Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT00351702
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2006-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preventive Therapy for Tuberculosis in HIV Infected Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': '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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D004977', 'term': 'Ethambutol'}], 'ancestors': [{'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 683}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2006-07-12', 'studyFirstSubmitQcDate': '2006-07-12', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure is the development of tuberculosis.', 'timeFrame': 'September 2008'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures include adverse drug reactions and mortality rate.', 'timeFrame': 'September 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preventive therapy'], 'conditions': ['Human Immunodeficiency Virus', 'Tuberculosis']}, 'referencesModule': {'availIpds': [{'url': 'http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0047400', 'type': 'published manuscript', 'comment': 'the study has been published and has been provided in the citation. the paper conatins the required information regarding study results and conclusion'}], 'references': [{'pmid': '10197379', 'type': 'BACKGROUND', 'citation': 'Bucher HC, Griffith LE, Guyatt GH, Sudre P, Naef M, Sendi P, Battegay M. Isoniazid prophylaxis for tuberculosis in HIV infection: a meta-analysis of randomized controlled trials. AIDS. 1999 Mar 11;13(4):501-7. doi: 10.1097/00002030-199903110-00009.'}, {'pmid': '9727988', 'type': 'BACKGROUND', 'citation': 'Wilkinson D, Squire SB, Garner P. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials. BMJ. 1998 Sep 5;317(7159):625-9. doi: 10.1136/bmj.317.7159.625.'}, {'pmid': '9189212', 'type': 'BACKGROUND', 'citation': "Hawken MP, Meme HK, Elliott LC, Chakaya JM, Morris JS, Githui WA, Juma ES, Odhiambo JA, Thiong'o LN, Kimari JN, Ngugi EN, Bwayo JJ, Gilks CF, Plummer FA, Porter JD, Nunn PP, McAdam KP. Isoniazid preventive therapy for tuberculosis in HIV-1-infected adults: results of a randomized controlled trial. AIDS. 1997 Jun;11(7):875-82. doi: 10.1097/00002030-199707000-00006."}, {'pmid': '9295239', 'type': 'BACKGROUND', 'citation': 'Whalen CC, Johnson JL, Okwera A, Hom DL, Huebner R, Mugyenyi P, Mugerwa RD, Ellner JJ. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med. 1997 Sep 18;337(12):801-8. doi: 10.1056/NEJM199709183371201.'}, {'pmid': '10732934', 'type': 'BACKGROUND', 'citation': "Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445."}, {'pmid': '23251327', 'type': 'RESULT', 'citation': 'Swaminathan S, Menon PA, Gopalan N, Perumal V, Santhanakrishnan RK, Ramachandran R, Chinnaiyan P, Iliayas S, Chandrasekaran P, Navaneethapandian PD, Elangovan T, Pho MT, Wares F, Paranji Ramaiyengar N. Efficacy of a six-month versus a 36-month regimen for prevention of tuberculosis in HIV-infected persons in India: a randomized clinical trial. PLoS One. 2012;7(12):e47400. doi: 10.1371/journal.pone.0047400. Epub 2012 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons\n\nPhase: Phase III trial\n\nPopulation: 650 HIV positive patients without tuberculosis\n\nNumber of sites: Three\n\n1. Tuberculosis Research centre, Chennai\n2. Government General Hospital, Chennai\n3. Government Rajaji Hospital, Madurai\n\nStudy Duration: 36 months\n\nStudy Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons\n\nStudy Design:\n\nThe study will be a two-armed prospective randomized clinical trial among HIV- positive patients without active tuberculosis. Enrolled patients will be assigned to one of the two unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3 years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be compared in each group.\n\nStudy Endpoints:The primary end point of the study will be development of tuberculosis and the secondary endpoints will include adverse drug reactions and mortality rate.', 'detailedDescription': 'Study population and enrollment:\n\nAll HIV positive patients seeking care at one of the study centers, above the age of 15 years, not suffering from a serious illness, non-pregnant, and in whom TB was ruled out using the enhanced screening process, will be enrolled in the study. The consent form for prophylaxis trial will be read to the patients in the local language and written consent will be obtained from willing patients\n\nRandomization and Dosing:\n\nAll patients enrolled in the prevention trial will be randomized to one of the study groups using a permuted block randomization scheme of four. Stratification will be done by Mantoux reading (\\>5mm and ≤5mm). The group assignment list will be generated centrally before the start of trial and sequentially numbered sealed envelopes containing the study group assigned will be prepared independently. At the initiation of prophylaxis, each patient will be counseled about the importance of taking drugs regularly. Patients will be asked to return the empty packets as well as unused tablets at each monthly visit.\n\nThe treatment regimens in each study group will be as follows:\n\n1. Ethambutol (800 mg) and Isoniazid (300 mg) daily for six months, self-administered, collected once in fifteen days.\n2. Isoniazid (300 mg) daily for 3 years with fortnightly collection of drugs Subjects in both study groups will receive 10 mg of Pyridoxine daily during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 15 years\n2. HIV positivity (on 2 different ELISA tests on the same blood sample)\n3. Living in Chennai or Madurai within a defined area of intake - 25 km radius.\n4. Likely to remain in the same area for at least three years after start of treatment\n5. The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years\n6. Is agreeable for home visits\n7. No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.\n8. No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.\n9. Patients who fulfill laboratory criteria (hemoglobin \\> 7.0g/l,granulocyte count\\>11,000/l, platelet count \\> 1 lakh/l. serum alanine amino transferase concentration \\< 2.5 times the upper limit of normal and serum creatinine concentration \\< 1.1 mgs%, random blood sugar \\< 140 mgs%) will be enrolled into the study.\n\nExclusion Criteria:\n\n1. Resides outside area of intake.\n2. Pregnancy and lactation.\n3. Patients with major psychiatric illnesses and severe depression\n4. Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease\n5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state\n6. Previous antituberculosis treatment for more than 1 month\n7. Patients on ART -'}, 'identificationModule': {'nctId': 'NCT00351702', 'briefTitle': 'Preventive Therapy for Tuberculosis in HIV Infected Persons', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuberculosis Research Centre, India'}, 'officialTitle': 'Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons', 'orgStudyIdInfo': {'id': 'trc20B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isoniazid', 'description': 'Isoniazid (300mg) daily for 36 months', 'interventionNames': ['Drug: Isoniazid with Ethambutol']}, {'type': 'EXPERIMENTAL', 'label': 'Isoniazid + Ethambutol', 'description': 'Isoniazid (300 mg) + Ethambutol (800 mg) daily for 6 months', 'interventionNames': ['Drug: Isoniazid with Ethambutol']}], 'interventions': [{'name': 'Isoniazid with Ethambutol', 'type': 'DRUG', 'description': 'Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months', 'armGroupLabels': ['Isoniazid', 'Isoniazid + Ethambutol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600 031', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Tuberculosis Research Centre', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'overallOfficials': [{'name': 'Soumya Swaminathan, MD MNAMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuberculosis Research Centre, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuberculosis Research Centre, India', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dr C Padmapriyadarsini', 'investigatorAffiliation': 'Tuberculosis Research Centre, India'}}}}