- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002303
The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in Patients With AIDS or Advanced ARC and Anemia
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Raritan, New Jersey, United States, 088690602
- Ortho Pharmaceutical Corp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 HIV disease.
- 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.
Concurrent Medication:
Excluded:
- Zidovudine (AZT) during the double-blind phase of the study.
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.
- Zidovudine (AZT) and during double-blind phase of study.
Clinical diagnosis of AIDS related anemia.
- Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
- Clinically stable for 1 month preceding study entry.
Substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- AIDS-Related Complex
- Hematinics
- Epoetin Alfa
Other Study ID Numbers
- 004D
- H87-048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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