Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 6:58 AM
Study NCT ID:
NCT00002032
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
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': 'D017088', 'term': 'AIDS-Related Opportunistic 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': 'D009894', 'term': 'Opportunistic Infections'}, {'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': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1992-01', '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', 'AIDS-Related Opportunistic Infections', 'Mycobacterium avium-intracellulare Infection', 'Acquired Immunodeficiency Syndrome', 'Antitubercular Agents'], '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.'}, {'pmid': '8605053', 'type': 'BACKGROUND', 'citation': 'Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. doi: 10.1097/00002030-199512000-00006.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have the following:\n\n* Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).\n* Written informed consent.\n* Females of childbearing potential must also sign a special informed consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).\n* Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretroviral agents other than zidovudine (AZT).\n* Didanosine (ddI).\n* Antimycobacterial therapy.\n* Rifampin.\n* Isoniazid.\n* Clofazimine.\n* Ethambutol.\n* Cycloserine.\n* Ethionamide.\n* Amikacin.\n* Ciprofloxacin.\n* Streptomycin.\n* Other investigational drugs.\n* If antimicrobial therapy is required to treat bacterial infections (= or \\< 14 days), Adria Laboratories must be contacted prior to initiation of therapy.\n\nPatients with the following are excluded:\n\n* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).\n* Previous or current Mycobacterium avium complex (MAC) infection.\n* Perceived patient unreliability or unavailability for frequent monitoring.\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).\n* Antimycobacterial therapy.\n* Rifampin.\n* Isoniazid.\n* Clofazimine.\n* Ethambutol.\n* Cycloserine.\n* Ethionamide.\n* Amikacin.\n* Ciprofloxacin.\n\nRequired:\n\n* Zidovudine (AZT).\n* Antipneumocystis prophylactic therapy.\n\nRequired for at least 4 weeks prior to study entry:\n\n* Zidovudine (AZT) or didanosine (ddI).\n* Antipneumocystis prophylaxis.'}, 'identificationModule': {'nctId': 'NCT00002032', 'briefTitle': 'Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '048A'}, 'secondaryIdInfos': [{'id': '087023-999'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Rifabutin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92718', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Ctr for Special Immunology', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View Med Ctr', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health Dept', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'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': 'Ctr for Special Immunology', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'TheraFirst Med Ctrs Inc', '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': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'VP Med Services / HHCS Research Institute Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30335', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hosp / Hughs Spalding Med Ctr', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr Winkler Weinberg', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Univ of Missouri at Kansas City School of Medicine', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Med Ctr', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11209', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Veterans Administration', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Med Ctr', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11554', 'city': 'East Meadow', 'state': 'New York', 'country': 'United States', 'facility': 'Nassau County Med Ctr', 'geoPoint': {'lat': 40.71399, 'lon': -73.55902}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Med Ctr', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Community Research Initiative', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10014', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Chelsea Village Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mem Sloan - Kettering Cancer Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ Hosp of Cleveland / Case Western Reserve Univ', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Med Ctr', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78751', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Med Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nelson Tebedo Community Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Southwestern Med Ctr of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech Health Sciences Ctr', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77266', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Clinical Research Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78284', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX San Antonio Health Science Ctr', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott and White Hosp', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '76708', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr Scott Lea', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacia', 'class': 'INDUSTRY'}}}}