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

Ortho Pharmaceuticals

Status: Completed

Conditions: Cytopenias; HIV Infections

Treatments: Drug: Epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002073

I88-009

004E

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.