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

Launched by ORTHO PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.