A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
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 (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.
Clinical Details
Official title:
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy 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.
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 and related anemia.
- Clinical diagnosis of AIDS.
- Clinically stable for 1 month preceding study entry.
Substance abuse.
Locations and Contacts
Ortho Pharmaceutical Corp, Raritan, New Jersey 088690602, United States
Additional Information
Last updated: June 23, 2005
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