Recombinant Proteins
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins