To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- History of any primary hematologic disease.
- HIV disease related dementia.
- Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
- Presence of concomitant iron deficiency.
- Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
- Acute opportunistic infection.
- History of seizures.
- Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
Concurrent Medication:
Excluded:
- Zidovudine (AZT) therapy during the double-blind phase of study.
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 HIV disease.
- HIV disease related dementia.
- Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
- Presence of concomitant iron deficiency.
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.
- Zidovudine (AZT) therapy and during the double-blind phase.
Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.
- Clinical diagnosis of AIDS or ARC.
- Clinically stable for 1 month preceding study entry.
- Patients should preferably be transfusion dependent.
Substance abuse.
