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

Completed · Not applicable

Conditions studied: HIV Infections, Cytopenias

In brief

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.

Key facts

Study ID: NCT00002072
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 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.

Where it is running

Ortho Pharmaceutical Corp — Raritan, New Jersey, United States

Full record on ClinicalTrials.gov

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