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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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