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
  Purpose

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-Blind
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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000587

Sponsors and Collaborators
Investigators
Investigator: Stephen Hauptman Jefferson Medical College of Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000587     History of Changes
Other Study ID Numbers: 307
Study First Received: October 27, 1999
Last Updated: January 3, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Anemia
Hematologic Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014