Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-12 @ 10:40 PM
Study NCT ID:
NCT03976258
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}, {'id': 'D008691', 'term': 'Methadone'}, {'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C000624616', 'term': 'vivitrol'}, {'id': 'D003932', 'term': 'Heroin'}], 'ancestors': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, serum, urine, stool, peripheral blood mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma soluble CD14 concentration', 'timeFrame': '48 weeks', 'description': 'soluble marker of monocyte activation'}, {'measure': 'Change in Endopat measure of microvascular function', 'timeFrame': '48 weeks', 'description': 'Measure of endothelial function'}, {'measure': 'Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)', 'timeFrame': '48 weeks', 'description': 'Measure of vascular inflammation'}, {'measure': 'Change in plasma Interferon Gamma-Induced Protein 10 concentration', 'timeFrame': '48 weeks', 'description': 'soluble marker of inflammation'}, {'measure': 'Change in plasma intestinal fatty acid binding protein concentration', 'timeFrame': '48 weeks', 'description': 'soluble marker of gut integrity'}], 'secondaryOutcomes': [{'measure': 'Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry', 'timeFrame': '48 weeks', 'description': 'Measurement of fat stores'}, {'measure': 'Change in aortofemoral pulse wave velocity', 'timeFrame': '48 weeks', 'description': 'Measure of arterial stiffness'}, {'measure': 'Change is waist to hip ratio', 'timeFrame': '48 weeks', 'description': 'Measurement of central obesity'}, {'measure': 'Change in body mass index', 'timeFrame': '48 weeks', 'description': 'Body measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heroin', 'HIV', 'inflammation', 'cardiovascular'], 'conditions': ['HIV Infection', 'Opioid-use Disorder', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.', 'detailedDescription': 'This is a 48-week matched, prospective, observational, cohort study of HIV-infected adults on antiretroviral therapy who actively use heroin or who have never used heroin. The overarching goals are 1) to define the extent and specifics of immune activation in HIV-infected IV heroin users; 2) to define the effect of IV heroin on gut integrity and permeability, and the relationship of gut integrity alteration and immune activation; 3) importantly, to study the reversibility of immune activation, inflammation, and gut dysfunction after cessation of IV heroin, and to that effect, compare strategies for medication assisted treatment-buprenorphine/naloxone versus methadone or vivitrol maintenance; 4) to study if heightened immune activation associated with active intravenous drug use (IVDU) is associated with higher cardiovascular disease risk, including endothelial dysfunction and arterial inflammation, and if these effects are reversible with buprenorphine/naloxone or methadone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults ages 18 to 80 years with and without HIV infection using heroin or initiating treatment for heroin use or not using heroin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection or no HIV infection\n* 18 years or older\n* HIV-1 RNA \\< 400 if HIV-infected and on antiretroviral therapy\n* On stable antiretroviral therapy at least 12 weeks with cumulative duration of at least a year for HIV-infected if on antiretroviral therapy\n* Currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past for active heroin group\n* Initiating medication assisted treatment for active heroin use initiating medication assisted treatment groups\n\nExclusion Criteria:\n\n* Active infection, malignancy or other inflammatory condition\n* Uncontrolled diabetes or hypothyroidism\n* Known cardiovascular disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03976258', 'briefTitle': 'Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'officialTitle': 'The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV', 'orgStudyIdInfo': {'id': 'IRB17-00336 and IRB17-00429'}, 'secondaryIdInfos': [{'id': '1R01DA044576-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA044576-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-infected adults actively using heroin', 'description': 'HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past.', 'interventionNames': ['Drug: Heroin']}, {'label': 'HIV-infected adults never having used heroin', 'description': 'HIV-infected adults on antiretroviral therapy matched to HIV-infected adults actively using heroin by age, sex and CD4+ count.'}, {'label': 'HIV-infected adults initiating buprenorphine/naloxone', 'description': 'HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone.', 'interventionNames': ['Drug: buprenorphine/naloxone']}, {'label': 'HIV-uninfected adults initiating buprenorphine/naloxone', 'description': 'HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone.', 'interventionNames': ['Drug: buprenorphine/naloxone']}, {'label': 'HIV-infected adults initiating methadone', 'description': 'HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone', 'interventionNames': ['Drug: Methadone']}, {'label': 'HIV-infected adults initiating Vivitrol', 'description': 'HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol.', 'interventionNames': ['Drug: Naltrexone Injection']}, {'label': 'HIV-uninfected adults initiating methadone', 'description': 'HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone.', 'interventionNames': ['Drug: Methadone']}, {'label': 'HIV-uninfected adults initiating Vivitrol', 'description': 'HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol.', 'interventionNames': ['Drug: Naltrexone Injection']}], 'interventions': [{'name': 'buprenorphine/naloxone', 'type': 'DRUG', 'description': 'This is an observational study. Buprenorphine/naloxone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.', 'armGroupLabels': ['HIV-infected adults initiating buprenorphine/naloxone', 'HIV-uninfected adults initiating buprenorphine/naloxone']}, {'name': 'Methadone', 'type': 'DRUG', 'description': 'This is an observational study. Methadone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.', 'armGroupLabels': ['HIV-infected adults initiating methadone', 'HIV-uninfected adults initiating methadone']}, {'name': 'Naltrexone Injection', 'type': 'DRUG', 'otherNames': ['Vivitrol'], 'description': 'This is an observational study. Naltrexone injection for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.', 'armGroupLabels': ['HIV-infected adults initiating Vivitrol', 'HIV-uninfected adults initiating Vivitrol']}, {'name': 'Heroin', 'type': 'DRUG', 'description': 'This is an observational study. Participants using heroin will be enrolled into this group.', 'armGroupLabels': ['HIV-infected adults actively using heroin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metrohealth Medical center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Corrilynn O Hileman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MetroHealth Medical Center'}, {'name': 'Grace A McComsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Corrilynn Hileman', 'investigatorAffiliation': 'MetroHealth Medical Center'}}}}