Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-06 @ 11:55 PM
Study NCT ID:
NCT03298360
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients', 'timeFrame': 'inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV cell reservoir'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.', 'detailedDescription': 'Objectives\n\nPrincipal objective\n\nTo analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.\n\nSecondary objectives\n\nTo analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV reservoir markers, currently being identified, in these same patients\n\nMethodology\n\nPathophysiological study, in patients infected by multi drug-resistant viruses\n\nEstimated enrollment\n\n21 participants (total and per group)\n\nIntervention\n\n167mL blood sample in EDTA tube:\n\n* 160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)\n* 7mL (1tube of 7mL): to measure HIV-RNA in centers\n\nEstimated planning or Study / Trial timetable\n\nStudy start date: September 2017\n\nEnrollment period: 12 months\n\nTotal study duration: 24 months (analyses included)\n\nEstimated study/trial completion date: September 2019 (one year after enrollment of the last patient)\n\nStudy design\n\nCross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV Infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who participated to ANRS139 TRIO trial, and still followed in centers\n* Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated\n* Genotypic resistance profiles available at baseline and before trial\n* Age ≥ 18 years\n* Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).\n* Written informed consent signed by the person and the investigator before any exam performed in the study.\n\nExclusion Criteria:\n\n* HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial\n* Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.\n* Person under legal guardianship or deprived of liberty by a judicial or administrative decision.'}, 'identificationModule': {'nctId': 'NCT03298360', 'acronym': 'ANRS EP63', 'briefTitle': 'A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a', 'orgStudyIdInfo': {'id': 'ANRS EP63 RESTA 32a'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': '167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Monsef BENKIRANE', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}