Anemia Clinical Trial
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
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | April 1990 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with a confirmed diagnosis of AIDS - having a Performance
score of 0, 1, or 2 (patients' ability to perform daily activities, a score ranging from 0
[fully active, no disease restriction] to 3 [capable of only limited self-care, confined
to bed or chair more than 50% of waking hours]) - taking a maintenance dose of AZT of at
least 400 mg/day - having a hematocrit of at least 30% and a history of a >=15% decrease
in hematocrit since starting AZT therapy, or have become dependent on transfusions - who
are clinically stable for at least 1 month before study entry. Exclusion Criteria: - Patients having a history of any important blood disease - having any clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which is not caused by the AIDS infection - having dementia due to AIDS, a history of seizures, uncontrolled high blood pressure, or an iron deficiency - 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 sudden onset of infections, or a history of cell damage due to chemotherapy within 1 month before study entry. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in hemoglobin and hematocrit (laboratory tests used to evaluate the severity of anemia); Transfusion requirements; Patient's quality of life assessment | |||
Secondary | Adverse events; changes in clinical laboratory tests, vital signs, electrocardiograms, and physical examination findings; Physician's global evaluation of the overall effect of the drug |
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