Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-28 @ 12:56 PM
Study NCT ID:
NCT05078957
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of the Shannon index between 0 and 5 years in different groups of PLWH', 'timeFrame': 'Five years'}], 'secondaryOutcomes': [{'measure': 'Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)', 'timeFrame': 'Three years'}, {'measure': 'Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for 5 years in different groups of PLWH', 'timeFrame': 'Five years'}, {'measure': 'Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH', 'timeFrame': 'Five years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people.\n\nIn this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis.\n\nThe objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People Living with HIV (PLWH)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals infected with HIV in the stable phase of their disease (absence of disease outbreak and absence of therapeutic modification within 3 months before inclusion),\n* Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 5 years (tolerance of blips \\< 200 copies / mL during this period)\n* Aged ≥ 55 at baseline\n* CD4 + T cell nadir\\> 200 / mm3\n* Giving free and informed written consent\n* Being affiliated with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.\n* Subject not followed regularly in the participating center,\n* Subject only coming for full hospitalization\n* Subject in the primary infection phase of less than 1 year'}, 'identificationModule': {'nctId': 'NCT05078957', 'acronym': 'FRAMIVIH', 'briefTitle': 'Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Européen Marseille'}, 'officialTitle': 'Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV', 'orgStudyIdInfo': {'id': '21-33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Frail PLWH', 'interventionNames': ['Other: Stool sampling', 'Other: Frailty phenotype', 'Other: Blood plasma collection']}, {'label': 'Pre frail PLWH', 'interventionNames': ['Other: Stool sampling', 'Other: Frailty phenotype', 'Other: Blood plasma collection']}, {'label': 'No frail PLWH', 'interventionNames': ['Other: Stool sampling', 'Other: Frailty phenotype', 'Other: Blood plasma collection']}], 'interventions': [{'name': 'Stool sampling', 'type': 'OTHER', 'description': 'Stool samples will be collected from participants at baseline and annually during 5 years', 'armGroupLabels': ['Frail PLWH', 'No frail PLWH', 'Pre frail PLWH']}, {'name': 'Frailty phenotype', 'type': 'OTHER', 'description': 'According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.', 'armGroupLabels': ['Frail PLWH', 'No frail PLWH', 'Pre frail PLWH']}, {'name': 'Blood plasma collection', 'type': 'OTHER', 'description': 'Blood plasma collection to measure persistent inflammation and immune activation', 'armGroupLabels': ['Frail PLWH', 'No frail PLWH', 'Pre frail PLWH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Myriam BENNANI', 'role': 'CONTACT'}, {'name': 'Christina PSOMAS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Myriam BENNANI', 'role': 'CONTACT', 'email': 'm.bennani@hopital-europeen.fr', 'phone': '0413428351'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}