Overview

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.