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

Inclusion Criteria Concurrent Medication: Allowed: Maintenance dose of zidovudine (AZT) of at least 400 mg daily. 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.