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

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.
• •Must not have previously participated in any other r-HuEPO clinical studies.
• •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.
• •Maintenance dose of zidovudine (AZT) of at least 400 mg daily.
• •Substance abuse.