Expired Study
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Raritan, New Jersey 08869


Purpose:

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Maintenance dose of zidovudine (AZT) of at least 400 mg daily. 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. - Must not have previously participated in any other r-HuEPO clinical studies. 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. - Maintenance dose of zidovudine (AZT) of at least 400 mg daily. Substance abuse.


NCT ID:

NCT00002073


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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