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

Ortho Pharmaceuticals

Status: Completed

Conditions: Cytopenias; HIV Infections

Treatments: Drug: Epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002042

87-022

004F

Details and patient eligibility

About

To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.