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.