Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-16 @ 8:01 PM
Study NCT ID:
NCT02964767
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2016-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIV-Tb Confections Among HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dr_ranjankumarsingh@yahoo.com', 'phone': '91+9431263911', 'title': 'Dr. Ranjan K Singh', 'organization': 'SinghRK'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'this is a cross sectional study; findings are limited to the patients attending ART centre.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'other opportunistic infections', 'eventGroups': [{'id': 'EG000', 'title': 'HIV,', 'description': 'HIV patients', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 6, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HIV/Tb. co Infections', 'description': 'Patients with HIV-Tb. co infections', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 2, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'giddiness', 'notes': 'caused by ART drug Efavirenz.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'tablet default'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevalence of HIV/Tb. co Infection', 'description': 'Percentage of Tb. co infections among HIV patients enrolled at ART center.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.HIV', 'description': 'HIV patients only'}, {'id': 'OG001', 'title': '2.HIV/Tb.', 'description': 'Patients with HIV/Tb. co infections'}], 'classes': [{'categories': [{'measurements': [{'value': '314.63', 'spread': '317.49', 'groupId': 'OG000'}, {'value': '254.29', 'spread': '218.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV,', 'description': 'HIV mono infected patients,'}, {'id': 'FG001', 'title': 'HIV/Tb.', 'description': 'Patients with HIV/Tb. co infection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients with HIV infection enrolled at ART centre, Khagaria, India, during June'2015 to May'2016 were recruited.", 'preAssignmentDetails': 'patients, who were Lost to Follow Up (LFU), were excluded from study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1.HIV', 'description': 'patients with mono HIV infections'}, {'id': 'BG001', 'title': '2.HIV/Tb.', 'description': 'Patients with HIV/Tb. co infections'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.26', 'spread': '12.77', 'groupId': 'BG000'}, {'value': '34.97', 'spread': '11.21', 'groupId': 'BG001'}, {'value': '33.63', 'spread': '11.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2016-11-05', 'resultsFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-28', 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.', 'timeFrame': '12 months', 'description': '% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%'}], 'secondaryOutcomes': [{'measure': 'Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.', 'timeFrame': '12 months', 'description': 'CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'HIV-Tb co infection', 'CD4 Cell'], 'conditions': ['HIV']}, 'referencesModule': {'availIpds': [{'url': 'http://www.who.int', 'type': 'Epidemiological report'}, {'url': 'http://www.Wiley.com', 'type': 'Clinical Study Report'}], 'references': [{'pmid': '1894579', 'type': 'BACKGROUND', 'citation': 'Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.'}, {'pmid': '20397949', 'type': 'BACKGROUND', 'citation': 'Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clin Infect Dis. 2010 May 15;50 Suppl 3:S201-7. doi: 10.1086/651492.'}, {'type': 'BACKGROUND', 'citation': 'Global Tuberculosis Report 2016, World Health Organisation, Geneva.'}, {'type': 'BACKGROUND', 'citation': 'Perrin F, Breen R, Lipman M. : HIV and Tuberculosis co-infection. ABC of HIV and AIDS. Michael W, et al (ed): Wiley-Blackwell, BMJ Publishing Group Limited 6:42-47,2012'}]}, 'descriptionModule': {'briefSummary': "A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient and HIV patients would be taken in account.", 'detailedDescription': "Introduction\n\nHIV infection increases the susceptibility of Mycobacterium Tuberculosis (M.Tb.) infection, and hastens its progression due to changes in immune status of the patients. In fact, tuberculosis is now the most common opportunistic infection in patients, who die from AIDS. Immune response in tuberculosis and other infections induces cytokines that enhance replication of HIV, and derives the patient to full blown AIDS. the prevalence of HIV/Tb co-infections have been reported to 0.4% to 20.1% from different regions of northern part of india. India is one of the six countries, those are accounted for 60 percent new cases of tuberculosis, and the BRICS countries collectively account for approximately 50 perce\n\nnt cases of worldwide tuberculosis. The prevalence of multidrug resistant tuberculosis(MDR-TB.) is two-threefold higher in HIV co-infected patients; as HIV infected people rapidly acquire the active disease including resistant strain of M. Tb. and rapidly transmit the disease among population including PLHIV, who in turn, manifest the active drug resistant tuberculosis.\n\nMethods\n\n* This is cohort study among patients of HIV, attending ART (Antiretroviral therapy) center khagaria, Bihar, India during June' 2015 to May' 2016.\n* Patients enrolled at the centre were subjected to screening for Mycobacterium tuberculosis infection by doing ESR, mantoux test, chest x-ray, sputum examination for acid fast bacillus (AFB) and nucleic acid amplification test.\n* HIV/Tb co infected patients were given cotrimoxazole.\n* Patients' data-for example, age, sex, co infection with tuberculosis would be recorded.\n* Sputum positivity, radiological features, and extra pulmonary manifestations would be recorded and statistical analysis would be done\n* Statistical analysis, such as, mean, standard deviation(SD), student T test, p-values would be done. P-value significance would be measured at p \\< .05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of HIV+ enrolled ART centre\n\nExclusion Criteria:\n\n* Lost to follow up patients (LFU)\n* Patients died before the treatment started\n* Children below 5 years'}, 'identificationModule': {'nctId': 'NCT02964767', 'briefTitle': 'HIV-Tb Confections Among HIV Patients', 'organization': {'class': 'INDIV', 'fullName': 'Singh, Ranjan Kumar, M.D.'}, 'officialTitle': 'Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India', 'orgStudyIdInfo': {'id': 'SinghRK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV mono infection', 'description': 'HIV Patients do not have active Mycobacterium Tuberculosis infection'}, {'label': 'HIV-Tb. co infection', 'description': 'Patients with HIV and MycobacteriumTuberculosis co infections'}]}, 'contactsLocationsModule': {'locations': [{'zip': '851204', 'city': 'Khagaria', 'state': 'Bihar', 'country': 'India', 'facility': 'ART centre, Sadar Hospital', 'geoPoint': {'lat': 25.5022, 'lon': 86.46708}}], 'overallOfficials': [{'name': 'Ranjan K Singh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physician cum nodal officer, ART centre, Khagaria, India.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singh, Ranjan Kumar, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nodal officer of ART centre, Sadar Hospital.', 'investigatorFullName': 'Ranjan Kumar Singh', 'investigatorAffiliation': 'Singh, Ranjan Kumar, M.D.'}}}}