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A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused by the Disease and by Zidovudine (AZT) Therapy

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00270270
First received: December 22, 2005
Last updated: May 17, 2011
Last verified: April 2010

December 22, 2005
May 17, 2011
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Change in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the severity of anemia); Transfusion requirements; Safety evaluations including adverse events
Same as current
Complete list of historical versions of study NCT00270270 on ClinicalTrials.gov Archive Site
Patient's quality of life assessment
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused by the Disease and by Zidovudine (AZT) Therapy
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

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo in AIDS patients for the treatment of anemia that is a result of the disease or a result of zidovudine (AZT) treatment for AIDS. 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 study with an open-label follow-up period that is designed to evaluate the safety and effectiveness of epoetin alfa treatment compared with placebo treatment in patients with AIDS who are being treated with AZT. The study consists of three periods: a screening period to determine if patients are eligible for the study, a double-blind period, and an open-label period. During the double-blind period, patients are randomly assigned to one of two groups and receive either epoetin alfa (100 units per kilogram) or placebo injected into a vein (intravenously) three 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 (subcutaneously) for up to 6 months at the dose needed to maintain hematocrit levels of 38% to 40%. Effectiveness will be determined by the change in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and the patient's quality of life assessment. Safety assessments include the incidence and severity of adverse events during the study, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements of vital signs, electrocardiograms (ECGs) and physical examination findings. The study hypothesis is that for treatment of anemia in patients with AIDS who are receiving AZT therapy, epoetin alfa is superior to placebo, as measured by changes in hemoglobin, hematocrit, and reticulocyte count, transfusion requirements, and the patient's quality of life.

Double-blind period: epoetin alfa (100 units per kilogram [U/kg] of body weight) or placebo, injected intravenously three times a week for 12 weeks. Open-label period: epoetin alfa injected under the skin for up to 6 months, with dose adjustments in the range of 0 to 1,500 U/kg as needed to maintain hematocrit levels of 38% to 40%.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • Anemia
Drug: epoetin alfa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
July 1989
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Inclusion Criteria: - Patients with a confirmed diagnosis of AIDS, with a hematocrit <=30% - preferably dependent on transfusions - having a history of at least a 15% decrease in hematocrit since the beginning of AZT therapy, or have become dependent on transfusions - who are clinically stable for at least 1 month before study entry - females must be at least 1 year post-menopausal, surgically sterile, or practicing an effective method of birth control, and have a negative pregnancy test before study entry.

Exclusion Criteria: - Patients with a history of any primary 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 uncontrolled high blood pressure - having anemia caused by conditions other than AIDS (for example, vitamin deficiency or bleeding from the gastrointestinal tract) - having a serum ferritin value <30 ng/mL or an iron/total iron-binding capacity (Fe/TIBC) ratio less than 15%.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00270270
CR006070
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Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP