[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05529342":3,"trial-entities:NCT05529342":74,"trial-summary:NCT05529342":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":41,"sex":46,"minimum_age":47,"maximum_age":26,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":70,"overall_officials":71,"references":72,"see_also_links":73},"NCT05529342","AGT103-T-LTFU","Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T","A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T","ENROLLING_BY_INVITATION","2038-09-29","2022-11","2022-12-02","2022-08-29","American Gene Technologies International Inc.","INDUSTRY",true,"Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.","The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.",[19],"HIV",[21,22,23,24],"Long term follow-up","Genetically modified CD4 T cells","Gene Therapy","Lentivirus vector","OBSERVATIONAL",null,[],{"count":29,"type":30},7,"ESTIMATED",[32],{"type":33,"name":34,"description":35},"BIOLOGICAL","Gene modified therapy","No investigational cell product will be administered",[37],{"measure":38,"description":39,"timeFrame":40},"Assess the incidence of delayed adverse events (AE) to gene therapy","The presence of malignancies, incidence or exacerbation of pre-existing neurologic disorder, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, the new incidence of a hematologic disorder post infusion with AGT103T","1year to 15years post infusion",[42],{"measure":43,"description":44,"timeFrame":45},"The persistence and the immunity impact of the vector-modified T cells","Evaluate sustained impact on immunity measured by CD4 T cell responses to Gag peptides Measure proportion of participants with absence of replication competent lentivirus (RCL) Measure persistence of vector-modified cells (transgene copies per CD4 T cell)","1year to 15 years","ALL","18 Years",false,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\n1. Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial\n2. Provided written informed consent, signed and dated by the study participant in the long-term follow-up study\n\nExclusion Criteria:\n\n1\\. Did not receive the investigational product, AGT103-T",[54,55],"ADULT","OLDER_ADULT",[57,66],{"facility":58,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"Georgetown University","Washington D.C.","District of Columbia","20007","United States",{"lat":64,"lon":65},38.89511,-77.03637,{"facility":67,"city":59,"state":60,"zip":68,"country":62,"geoPoint":69},"Washington Health Institute","20017",{"lat":64,"lon":65},[],[],[],[],{"nct_id":4,"conditions":75,"biomarkers":77},[76],"HIV Infection",[],{"nct_id":4,"found":48,"summary":26,"prompt_version":26}]