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Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000587
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2021
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
To determine whether administration of human recombinant erythropoietin (REPO) improved or eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after therapy with zidovudine (ZDV).

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome Anemia Hematologic Diseases HIV Infections Blood Disease Procedure: erythropoietin, recombinant Phase 2

Detailed Description:


Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency Syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity, requiring zidovudine dosage alterations, blood transfusions, or cessation of therapy. While zidovudine efficacy had been demonstrated in patients with AIDS or ARC, it was also evaluated in patients with AIDS-related illness, as well as in asymptomatic HIV-infected individuals. The clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the United States.

The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow Suppression in AIDS or AIDS-Related Complex. The concept was approved at the May 1987 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in December 1987.


Double-blind, placebo-controlled. Patients received intravenous REPO (1000 IU/kg) or placebo twice per week. The five patients in Group A had no transfusion history. The five patients in Group B had a history of transfusions. Prior to the study, the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 12.5 g/dl. After the twelve week study period, patients were eligible to receive open label erythropoietin (500 IU/kg, twice a week). For numerous reasons, recruitment of patients was a major problem in this trial. The study originally estimated a total of 64 patients.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Actual Study Start Date : September 1988
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia HIV/AIDS

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00000587

Sponsors and Collaborators
Thomas Jefferson University
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OverallOfficial: Stephen Hauptman Jefferson Medical College of Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT00000587    
Other Study ID Numbers: 307
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Hematologic Diseases
Immunologic Deficiency Syndromes
Communicable Diseases
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immune System Diseases
Slow Virus Diseases
Epoetin Alfa