Overview

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.