[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374822":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":56,"responsibleParty":74,"collaborators":10,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A, group A1",null,"40 patients on suppressive antiretroviral therapy (HIV RNA \\\u003C50 copies \u002F ml for at least 4 years) initiated during the chronic phase : CD4 count less than 500 cells \u002F ml at the time of inclusion in the study",[13],"Biological: expression of a panel",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort A, group A2","40 patients on suppressive antiretroviral therapy (HIV RNA \\\u003C50 copies \u002F ml for at least 4 years) initiated during the chronic phase: CD4 count above 500 cells \u002F ml at the time of inclusion in the study",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort B","20 patients on suppressive antiretroviral therapy (HIV RNA \\\u003C50 copies \u002F ml for at least 4 years) initiated since the primary-infection (within 4 months after acute infection)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort C, group C1","20 patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy: HIV diagnosis made during primary infection (within 4 months of infection)",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort C, group C2","20 patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count above 200 cells\u002Fml at the time of inclusion in the study",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort C, group C3","20 patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count less than 200 cells\u002Fml at the time of inclusion in the study",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort D","20 patients who have undetectable plasma HIV RNA (HIV RNA \\\u003C50 copies \u002F ml ) without antiretroviral therapy, either spontaneously (HIV controllers or elite controllers) or after treatment interruption (post-treatment controllers).",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"BIOLOGICAL","expression of a panel","Quantify, by droplet digital PCR, the expression of a panel of 7 genes (+ GALIG) involved in autophagy2 on sub-populations (CD4+ and CD8+ lymphocytes and monocytes) after their sorting using magnetic bead cell then RNA extraction Evaluate, on a functional test (as previously described1), whether the observed expression dysregulation is associated with a deregulation of the autophagic function, whether constitutive or induced.",[9,15,19,23,27,31,35],[45],{"name":46,"affiliation":47,"role":48},"Laurent HOCQUELOUX, Dr","CHR d'orléans","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Aurélie DESPUJOLS","CONTACT","0238744071","+33","aurelie.despujols@chr-orleans.fr",[57],{"facility":58,"status":59,"city":60,"state":10,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"CHU Orleans","RECRUITING","Orléans","45067","France","FR",{"type":65,"coordinates":66},"Point",[67,68],1.90407,47.90248,{"lat":68,"lon":67},[71,73],{"name":46,"role":52,"phone":10,"phoneExt":10,"email":72},"laurent.hocquelous@chr-orleans.fr",{"name":46,"role":48,"phone":10,"phoneExt":10,"email":10},{"type":75,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100374822","study-of-autophagy-and-the-effects-of-galig-gene-products-in-hiv-1-infected-patients-who-are-under-antiretroviral-therapy-since-primary-infection-chronic-phase-or-never-treated-100374822",false,"NCT04160455","Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.","ATGALIG-HIV","Inclusion Criteria:\n\nGeneral criteria:\n\n* Age \\>=18 years\n* Man or woman\n* Infected with HIV-1 (and not co-infected with HIV-2)\n* Followed at Orleans' Regional Hospital\n* Patient belonging to one of the predefined cohorts\u002Fgroups (see below)\n* Patient having provided a written consent\n\nSpecific profiles of HIV-infected patients for the ATGALIG-HIV study:\n\nCohort A: patients on suppressive antiretroviral therapy (HIV RNA \\\u003C50 copies \u002F ml for at least 4 years) initiated during the chronic phase, divided into 2 groups according to the following criteria:\n\n* group A1: CD4 count less than 500 cells \u002F ml at the time of inclusion in the study\n* group A2: CD4 count above 500 cells \u002F ml at the time of inclusion in the study Cohort B: patients on suppressive antiretroviral therapy (HIV RNA \\\u003C50 copies \u002F ml for at least 4 years) initiated since the primary-infection (within 4 months after acute infection)\n\nCohort C: patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy, divided into the following 3 groups:\n\n* group C1: HIV diagnosis made during primary infection (within 4 months of infection)\n* group C2: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count above 200 cells\u002Fml at the time of inclusion in the study\n* group C3: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count less than 200 cells\u002Fml at the time of inclusion in the study Cohort D: patients who have undetectable plasma HIV RNA (HIV RNA \\\u003C50 copies \u002F ml ) without antiretroviral therapy, either spontaneously (HIV controllers or elite controllers) or after treatment interruption (post-treatment controllers)\n\nExclusion Criteria:\n\n* Patient unable, according to the investigator, to meet the requirements of the protocol\n* Pregnant or lactating woman\n* Patient with a history of inflammatory bowel disease, malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction that, in the judgment of the investigator, could interfere with the interpretation of the results.\n* Presence of coagulation abnormality or unexplained bleeding history\n* Treatment with oral or injectable anticoagulant (curative or preventive)\n* Patient covered by Article L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (including minors and protected adults)\n* Patient under guardianship or curatorship\n* Patient who uncovered by French health insurance Patient participating in another clinical trial, evaluating a treatment","ALL","18 Years",{"count":86,"type":87},180,"ESTIMATED","OBSERVATIONAL","Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area.\n\nOur main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA \\\u003C50 copies \u002F ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).",[91,92,93,94],"Autophagy","Galectins","HIV Infections","Highly Active Antiretroviral Therapy",[96,97,98,99,100],"Antiretroviral therapy","basal autophagy","GALIG gene","HIV","apoptosis","2025-12-22",{"date":103,"type":104},"2025-12-30","ACTUAL",{"date":106,"type":104},"2019-11-07",{"date":108,"type":87},"2039-11-07",{"name":5,"class":6},1]