Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-26 @ 3:34 PM
Study NCT ID:
NCT04304768
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid, HIV and Immune System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the antibody response', 'timeFrame': 'Baseline, 4 weeks, 6 months', 'description': 'Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.'}], 'secondaryOutcomes': [{'measure': 'Immune activation levels', 'timeFrame': 'Baseline', 'description': 'Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.'}, {'measure': 'Inflammation biomarker levels', 'timeFrame': 'Baseline', 'description': 'Plasma levels of Interleukin (IL)-6, IL-8, IL-12, IL-17, IL-22, Tumor necrosis factor (TNF) and monocyte activation markers soluble CD14 and soluble CD163 will be assessed via Magpix. All the biomarkers will be measured in nanograms/milliliter.'}, {'measure': 'Circulating T follicular helper cell function', 'timeFrame': 'Week 4', 'description': 'T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.'}, {'measure': 'Circulating T follicular helper cell frequency', 'timeFrame': 'Week 4', 'description': 'T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flu vaccine response and HIV'], 'conditions': ['Immune Defect']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people opioid and non opioid users to understand how opioid affect the immune responses (body defenses against infection) to the flu vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Opioid (OP) users/non-users:\n\n1. OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days\n2. Opioid never-users in the past year\n\nAdditional criteria for OP users:\n\n1. OP use for 90 days pre-flu vaccination\n2. Continued OP use for 4 weeks post flu vaccination\n\nFor HIV positive participants:\n\n1\\) HIV infection, as documented by any licensed ELISA kit and confirmed by Western blot at any time prior to study entry. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.\n\nAdditional criteria for HIV positive participants:\n\n1. On ART for at least 1 year with plasma pending viral load (VL) \\<200 copies/mL. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment\n2. CD4 count available in the prior 6 months and \\>200/mm3\n3. Undetectable viral load (\\< 200 copies/mL)\n\nFor HIV negative participants:\n\n1\\) Documented negative HIV test, either by any licensed ELISA or rapid tests within the past 6 months.\n\nFor all participants:\n\n1. Individuals age 18-60 yrs .\n2. No history of other immunodeficiency disorders\n3. Not on steroid or other immunosuppressive/immunomodulators medications.\n4. No active malignancies.\n5. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).\n6. Agreeable to receive the influenza vaccination.\n7. Agreeable to participate in study for a complete course of study full visits.\n8. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).\n2. Non-adherence to ART for HIV+\n3. Unable to provide informed consent.\n4. Other comorbid conditions such as diabetes mellitus type 2 (DMT2)\n5. Influenza vaccination already given during the current vaccination season.'}, 'identificationModule': {'nctId': 'NCT04304768', 'briefTitle': 'Opioid, HIV and Immune System', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Immune Dysfunction in HIV+ Opioid Users', 'orgStudyIdInfo': {'id': '20200178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV positive opioid users', 'description': 'Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study', 'interventionNames': ['Biological: Fluzone Quadrivalent']}, {'type': 'EXPERIMENTAL', 'label': 'HIV positive non-opioid users', 'description': 'Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study', 'interventionNames': ['Biological: Fluzone Quadrivalent']}, {'type': 'EXPERIMENTAL', 'label': 'HIV negative opioid users', 'description': 'Participants will receive flu vaccination as part of the study', 'interventionNames': ['Biological: Fluzone Quadrivalent']}, {'type': 'EXPERIMENTAL', 'label': 'HIV negative non-opioid users', 'description': 'Participants will receive flu vaccination as part of the study', 'interventionNames': ['Biological: Fluzone Quadrivalent']}], 'interventions': [{'name': 'Fluzone Quadrivalent', 'type': 'BIOLOGICAL', 'otherNames': ['Influenza vaccination'], 'description': '0.5 ml prefilled syringe administrated intramuscularly', 'armGroupLabels': ['HIV negative non-opioid users', 'HIV negative opioid users', 'HIV positive non-opioid users', 'HIV positive opioid users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suresh Pallikkuth, PhD', 'role': 'CONTACT', 'email': 'SPallikkuth@med.miami.edu', 'phone': '7862019897'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Savita Pahwa, MD', 'role': 'CONTACT', 'email': 'spahwa@med.miami.edu', 'phone': '3052437732'}, {'name': 'Suresh Pallikkuth, PhD', 'role': 'CONTACT', 'email': 'SPallikkuth@med.miami.edu', 'phone': '3052435315'}], 'overallOfficials': [{'name': 'Savita Pahwa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Savita Pahwa', 'investigatorAffiliation': 'University of Miami'}}}}