Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT00000587
Collaborator
(none)
196

Study Details

Study Description

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
  • Procedure: erythropoietin, recombinant
Phase 2

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Actual Study Start Date :
Sep 1, 1988
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    No eligibility criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    • : Stephen Hauptman, Jefferson Medical College of Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT00000587
    Other Study ID Numbers:
    • 307
    First Posted:
    Oct 28, 1999
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021

    Study Results

    No Results Posted as of Nov 26, 2021