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Sponsored by: |
Ortho Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002073 |
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 |
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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 Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
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:
Clinical diagnosis of AIDS and related anemia.
Substance abuse.
Study ID Numbers: | 004E, I88-009 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002073 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Recombinant Proteins Injections, Subcutaneous Erythropoietin |
Acquired Immunodeficiency Syndrome Anemia Zidovudine |
Epoetin Alfa Virus Diseases Sexually Transmitted Diseases, Viral Hematinics HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Anemia Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Epoetin Alfa RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Hematinics Hematologic Agents Acquired Immunodeficiency Syndrome Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |