Expired Study
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Raritan, New Jersey 08869


Purpose:

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.


Criteria:

Exclusion Criteria 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. - Zidovudine (AZT) therapy and during the double-blind phase. Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia. - Clinical diagnosis of AIDS or ARC. - Clinically stable for 1 month preceding study entry. - Patients should preferably be transfusion dependent. Substance abuse.


NCT ID:

NCT00002042


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Raritan, New Jersey 08869
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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