Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00002302
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Recombinant Proteins', 'Injections, Subcutaneous', 'Erythropoietin', 'Acquired Immunodeficiency Syndrome', 'Anemia', 'Zidovudine'], 'conditions': ['HIV Infections', 'Cytopenias']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Rarick M, Wilson E, Bernstein-Singer M, Gill PS, Muggia F, Levine AM. Double-blind placebo controlled study of recombinant human erythropoietin in AIDS patients with anemia caused by HIV infection and zidovudine. Int Conf AIDS. 1989 Jun 4-9;5:195 (abstract no MBO48)'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* History of any primary hematologic disease.\n* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.\n* AIDS-related dementia.\n* Uncontrolled hypertension (diastolic blood pressure \\> 100 mmHg).\n* Presence of concomitant iron deficiency.\n* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.\n* Acute opportunistic infection.\n* History of seizures.\n\nPatients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.\n\n* Patients who have previously participated in any other r-HuEPO clinical study are excluded.\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Experimental drug or experimental device.\n* Cytotoxic chemotherapy.\n* Excluded within 2 months of study entry:\n* Androgen therapy.\n\nClinical diagnosis of AIDS related anemia.\n\n* Clinical diagnosis of AIDS.\n* Clinically stable for 1 month preceding study entry.\n* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.\n\nSubstance abuse.'}, 'identificationModule': {'nctId': 'NCT00002302', 'briefTitle': 'The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '004B'}, 'secondaryIdInfos': [{'id': '87-021'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Epoetin alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '088690602', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Ortho Pharmaceutical Corp', 'geoPoint': {'lat': 40.56955, 'lon': -74.63294}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ortho Pharmaceuticals', 'class': 'INDUSTRY'}}}}