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The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002302
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989
History of Changes
  Purpose

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Condition Intervention
HIV Infections
Cytopenias
 Drug: Epoetin alfa

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Resource links provided by NLM:

MedlinePlus related topics: Anemia HIV/AIDS
U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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 AIDS.
  • 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.

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

  • Patients who have previously participated in any other r-HuEPO clinical study 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.

Clinical diagnosis of AIDS related anemia.

  • Clinical diagnosis of AIDS.
  • Clinically stable for 1 month preceding study entry.
  • Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002302

Locations
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, New Jersey
Ortho Pharmaceutical Corp
Raritan, New Jersey, United States, 088690602
Sponsors and Collaborators
Ortho Pharmaceuticals
  More Information

Publications:
Rarick M, Wilson E, Bernstein-Singer M, Gill PS, Muggia F, Levine AM. Double-blind placebo controlled study of recombinant human erythropoietin in AIDS patients with anemia caused by HIV infection and zidovudine. Int Conf AIDS. 1989 Jun 4-9;5:195 (abstract no MBO48)

ClinicalTrials.gov Identifier: NCT00002302     History of Changes
Other Study ID Numbers: 004B, 87-021
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins
Injections, Subcutaneous
Erythropoietin
 Acquired Immunodeficiency Syndrome
Anemia
Zidovudine

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

ClinicalTrials.gov processed this record on May 16, 2013