Cytopenias, HIV Infections
Conditions
Keywords
Recombinant Proteins, Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Brief summary
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.
Interventions
DRUGEpoetin alfa
Sponsors
Ortho Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * Patients who have previously participated in any other r-HuEPO clinical study 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 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.
Countries
United States
Outcome results
None listed