A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

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.