[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03895645":3,"trial-entities:NCT03895645":62,"trial-summary:NCT03895645":67},{"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":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":35,"minimum_age":36,"maximum_age":37,"healthy_volunteers":38,"eligibility_criteria":39,"std_ages":43,"locations":46,"central_contacts":55,"overall_officials":56,"references":60,"see_also_links":61},"NCT03895645","999919074","Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)","Connors Protocol for the Management and Use of Stored Human Specimens","ENROLLING_BY_INVITATION","2029-12-31","2025-12-02","2026-08-04","2026-08-07","National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,"Background:\n\nThe HIV research program is part of the National Institute of Allergy and Infectious Diseases. The program aims to learn more about HIV. It also aims to improve the health of people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided samples or data. They consented for their samples or data to be used for future research. Researchers want to keep studying the stored samples and data.\n\nObjective:\n\nTo give approved researchers access to stored samples and data after the study of sample origin is over. To do this with human subjects protection oversight by the NIH institutional review board (IRB).\n\nEligibility:\n\nThe study populations were defined by the protocols under which the samples or data were obtained: 11-I-0259, 13-I-0081, and 14-I-0011.\n\nDesign:\n\nAll participants consented to provide blood or other samples. Their consent included future use of the samples.\n\nResearchers will not contact participants without prior approval of the IRB or the original study protocol.\n\nSamples will be labeled with a code. They will not be labeled with information that identifies the participants.\n\nParticipants data will be stored in computers. The computers will be protected with passwords.\n\nThis protocol will be kept open as long as the samples or data can be used for future research. When there is no longer a need, the samples may be moved if the IRB approves this. Otherwise they will be destroyed.\n\n...","The HIV intramural research program of NIAID conducts clinical investigations to increase our\n\nknowledge of the biology, pathogenesis and immunology of HIV infection and vaccine\n\ndevelopment. After all study-related interventions, follow-up, and primary specimen and data\n\nanalyses are complete for an IRB-approved protocol, some human specimens may remain in\n\nstorage, and data may continue to be analyzed to meet secondary and exploratory objectives. This protocol will allow for additional laboratory and data analyses to be continued to complete the analyses described under closed NIAID protocol #14-I-0011, Phase 1 Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers.",[19],"Healthy Volunteer Samples",[21,22],"Stored Samples","Natural History","OBSERVATIONAL",[],{"count":26,"type":27},1000,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Continued analysis","The objective of this protocol is to continue to have human subjects' protection oversight by the NIH IRB while making stored specimens and\u002For data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol.","Ongoing",[],"ALL","18 Years","116 Years",false,{"inclusion":40,"exclusion":41,"raw_text":42},[],[],"* The study populations were defined by the original protocols under which the stored specimens and\u002For data were collected. The total population included on this omnibus protocol comprises the\n\npopulations of other protocols.",[44,45],"ADULT","OLDER_ADULT",[47],{"facility":13,"city":48,"state":49,"zip":50,"country":51,"geoPoint":52},"Bethesda","Maryland","20892","United States",{"lat":53,"lon":54},38.98067,-77.10026,[],[57],{"name":58,"affiliation":13,"role":59},"Mark Connors, M.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":63,"biomarkers":66},[64,65],"Healthy Volunteers","HIV Infection",[],{"nct_id":4,"found":38,"summary":15,"prompt_version":15}]