Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT03774108
Status:
UNKNOWN
Last Update Posted:
2019-12-19
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Systemic Inflammation in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin', 'timeFrame': 'Basal - 8 weeks', 'description': 'Serum levels of proinflammatory cytokines will be quantify by flow cytometry using a Cytometric Bead Array. The cytokine panel to be messured will be as follows:\n\n* IL-1beta\n* IFN-alpha2\n* IFN-gamma\n* TNF-alpha\n* MCP-1\n* IL-6\n* IL-8\n* IL-10\n* IL-12p70\n* IL-17A\n* IL-18\n* IL-23\n* IL-33\n\nThese cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PreDiabetes', 'HIV-1-infection']}, 'referencesModule': {'references': [{'pmid': '27766258', 'type': 'BACKGROUND', 'citation': 'Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. doi: 10.1155/2016/3420638. Epub 2016 Sep 27.'}, {'pmid': '29773933', 'type': 'BACKGROUND', 'citation': 'Arafath S, Campbell T, Yusuff J, Sharma R. Prevalence of and Risk Factors for Prediabetes in Patients Infected With HIV. Diabetes Spectr. 2018 May;31(2):139-143. doi: 10.2337/ds17-0009.'}, {'pmid': '27058351', 'type': 'BACKGROUND', 'citation': 'Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016 Jun 19;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.'}, {'pmid': '25772174', 'type': 'BACKGROUND', 'citation': 'Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. doi: 10.2174/1871530315666150316124019.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.\n\nTo this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level\\> 200 cells / μL.\n\n40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes,\n* Age ≥18 years of age\n* With a diagnosis of HIV-1 infection,\n* That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),\n* Patients with undetectable viral load (\\<40 copies / mL) for at least 12 months,\n* Have a CD4 + level\\> 200 cells / μL,\n* That they do not have a diagnosis of co-infection with HCV or HBV,\n* Patients who do not have a severe alcohol intake (\\<21 glasses / week in men and \\<14 glasses / week in women),\n* Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,\n* Who wish to participate voluntarily in the study and give their written consent.\n\nExclusion Criteria:\n\n* Individuals with a known hypersensitivity / allergy to metformin.\n* Patients with contraindications to the use of metformin \\*.\n* Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.\n* People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.\n* Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association \\*).\n* Patients with indication for the use of statins, aspirin or immunomodulators.'}, 'identificationModule': {'nctId': 'NCT03774108', 'acronym': 'Metfo', 'briefTitle': 'Metformin and Systemic Inflammation in HIV', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients', 'orgStudyIdInfo': {'id': '114/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin Experimental Arm', 'description': 'Metformin 850mg/12 hours, oral, 8 weeks', 'interventionNames': ['Drug: Metformin Hydrochloride 850 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator Arm', 'description': 'Placebo pills/12hours, oral, 8 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Metformin Hydrochloride 850 MG', 'type': 'DRUG', 'description': '8 weeks tratment with oral metformin', 'armGroupLabels': ['Metformin Experimental Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '8 weeks tratment with oral placebo', 'armGroupLabels': ['Placebo Comparator Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Hospital Civil de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Basal - 8 weeks', 'ipdSharing': 'YES', 'description': 'Data from participants will be available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Moises Ramos Solano', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}