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Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: October 27, 1999
Last updated: January 3, 2006
Last verified: December 2005
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 Intervention Phase
Acquired Immunodeficiency Syndrome Anemia Hematologic Diseases HIV Infections Blood Disease Procedure: erythropoietin, recombinant Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1988
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria
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Please refer to this study by its identifier: NCT00000587

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Stephen Hauptman Jefferson Medical College of Thomas Jefferson University
  More Information Identifier: NCT00000587     History of Changes
Other Study ID Numbers: 307
Study First Received: October 27, 1999
Last Updated: January 3, 2006

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Hematologic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Epoetin Alfa
Hematinics processed this record on September 25, 2017