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A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease

Primary Purpose

Anemia, Acquired Immunodeficiency Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, AIDS, HIV, Zidovudine, Quality of Life, erythropoietin, epoetin alfa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a confirmed diagnosis of AIDS, exhibiting signs and symptoms of AIDS characterized by lymphocytopenia (decrease in the number of lymphocytes [cells that are typical elements of lymph tissue] in the blood) as determined by a finding of <1,000 cells/cubic millimeter having a documented HIV antibody (either a history of infections due to the patient's impaired resistance or the presence of severe symptoms, such as persistent fever or night sweats associated with significant weight loss) receiving AZT therapy of at least 400 mg/day having a hematocrit <=30%, and a history of a >=15% decrease in hematocrit since starting AZT therapy, or that the patient has become dependent on transfusions clinically stable for at least 1 month before study entry, with a performance score of 0, 1, or 2. Exclusion Criteria: Patients with a history of any important blood disease or clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which are not caused by the AIDS infection having a sudden onset of infections, dementia due to AIDS, uncontrolled high blood pressure, or an iron deficiency received androgen therapy within 2 months of study entry having anemia caused by other conditions than AIDS or AZT therapy (for example, certain vitamin deficiencies or bleeding from the gastrointestinal tract) having a history of seizures, history of cell damage due to chemotherapy within 1 month before study entry, or a history of substance abuse.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in hemoglobin and hematocrit (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.

    Secondary Outcome Measures

    Adverse events; changes in clinical laboratory tests, vital sign measurements, ECGs, and physical examination findings; and physician's global evaluation of the overall effect of the drug

    Full Information

    First Posted
    December 22, 2005
    Last Updated
    May 17, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00270010
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease
    Official Title
    A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1989 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief 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 (neither the patient nor the physician knows whether the patient is receiving epoetin alfa or placebo), 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 200 U/kg or a group receiving a 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 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, 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 (200 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 250 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Acquired Immunodeficiency Syndrome
    Keywords
    Anemia, AIDS, HIV, Zidovudine, Quality of Life, erythropoietin, epoetin alfa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    epoetin alfa
    Primary Outcome Measure Information:
    Title
    Change in hemoglobin and hematocrit (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.
    Secondary Outcome Measure Information:
    Title
    Adverse events; changes in clinical laboratory tests, vital sign measurements, ECGs, and physical examination findings; and physician's global evaluation of the overall effect of the drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a confirmed diagnosis of AIDS, exhibiting signs and symptoms of AIDS characterized by lymphocytopenia (decrease in the number of lymphocytes [cells that are typical elements of lymph tissue] in the blood) as determined by a finding of <1,000 cells/cubic millimeter having a documented HIV antibody (either a history of infections due to the patient's impaired resistance or the presence of severe symptoms, such as persistent fever or night sweats associated with significant weight loss) receiving AZT therapy of at least 400 mg/day having a hematocrit <=30%, and a history of a >=15% decrease in hematocrit since starting AZT therapy, or that the patient has become dependent on transfusions clinically stable for at least 1 month before study entry, with a performance score of 0, 1, or 2. Exclusion Criteria: Patients with a history of any important blood disease or clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which are not caused by the AIDS infection having a sudden onset of infections, dementia due to AIDS, uncontrolled high blood pressure, or an iron deficiency received androgen therapy within 2 months of study entry having anemia caused by other conditions than AIDS or AZT therapy (for example, certain vitamin deficiencies or bleeding from the gastrointestinal tract) having a history of seizures, history of cell damage due to chemotherapy within 1 month before study entry, or a history of substance abuse.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=673&filename=CR005842_CSR.pdf
    Description
    A study to evaluate the safety and effectiveness of epoetin alfa in AIDS (acquired immunodeficiency syndrome) patients with anemia caused both by their disease and by AZT (zidovudine, an antiviral drug) given as treatment for their disease

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    A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease

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