[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519534":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":53,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DRM negative",null,"The cohort of patients, who will meet inclusion criteria, with HIV infections and no drug resistance mutations detected.\n\nEpidemiological (age, sex, origin, sexual preferences) and clinical data (HIV viral load, CD4+ cell count, presence of AIDS-defining diseases, co-infection with HBV and HCV) will be collected at the time of diagnosis.\n\nSubsequent controls of HIV viral load, level of CD4 and CD4\u002FCD8 ratio will be carried out in accordance with the standard of care for an HIV-infected patient (usually every 6-12 months).",[13],"Other: differences in CD4 reconstruction",{"label":15,"type":10,"description":16,"interventionNames":17},"DRM positive","The cohort of patients, who will meet inclusion criteria, with HIV infections and detected primary drug resistance mutations.\n\nEpidemiological (age, sex, origin, sexual preferences) and clinical data (HIV viral load, CD4+ cell count, presence of AIDS-defining diseases, co-infection with HBV and HCV) will be collected at the time of diagnosis.\n\nSubsequent controls of HIV viral load, level of CD4 and CD4\u002FCD8 ratio will be carried out in accordance with the standard of care for an HIV-infected patient (usually every 6-12 months).",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"differences in CD4 reconstruction","Differences in the increase in CD4 lymphocyte count and CD4:CD8 ratio between patients with primary drug resistance mutations and those without these mutations.",[9,15],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Andrzej Załęski, PhD","CONTACT","+48600982185","andrzejzaleski84@wp.pl",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100519534","the-influence-of-primary-hiv-1-drug-resistance-mutations-on-immune-reconstruction-in-plwh-100519534",false,"NCT06044792","The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH","The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in Patients Treated With Antiretroviral Drugs - an Observational Cohort Study.","Inclusion Criteria:\n\n* HIV-1 confirmed infection\n* ART naive patients \\> 18 years\n* virological suppression after 6 months of ART\n* available results of HIV genotyping before the start of ART\n\nExclusion Criteria:\n\n* hematologic neoplasms\n* use of chemotherapy, immunosuppressive drugs and other myelotoxic agents\n* lack of patient's consent to participate in the study","ALL","18 Years","100 Years",{"count":42,"type":43},50,"ESTIMATED","OBSERVATIONAL","Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution.\n\nEvaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.",[47,48,49,50,51,52],"Hiv","AIDS","CD4 Deficiency","ART","Treatment Resistant Disorders","Treatment-Sensitive HIV Infection",[54,55,56,57,58],"HIV","CD4","DRM","drug resistance","immune reconstruction","NOT_YET_RECRUITING","2023-09-17",{"date":62,"type":63},"2023-09-21","ACTUAL",{"date":65,"type":43},"2023-09-30",{"date":67,"type":43},"2028-01-01",{"name":5,"class":6}]