The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Cytopenias
Intervention: Epoetin alfa (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ortho Pharmaceuticals
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.
Clinical Details
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
Study design: Interventional, Treatment, Double-Blind
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
Ortho Pharmaceutical Corp, Raritan, New Jersey 088690602, United States
Additional Information
Related 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)
Last updated: June 23, 2005
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