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

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

Summary

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.

• 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.

• 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.