A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

Completed · Not applicable

Conditions studied: HIV Infections, Cytopenias

In brief

To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.

Key facts

Study ID

NCT00002042

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.
• HIV disease related dementia.
• Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
• Presence of concomitant iron deficiency.
• Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
• Acute opportunistic infection.
• History of seizures.
• Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
• Concurrent Medication:
• Excluded:
• Zidovudine (AZT) therapy during the double-blind phase of study.
• 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.
• HIV disease related dementia.
• Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
• Presence of concomitant iron deficiency.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.