Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 4:11 AM
Study NCT ID:
NCT01206933
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory analysis of Tat Protein', 'timeFrame': 'Single sample analysis', 'description': 'The validation that HIV Tat protein is a potent inducer of HCV in dual infected patients will likely lead to anti-tat therapy to manage HCV patients for whom treatment options are rather limited.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/HCV Coinfection', 'Tat Protein', 'HCV'], 'conditions': ['Human Immunodeficiency Virus (HIV)', 'Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.', 'detailedDescription': 'Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four groups of subjects will be included in this study, with 5 participants in each group:\n\n1. detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA\n2. undetectable HIV RNA (treated) and detectable HCV RNA\n3. undetectable HIV RNA (treated) and undetectable HCV RNA\n4. undetectable HCV RNA (mono-infected)\n5. detectable HCV RNA (mono-infected)\n6. detectable HIV RNA (mono-infected)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets one of the following criteria:\n\n 1. detectable HIV RNA and detectable HCV RNA\n 2. undetectable HIV RNA (treated) and detectable HCV RNA\n 3. undetectable HIV RNA (treated) and undetectable HCV RNA\n 4. undetectable HCV RNA (mono-infected)\n 5. detectable HCV RNA (mono-infected)\n 6. detectable HIV RNA (mono-infected)\n\nParticipants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01206933', 'briefTitle': 'The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.', 'orgStudyIdInfo': {'id': 'GWUIRB #061012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Detectable HIV RNA and HCV RNA', 'description': 'HIV and HCV co-infected with detectable HIV RNA and HCV RNA'}, {'label': 'Undetectable HIV and Detectable HCV', 'description': 'HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA.'}, {'label': 'Undetectable HIV and HCV', 'description': 'HIV and HCV infected, Undetectable HIV RNA and HCV RNA'}, {'label': 'Undetectable HCV', 'description': 'HCV(mono-infected,) HCV RNA undetectable'}, {'label': 'Detectable HCV RNA', 'description': 'Monoinfected HCV, detectable RNA'}, {'label': 'Detectable HIV RNA', 'description': 'Monoinfected HIV, Detectable RNA'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'David Parenti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}