A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease
Condition: Anemia; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Anemia; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus
      placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients
      with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is
      a genetically engineered protein that stimulates red blood cell production.
    

Detailed description: 
      It is estimated that approximately 75% to 80% of patients with AIDS experience anemia, which
      can be caused by AIDS or by the therapy patients receive for AIDS treatment (for example,
      AZT). Anemia is a condition in which a patient has below normal levels of hemoglobin, the
      substance in red blood cells that carries oxygen to all parts of the body. People with severe
      anemia may experience fatigue and shortness of breath with activity. Therefore, this
      condition can have a negative influence on a person's quality of life. Epoetin alfa, used to
      treat anemia, is a genetically engineered form of a natural hormone, erythropoietin, that
      stimulates red blood cell production. This is a randomized, double-blind, placebo-controlled,
      parallel group study with an open-label follow-up period that is designed to evaluate the
      safety and effectiveness of epoetin alfa treatment in patients with AIDS who are being
      treated with AZT. The study consists of 3 periods: a screening period to determine if
      patients are eligible for the study, a double-blind period, and an open-label period.
      Eligible patients will be randomly assigned to one of two groups: a group receiving epoetin
      alfa 100 U/kg or a group receiving matching placebo. Patients will be treated with study
      medication injected under the skin 3 times per week for 12 weeks (or until their hematocrit
      reaches 38% to 40%). In the open-label period, all patients receive epoetin alfa injected
      under the skin for up to 6 months. Effectiveness will be determined by the change in
      hemoglobin, hematocrit, and reticulocytes (laboratory tests used to evaluate the severity of
      anemia), transfusion requirements, the patient's quality of life assessment, and the
      physician's global evaluation of the drug effect. Safety assessments include the incidence
      and severity of adverse events during the study, and changes in clinical laboratory tests
      (hematology, biochemistry, and urinalysis), vital signs, electrocardiograms (ECGs), and
      physical examination findings. The study hypothesis is that AIDS patients who are receiving
      AZT and who are treated with epoetin alfa will have a lower incident of anemia compared with
      patients receiving placebo. Double-blind: epoetin alfa (100 U/kg) or placebo given under the
      skin 3 times a week for 12 weeks or until hematocrit reaches 38% to 40%. Open-label: epoetin
      alfa 150 U/kg 3 times a week for up to 6 months (once weekly after hematocrit reaches 38% to
      40%). Dosage may be adjusted up to 300 U/kg.
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anemia; AIDS; HIV; Zidovudine; Quality of Life; erythropoietin; epoetin alfa