A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy|
- Change in hemoglobin, hematocrit, and reticulocytes (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.
- 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
|Study Completion Date:||January 1989|
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, 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 100 U/kg or a group receiving 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, hematocrit, and reticulocytes (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 (100 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 150 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.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|