Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00002267
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
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': '1992-03', '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 objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.'}, '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 obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.\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': 'NCT00002267', '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': '048B'}, 'secondaryIdInfos': [{'id': '087027-999'}]}, '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': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Med Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'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': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr Larry A Waites', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Saint Francis Mem Hosp / HIV Care', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr Marcus Conant', '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': '95404', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Dr Marshall Kubota', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Dr Jeffrey Galpin', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Research Initiative of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ Med School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'AIDS Research Alliance - Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive AIDS Alliance of Detroit / Harper Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Univ of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St Paul Ramsey Med Ctr', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '89520', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Univ of Nevada / Veterans Administration Med Ctr', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '071032842', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Community Research Initiative', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Univ of New Mexico Hlth Sciences Ctr / Dept of Med', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87501', 'city': 'Sante Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Dr Donald Romig'}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Veterans Administration', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'AIDS Services Erie County Med Ctr', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Community Health Network', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Buckley Braffman Stern Med Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Med College', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'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}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Univ of Calgary Health Science Ctr', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Univ of Alberta/Division of Inf Dis/Dept of Med', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Saint Paul's Hosp", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Victoria Gen Hosp', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster Univ Med Ctr', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Gen Hosp', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hosp', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Michael's Hosp", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Ctr', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr Emil Toma / Hotel Dieu de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Chest Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Gen Hosp', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacia', 'class': 'INDUSTRY'}}}}