Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-03-01 @ 1:00 PM
Study NCT ID:
NCT00959166
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2009-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], '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': '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': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.winston@imperial.ac.uk', 'phone': '+44 (0)20 3312 1603', 'title': 'Prof Alan Winston', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'HIV/Acute HCV Coinfection', 'description': 'Subjects with HIV/acute HCV coinfection', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HIV Mono', 'description': 'HIV-infected individuals without hepatitis C co-infection', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV/Acute HCV Coinfection', 'description': 'Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.'}, {'id': 'OG001', 'title': 'HIV Mono', 'description': 'HIV-infected individuals without hepatitis C co-infection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.', 'unitOfMeasure': 'binding potential ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 subjects in total had PET scans and were included in the PET outcome'}, {'type': 'SECONDARY', 'title': 'Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV/Acute HCV Coinfection', 'description': 'Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.'}, {'id': 'OG001', 'title': 'HIV Mono', 'description': 'HIV-infected individuals without hepatitis C co-infection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios.\n\nBy quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24/12 subjects in each study group had MR spectroscopy and could be included in this analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV/Acute HCV Coinfection', 'description': 'Subjects with HIV/acute HCV coinfection'}, {'id': 'FG001', 'title': 'HIV Mono', 'description': 'HIV-infected individuals without hepatitis C co-infection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV/Acute HCV Coinfection', 'description': 'Subjects with HIV/acute HCV coinfection'}, {'id': 'BG001', 'title': 'HIV Mono', 'description': 'HIV-infected individuals without hepatitis C co-infection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '44'}, {'value': '47', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '56'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time-elapsed since HIV diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '8.5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Current CD4+ cells', 'classes': [{'categories': [{'measurements': [{'value': '590', 'groupId': 'BG000', 'lowerLimit': '458', 'upperLimit': '745'}, {'value': '505', 'groupId': 'BG001', 'lowerLimit': '382', 'upperLimit': '783'}, {'value': '547', 'groupId': 'BG002', 'lowerLimit': '382', 'upperLimit': '783'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of participants receiving antiretroviral therapy', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Plasma HIV viral load below 50c/ml', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2009-08-13', 'resultsFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-21', 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection', 'timeFrame': '30 days', 'description': 'Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.'}], 'secondaryOutcomes': [{'measure': 'Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites', 'timeFrame': '30 days', 'description': 'Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios.\n\nBy quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute hepatitis C', 'HIV', 'Neurocognitive function', 'Neuroinflammation'], 'conditions': ['Acute Hepatitis C', 'HIV', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '22808022', 'type': 'RESULT', 'citation': 'Garvey LJ, Pavese N, Ramlackhansingh A, Thomson E, Allsop JM, Politis M, Kulasegaram R, Main J, Brooks DJ, Taylor-Robinson SD, Winston A. Acute HCV/HIV coinfection is associated with cognitive dysfunction and cerebral metabolite disturbance, but not increased microglial cell activation. PLoS One. 2012;7(7):e38980. doi: 10.1371/journal.pone.0038980. Epub 2012 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals:\n\n* Group 1: Individuals with HIV infection and acute (early) hepatitis C infection\n* Group 2: Individuals with HIV infection\n* Group 3: Healthy volunteers', 'detailedDescription': 'Subtle changes to the brain, which doctors find difficult to detect through conversation or examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently known whether the brain is affected in early (or acute) hepatitis C.\n\nIndividuals wishing to take part will complete a series of tests assessing different aspects of their brain including:\n\n* 2 brain scans using different technology:\n\n * Magnetic resonance imaging (MRI) brain scan with spectroscopy\n * CT PET brain scan\n* A computer game test which measures brain function\n* 2 short questionnaires\n\nResults of these tests will be analyzed and compared between 3 groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV-1 antibody positive for at least 12 months\n2. Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)\n3. HCV genotype 1\n4. Ability to give informed consent\n5. Aged \\> 25 years\n6. Male\n7. Abbreviated Mental Test Score of at least 8/10\n\nExclusion Criteria:\n\n1. Evidence of established cirrhosis or encephalopathy\n2. Commencing or any change to HIV medications within 12 weeks\n3. Active opportunistic infection\n4. Taking anti-depressants or any psychoactive medications within past 4 weeks\n5. Use of benzodiazepines within past 4 weeks\n6. Recent significant head injury\n7. Established dementia\n8. Alcohol dependence or recreational drug misuse\n9. Untreated early syphilis\n10. Hepatitis B infection (HBsAg positive)\n11. Pregnancy\n12. Unable to give informed consent\n13. Any contraindication to MR scanning'}, 'identificationModule': {'nctId': 'NCT00959166', 'briefTitle': 'To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'A Prospective Case-control Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-infection - a PET Study', 'orgStudyIdInfo': {'id': '09/H0712/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HIV/acute HCV coinfection', 'description': 'Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.', 'interventionNames': ['Other: PET scan']}, {'type': 'OTHER', 'label': 'HIV mono', 'description': 'HIV-infected individuals without hepatitis C co-infection', 'interventionNames': ['Other: PET scan']}], 'interventions': [{'name': 'PET scan', 'type': 'OTHER', 'description': 'PET brain scan', 'armGroupLabels': ['HIV mono', 'HIV/acute HCV coinfection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Alan Winston', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}