To determine the safety and efficacy of erythropoietin administered to patients with AIDS or
advanced AIDS related complex ARC and anemia.
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.
- 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.
- Zidovudine (AZT) during the double-blind phase of the study.
Patients with clinically significant disease / dysfunction of the pulmonary,
cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not
attributable to underlying AIDS 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.
- Zidovudine (AZT) and during double-blind phase of study.
Clinical diagnosis of AIDS related anemia.
- Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
- Clinically stable for 1 month preceding study entry.