A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in Patients With Acquired Immunodeficiency Syndrome (AIDS) Who Are Receiving 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 in AIDS
      patients for the treatment of anemia that is a result of the 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,
      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, 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
      treatment period, and an open-label treatment period. Eligible patients will be randomly
      assigned to one of two groups: epoetin alfa 150 units per kilogram or matching placebo.
      Patients will be treated with study medication (injected under the skin) 3 times a 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 and hematocrit (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, 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, 150 units per kilogram [U/kg] of body weight, or placebo,
      injected under the patient's skin 3 times a week for 12 weeks or until the hematocrit level
      reaches 38% to 40%. Open-label: epoetin alfa, 200 U/kg, 3 times a week for up to 6 months
      (once weekly after hematocrit reaches 38% to 40%). Dose may be adjusted up to 1500 U/kg per
      week, as needed.
    

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; erythropoietin; epoetin alfa; Quality of Life; Zidovudine; HIV