Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 1:20 AM
Study NCT ID:
NCT01285050
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023241', 'term': 'Antiretroviral Therapy, Highly Active'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dthomas@jhmi.edu', 'phone': '410-502-6043', 'title': 'David Thomas', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pre Post ART', 'description': 'HCV and HIV viral load pre and post antiretroviral therapy\n\nAnti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.\n\nraltegravir: HIV medication, 400 mg twice daily by mouth\n\nEmtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'bleeding', 'notes': 'As an expected potential complication of liver biopsy, one patient had bleeding that required observation in the hospital. No residual complications were noted.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre ART HCV RNA Decline', 'description': 'HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)\n\nInterferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.\n\nART included:\n\nraltegravir: HIV medication, 400 mg twice daily by mouth\n\nEmtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth'}, {'id': 'OG001', 'title': 'Post ART HCV Decline', 'description': 'HCV RNA determined by RT-PCR and expressed as log IU/ml after ART'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '1.15'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '1.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after interferon administration', 'description': 'HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.', 'unitOfMeasure': 'log IU/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre Post ART', 'description': 'HCV and HIV viral load pre and post antiretroviral therapy\n\nAnti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.\n\nraltegravir: HIV medication, 400 mg twice daily by mouth\n\nEmtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre Post ART', 'description': 'HCV and HIV viral load pre and post antiretroviral therapy\n\nAnti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.\n\nraltegravir: HIV medication, 400 mg twice daily by mouth\n\nEmtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV infected', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2011-01-26', 'resultsFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-06', 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCV RNA', 'timeFrame': '48 hours after interferon administration', 'description': 'HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Human immunodeficiency virus', 'Acquired Immune Deficiency Syndrome Virus', 'AIDS Virus', 'Immunodeficiency Virus, Human', 'Virus, Human Immunodeficiency', 'Hepatitis C', 'Hepatitis C, chronic', 'Hepatitis C virus', 'Hepatitis C antibodies', 'Hepatitis C antigens'], 'conditions': ['HIV Infection', 'Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '28586923', 'type': 'DERIVED', 'citation': 'Kandathil AJ, Breitwieser FP, Sachithanandham J, Robinson M, Mehta SH, Timp W, Salzberg SL, Thomas DL, Balagopal A. Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs. Ann Intern Med. 2017 Jul 4;167(1):1-7. doi: 10.7326/M17-0085. Epub 2017 Jun 6.'}, {'pmid': '28358734', 'type': 'DERIVED', 'citation': 'El-Diwany R, Breitwieser FP, Soliman M, Skaist AM, Srikrishna G, Blankson JN, Ray SC, Wheelan SJ, Thomas DL, Balagopal A. Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals. AIDS. 2017 Jun 19;31(10):1405-1414. doi: 10.1097/QAD.0000000000001480.'}]}, 'descriptionModule': {'briefSummary': 'The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).', 'detailedDescription': 'We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Human\n* Able to provide written informed consent\n* HIV antibody positive\n* HIV viral load positive\n* HIV treatment naive\n* Hepatitis C antibody positive\n* Hepatitis C viral load positive\n* Hepatitis C treatment naive\n* Approved to take HIV medications for minimum 9 months\n* Willing to use contraception, Life expectancy greater than 2 years\n\nExclusion Criteria:\n\n* Significant opportunistic infections within 12 month\n* Hepatitis B positive\n* Evidence of liver cirrhosis\n* Decompensated liver disease\n* Chronic alcohol abuse\n* Allergy to raltegravir, tenofovir, and/or emtricitabine\n* Active or suspected malignancy\n* Sarcoidosis\n* Active TB\n* Coronary artery disease\n* Uncontrolled seizures\n* Untreated thyroid disease\n* Untreated diabetes\n* Weight greater than 125 kg\n* Severe depression or severe psychiatric disorder\n* Ongoing alcohol or illicit drug use\n* Pregnant, nursing, pr planning to become pregnant\n* Allergy to interferon'}, 'identificationModule': {'nctId': 'NCT01285050', 'briefTitle': 'Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'NA00040361'}, 'secondaryIdInfos': [{'id': 'R01DA013806', 'link': 'https://reporter.nih.gov/quickSearch/R01DA013806', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pre post ART', 'description': 'HCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART)', 'interventionNames': ['Drug: Antiretroviral therapy (ART)', 'Drug: raltegravir', 'Drug: Emtricitabine and tenofovir disoproxil fumarate']}], 'interventions': [{'name': 'Antiretroviral therapy (ART)', 'type': 'DRUG', 'description': 'Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.', 'armGroupLabels': ['pre post ART']}, {'name': 'raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': 'raltegravir is an HIV medication given 400 mg twice daily by mouth', 'armGroupLabels': ['pre post ART']}, {'name': 'Emtricitabine and tenofovir disoproxil fumarate', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': 'Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth', 'armGroupLabels': ['pre post ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Infectious Diseases', 'investigatorFullName': 'David Thomas', 'investigatorAffiliation': 'Johns Hopkins University'}}}}