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A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

This study has been completed.

Sponsored by: Ortho Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002042
  Purpose

To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.


Condition Intervention
HIV Infections
Cytopenias
Drug: Epoetin alfa

MedlinePlus related topics:   AIDS    Anemia   

Drug Information available for:   Zidovudine    Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • History of any primary hematologic disease.
  • HIV disease related dementia.
  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
  • Presence of concomitant iron deficiency.
  • Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
  • Acute opportunistic infection.
  • History of seizures.
  • Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT) therapy during the double-blind phase of study.

Patients with the following are excluded:

  • History of any primary hematologic disease.
  • Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
  • HIV disease related dementia.
  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
  • Presence of concomitant iron deficiency.

Prior Medication:

Excluded within 30 days of study entry:

  • Experimental drug or experimental device.
  • Cytotoxic chemotherapy.
  • Excluded within 2 months of study entry:
  • Androgen therapy.
  • Zidovudine (AZT) therapy and during the double-blind phase.

Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.

  • Clinical diagnosis of AIDS or ARC.
  • Clinically stable for 1 month preceding study entry.
  • Patients should preferably be transfusion dependent.

Substance abuse.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002042

Locations
United States, New Jersey
Ortho Pharmaceutical Corp    
      Raritan, New Jersey, United States, 088690602

Sponsors and Collaborators
Ortho Pharmaceuticals
  More Information


Study ID Numbers:   004F, 87-022
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002042
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins  
Erythropoietin  
Acquired Immunodeficiency Syndrome  
Anemia
AIDS-Related Complex
Zidovudine

Study placed in the following topic categories:
Epoetin Alfa
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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