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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002302 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT
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

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.

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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Cytopenias
Drug: Epoetin alfa
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002302
004B, 87-021
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Ortho Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
December 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP