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
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ortho Pharmaceutical Corp | Raritan | New Jersey | United States | 088690602 |
Sponsors and Collaborators
- Ortho Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 004C
- H87-037