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

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 related anemia. * Clinical diagnosis of AIDS. * Clinically stable for 1 month preceding study entry. Substance abuse.