Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 11:17 AM
Study NCT ID:
NCT00001995
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015270', 'term': 'Mycobacterium avium-intracellulare Infection'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017828', 'term': 'Rifabutin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1992-11', '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': ['Rifabutin', 'Mycobacterium avium-intracellulare Infection', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Mycobacterium Avium-Intracellulare Infection', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '8807071', 'type': 'BACKGROUND', 'citation': 'Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.'}]}, 'descriptionModule': {'briefSummary': 'To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT).\n* Didanosine (ddI).\n\nPatients must have the following:\n\n* Diagnosis of AIDS as defined by the CDC.\n* Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).\n* Provide written informed consent.\n\nPrior Medication:\n\nAllowed:\n\n* If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.\n* Required:\n* Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Known hypersensitivity to any of the study drugs.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other therapy for mycobacterial disease.\n\nPatients with the following are excluded:\n\n* Known hypersensitivity to any of the study drugs.\n\nPrior Medication:\n\nExcluded within 4 weeks:\n\n* Therapy for mycobacterial disease.\n* Antiretroviral drugs, other than zidovudine (AZT) or ddI.\n* Investigational drugs, other than ddI.'}, 'identificationModule': {'nctId': 'NCT00001995', 'briefTitle': 'A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS', 'orgStudyIdInfo': {'id': '048C'}, 'secondaryIdInfos': [{'id': 'CS 087065'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Rifabutin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85010', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa County Med Ctr', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90710', 'city': 'Harbor City', 'state': 'California', 'country': 'United States', 'facility': 'Bay Harbor Hosp', 'geoPoint': {'lat': 33.79002, 'lon': -118.29785}}, {'zip': '92718', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Community Based AIDS Treatment Group - COMBAT', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Community Research Consortium', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'HIV Research Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Administration Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Veterans Administration Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'TheraFirst Med Ctrs Inc', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Mem Hosp Hollywood', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30076', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Infectious Disease Research Consortium of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Dr Frank Rhame', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Med Ctr', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '071032842', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Community Research Initiative', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11554', 'city': 'East Meadow', 'state': 'New York', 'country': 'United States', 'facility': 'Nassau County Med Ctr', 'geoPoint': {'lat': 40.71399, 'lon': -73.55902}}, {'zip': '10014', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Chelsea Village Med Ctr / Saint Vincent's Hosp", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dr Alfred F Burnside Jr', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '22203', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Disease Physicians Inc', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee County Med Complex', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacia', 'class': 'INDUSTRY'}}}}