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Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000587
First received: October 27, 1999
Last updated: January 3, 2006
Last verified: December 2005

October 27, 1999
January 3, 2006
September 1988
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Complete list of historical versions of study NCT00000587 on ClinicalTrials.gov Archive Site
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Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
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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).

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • Anemia
  • Hematologic Diseases
  • HIV Infections
  • Blood Disease
Procedure: erythropoietin, recombinant
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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
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No eligibility criteria

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000587
307
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Stephen Hauptman Jefferson Medical College of Thomas Jefferson University
National Heart, Lung, and Blood Institute (NHLBI)
December 2005

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