A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused by the Disease and by Zidovudine (AZT) Therapy
Condition: Acquired Immunodeficiency Syndrome; Anemia
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Anemia; Immunologic Deficiency Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus
      placebo in AIDS patients for the treatment of anemia that is a result of the disease or a
      result of zidovudine (AZT) treatment for AIDS. 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,
      zidovudine [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 study with an open-label follow-up period that is designed
      to evaluate the safety and effectiveness of epoetin alfa treatment compared with placebo
      treatment in patients with AIDS who are being treated with AZT. The study consists of three
      periods: a screening period to determine if patients are eligible for the study, a
      double-blind period, and an open-label period. During the double-blind period, patients are
      randomly assigned to one of two groups and receive either epoetin alfa (100 units per
      kilogram) or placebo injected into a vein (intravenously) three 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 (subcutaneously) for up to 6 months at the dose needed
      to maintain hematocrit levels of 38% to 40%. Effectiveness will be determined by the change
      in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the
      severity of anemia), transfusion requirements, and the patient's quality of life assessment.
      Safety assessments include the incidence and severity of adverse events during the study,
      results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements
      of vital signs, electrocardiograms (ECGs) and physical examination findings. The study
      hypothesis is that for treatment of anemia in patients with AIDS who are receiving AZT
      therapy, epoetin alfa is superior to placebo, as measured by changes in hemoglobin,
      hematocrit, and reticulocyte count, transfusion requirements, and the patient's quality of
      life.

      Double-blind period: epoetin alfa (100 units per kilogram [U/kg] of body weight) or placebo,
      injected intravenously three times a week for 12 weeks. Open-label period: epoetin alfa
      injected under the skin for up to 6 months, with dose adjustments in the range of 0 to 1,500
      U/kg as needed to maintain hematocrit levels of 38% to 40%.
    

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: erythropoietin; Anemia; Quality of Life; epoetin alfa; HIV; Zidovudine; AIDS