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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Pharmaceuticals
• Treatments: Epoetin Alfa

Criteria

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 and related anemia.

• Clinical diagnosis of AIDS.

• Clinically stable for 1 month preceding study entry.

Substance abuse.