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The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Ortho Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002303
  Purpose

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.


Condition Intervention
HIV Infections
Cytopenias
Drug: Epoetin alfa

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 Patients With AIDS or Advanced ARC and Anemia

Resource links provided by NLM:

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

Concurrent Medication:

Excluded:

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

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

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) and during double-blind phase of study.

Clinical diagnosis of AIDS related anemia.

  • Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
  • Clinically stable for 1 month preceding study entry.

Substance abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002303

Locations
United States, New Jersey
Ortho Pharmaceutical Corp
Raritan, New Jersey, United States, 088690602
Sponsors and Collaborators
Ortho Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: 004D, H87-048
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002303     History of Changes
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
Hematinics
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on September 02, 2009