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.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989
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.
Drug: Epoetin alfa
Primary Purpose: Treatment
||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:
|Accepts Healthy Volunteers:
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.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002302
|AIDS Research Consortium of Atlanta
|Atlanta, Georgia, United States, 30308 |
|Ortho Pharmaceutical Corp
|Raritan, New Jersey, United States, 088690602 |
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)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 28, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases