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.