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

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ClinicalTrials.gov Identifier: NCT00002302
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Cytopenias Drug: Epoetin alfa Not Applicable

Study Type : Interventional  (Clinical Trial)
Masking: Double
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 the National Library of Medicine

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





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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1989

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

Additional relevant MeSH terms:
Anemia
HIV Infections
Hematologic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Epoetin Alfa
Hematinics