Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT03478033
Status:
UNKNOWN
Last Update Posted:
2018-04-24
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015658', 'term': 'HIV 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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'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': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participates are assigned to one of two groups in parallel for the duration of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of sputum negative conversion', 'timeFrame': '2~24 weeks', 'description': 'The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.'}, {'measure': 'Case fatality rate', 'timeFrame': '12 months', 'description': 'The number of deaths during follow-up caused by HIV/AIDS and TB / the number of patients with HIV/AIDs and TB enrolled in this study \\* 100%.'}], 'secondaryOutcomes': [{'measure': 'Treatment completion status', 'timeFrame': '12 months', 'description': 'The rate of patients who complete the whole anti-tuberculous treatment.'}, {'measure': 'The percentage of HIV viral load less than the detection limit', 'timeFrame': '6 months and 12 months', 'description': 'The percentage of HIV viral load less than the detection limit'}, {'measure': 'AE', 'timeFrame': '12 months', 'description': 'The number and severity of adverse event.'}, {'measure': 'Time of sputum negative conversion', 'timeFrame': '2~24 weeks', 'description': 'The time of sputum negative conversion.'}, {'measure': 'Chest CT scans improvement', 'timeFrame': '2~24 weeks', 'description': 'Chest CT showed tuberculosis lesion absorption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'AIDS', 'Rifampicin', 'Rifabutin'], 'conditions': ['Tuberculosis, Pulmonary', 'AIDS']}, 'descriptionModule': {'briefSummary': 'To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.', 'detailedDescription': 'Two hundreds and thirty participants will be randomly assigned to receive an anti--tuberculosis treatment include rifampicin or rifabutin for two months of intensive therapy. Isoniazid and rifampicin (or rifabutin) will be continued to use for four months of consolidation therapy. A total of followed up period will be 12 months.\n\nThe antiretroviral therapy（ART） include:\n\nTenofovir disoproxil fumarate 300mg/d +Lamivudine 300mg/d+ Efavirenz 600mg/d; or Zidovudine 300mg bid +Lamivudine 300mg/d +Efavirenz 600mg/d.\n\nART will be started after 2 weeks of anti-tuberculosis.\n\nThe follow-up visits include 2th, 4th, 6th, 8th, 12th,16th, 20th, 24th, 32th, 36th, 40th, 44th and 48th week. sputum smear, sputum culture, chest X-ray, CD4 Lymphocyte counts,HIV viral load and adverse event will be tested and recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-65 years old;\n2. No limited to gender;\n3. If anti-HIV-1 positive samples are detected by an initial test based on the ELISA method, they should be confirmed by western blot;\n4. The patients who are diagnosed with pulmonary TB (mycobacterium tuberculosis of sputum smear or culture was positive) but had never be treated;\n5. Sign informed consent form voluntarily, and guarantee to attend follow-up visits;\n6. Do not have plan to remove from the current experimental site during the trial process;\n7. The patients do not receive any antiretroviral treatment before;\n8. The overall situation of the patient should not affect the assessment and completion of the trial.\n\nExclusion Criteria:\n\n1. Patients with acute infection;\n2. During the screening period，patients with combined opportunistic infections and instability (National HIV/AIDS treatment guidelines) except for tuberculosis, or combined malignancy;\n3. During the screening period，hemachrome \\< 6 g/dl, leukocyte \\< 2000 /µl, neutrophils \\< 1000 /µl, platelet count \\< 75000 /µl, blood amylase is greater than two times the upper limit of normal, Scr is greater than1.5 times the upper limit of normal, AST/ALT/AKP is greater than two times the upper limit of normal, TBIL is greater than two times the upper limit of normal, serum CK is greater than two times the upper limit of normal;\n4. Now suffering from acute or chronic pancreatitis;\n5. Now suffering from peripheral neuritis;\n6. Pregnant and lactating women;\n7. Patients with severe mental and neurological diseases;\n8. Drug users；\n9. Patients with history of heavy drinking and cannot be terminated;\n10. Serious gastrointestinal ulcers；\n11. Atherosclerosis affects the arteries in the heart, brain or kidneys；\n12. Non-Chinese nationality；\n13. Now suffering from myopathy；\n14. Patients with previously treated tuberculosis.'}, 'identificationModule': {'nctId': 'NCT03478033', 'acronym': 'RRHT', 'briefTitle': 'Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Public Health Clinical Center'}, 'officialTitle': 'The Efficacy and Safety Evaluation of Standardized Treatment Included Rifampicin or Rifabutin in HIV/AIDs Patients Combined With Pulmonary Tuberculosis. A Prospective Study.', 'orgStudyIdInfo': {'id': '2017ZX10202101-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rifampicin group', 'description': 'Rifampicin group: Intensive treatment（4 types of anti-TB medicines）for 2 months, then isoniazid and rifampicin for 4 months of consolidation therapy.\n\nisoniazid: 10-15mg/kg rifampicin: 10-20mg/kg pyrazinamide: 30-40mg/kg thambutol: 0.75(W\\<50kg)；1.0 g/d（W≥50kg）', 'interventionNames': ['Drug: Rifampicin']}, {'type': 'EXPERIMENTAL', 'label': 'Rifabutin group', 'description': 'Rifabutin group: Intensive treatment（4 types anti-TB medicines）for 2 months,then isoniazid and rifabutin for 4 months of consolidation therapy.\n\nisoniazid: 10-15mg/kg rifabutin: 0.45g/d(W\\<50kg); 0.6g/d( W≥50kg） pyrazinamide: 30-40mg/kg thambutol: 0.75(W\\<50kg)；1.0 g/d（W≥50kg）', 'interventionNames': ['Drug: Rifabutin']}], 'interventions': [{'name': 'Rifampicin', 'type': 'DRUG', 'otherNames': ['Rifampicin/INH/EMB/PZA'], 'description': 'Rifampicin capsules, 150mg', 'armGroupLabels': ['Rifampicin group']}, {'name': 'Rifabutin', 'type': 'DRUG', 'otherNames': ['Rifabutin/INH/EMB/PZA'], 'description': 'Rifabutin capsules, 150mg', 'armGroupLabels': ['Rifabutin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201508', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingzhong Shen, PhD，MD', 'role': 'CONTACT', 'email': '027465@163.com', 'phone': '86-021-37990333', 'phoneExt': '3222'}], 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongzhou Lu, PhD，MD', 'role': 'CONTACT', 'email': 'luhongzhou@fudan.edu.cn', 'phone': '86-021-37990333', 'phoneExt': '3222'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Guangxi Zhuang Autonomous Region Longtan hospital', 'class': 'UNKNOWN'}, {'name': "The Fourth People's Hospital of Nanning", 'class': 'OTHER'}, {'name': "Shenzhen Third People's Hospital", 'class': 'OTHER'}, {'name': 'Yunnan Provincial Infectious Disease Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Chongqing Public Health Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director', 'investigatorFullName': 'Hongzhou Lu', 'investigatorAffiliation': 'Shanghai Public Health Clinical Center'}}}}