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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

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ClinicalTrials.gov Identifier: NCT00270270
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 18, 2011
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome Anemia Drug: epoetin alfa Phase 2

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, 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%.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Completion Date : July 1989

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Change in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the severity of anemia); Transfusion requirements; Safety evaluations including adverse events

Secondary Outcome Measures :
  1. Patient's quality of life assessment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270270

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech, Inc.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00270270     History of Changes
Obsolete Identifiers: NCT00547313
Other Study ID Numbers: CR006070
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Quality of Life
epoetin alfa

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Pathologic Processes
Hematologic Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Epoetin Alfa
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents