Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05065905
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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': 'D012192', 'term': 'Retroviridae 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': '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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007371', 'term': 'Interferon-gamma'}], 'ancestors': [{'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016215', 'term': 'Macrophage-Activating Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mechnik@mail.ru', 'phone': '+78125439609', 'title': 'Dr. med. Sc., Prof. Tamara Sologub', 'organization': 'Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health, Saint-Petersburg, Russia, 195067'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Interferon Daily', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'All participants receive only basic antimicrobial treatment\n\nInterventions:\n\nDrug: Antituberculosis complex therapy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sputum Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'OG001', 'title': 'Interferon Daily', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'OG002', 'title': 'Control', 'description': 'All participants receive only basic antimicrobial treatment\n\nInterventions:\n\nDrug: Antituberculosis complex therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': 'Precentage of participants with negative sputum culture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Hemoglobin Level', 'timeFrame': 'Screening, Week 8', 'description': 'Level of hemoglobin (g/L)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Leucocytes Level', 'timeFrame': 'Screening, Week 4', 'description': 'Number of leukocytes', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'CD3', 'timeFrame': 'Screening, Week 4', 'description': 'CD3 cells level in absolute numbers and percents', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'CD4', 'timeFrame': 'Screening, Week 4', 'description': 'CD4 cells level in absolute numbers and percents', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'CD8', 'timeFrame': 'Screening, Week 4', 'description': 'CD8 cells level in absolute numbers and percents', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'CD4/CD8', 'timeFrame': 'Screening, Week 4', 'description': 'Immunoregulatory index value', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'FG001', 'title': 'Interferon Daily', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'FG002', 'title': 'Control', 'description': 'All participants receive only basic antimicrobial treatment\n\nInterventions:\n\nDrug: Antituberculosis complex therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'BG001', 'title': 'Interferon Daily', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy\n\nInterferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein'}, {'id': 'BG002', 'title': 'Control', 'description': 'All participants receive only basic antimicrobial treatment\n\nInterventions:\n\nDrug: Antituberculosis complex therapy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'under 18 y.o.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '18-50 y.o.', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'over 50 y.o.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2006-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2021-09-07', 'resultsFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-25', 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum Culture', 'timeFrame': 'Week 4', 'description': 'Precentage of participants with negative sputum culture'}], 'secondaryOutcomes': [{'measure': 'Average Hemoglobin Level', 'timeFrame': 'Screening, Week 8', 'description': 'Level of hemoglobin (g/L)'}, {'measure': 'Leucocytes Level', 'timeFrame': 'Screening, Week 4', 'description': 'Number of leukocytes'}, {'measure': 'CD3', 'timeFrame': 'Screening, Week 4', 'description': 'CD3 cells level in absolute numbers and percents'}, {'measure': 'CD4', 'timeFrame': 'Screening, Week 4', 'description': 'CD4 cells level in absolute numbers and percents'}, {'measure': 'CD8', 'timeFrame': 'Screening, Week 4', 'description': 'CD8 cells level in absolute numbers and percents'}, {'measure': 'CD4/CD8', 'timeFrame': 'Screening, Week 4', 'description': 'Immunoregulatory index value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interferon gamma, IFN-g, HIV infection, tuberculosis'], 'conditions': ['HIV Coinfection', 'Aids/Hiv Problem', 'Tuberculosis, Pulmonary', 'Human Immunodeficiency Virus', 'Lentivirus Infections', 'RNA Virus Infections']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.', 'detailedDescription': 'Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.\n\nInterferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.\n\nThe aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.\n\nThe treatment regimen in this study will also include a basic antituberculosis therapy.\n\nThe available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.\n\nThe study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must sign the form of informed consent and agree to follow the protocol requirements\n* Women willing to participate in the study must protect against possible pregnancy during all the study long\n* Age 18-50 years\n* Pulmonary tuberculosis\n* HIV/AIDS\n* Indication for in-patient standard antituberculosis treatment\n\nExclusion Criteria:\n\n* Investigational research agents received within 30 days before the screening and participation in other clinical trials\n* Immunosuppressive medications received within 6 months before the screening\n* Current drug abuse for more than 3 years\n* Contraindications to interferons of standard antimicrobial therapy'}, 'identificationModule': {'nctId': 'NCT05065905', 'acronym': 'MSPB_TB', 'briefTitle': 'Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPP Pharmaclon Ltd.'}, 'officialTitle': 'A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis', 'orgStudyIdInfo': {'id': 'MSPB_TB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interferon', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy', 'interventionNames': ['Drug: Interferon-Gamma']}, {'type': 'EXPERIMENTAL', 'label': 'Interferon daily', 'description': 'All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day\n\nInterventions:\n\nDrug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy', 'interventionNames': ['Drug: Interferon-Gamma']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'All participants receive only basic antimicrobial treatment\n\nInterventions:\n\nDrug: Antituberculosis complex therapy'}], 'interventions': [{'name': 'Interferon-Gamma', 'type': 'DRUG', 'otherNames': ['Ingaron', 'Interferon gamma human recombinant'], 'description': 'received by microbiological synthesis; specific antiviral activity on cells is 2x10\\*7 Units per mg of protein', 'armGroupLabels': ['Interferon', 'Interferon daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '195067', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'City Tuberculosis Hospital #2 of Saint-Petersburg', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Vladimir Shmelev, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SPP Pharmaclon Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPP Pharmaclon Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'North-Western State Medical University named after I.I.Mechnikov', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}