HIV Infections Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
NCT number | NCT00002073 |
Other study ID # | 004E |
Secondary ID | I88-009 |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ortho Pharmaceutical Corp | Raritan | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Ortho Pharmaceuticals |
United States,
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