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

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

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.

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.