The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic

Completed · Not applicable

Conditions studied: HIV Infections, Cytopenias

In brief

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.

Key facts

Study ID

NCT00002303

Run by

Ortho Pharmaceuticals

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Ortho Pharmaceutical Corp — Raritan, New Jersey, United States

Full record on ClinicalTrials.gov

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