This is a prospective, multicenter, interventional clinical trial assessing the safety and efficacy of HIV+ deceased donor solid liver transplantation for HIV+ recipients (HIV D+/R+). The primary endpoint of the study is time to a composite of all-cause-mortality, transplanted related (graft failure, rejection), and HIV-related (breakthrough, virologic failure of AIDS-defining illness) events. A cohort of stable HIV-infected adults in need of a liver transplant who meet standard and study-specified HIV criteria for organ transplantation will be offered enrollment in the study. Eligible subjects will be enrolled and transplanted and treatment and outcomes data will be documented over four years. The cohort will serve as the source of human specimens to enable further evaluation of the disease and effects of transplantation. Sites will submit the protocol, study materials, and CRFs to their local IRB as well as a consent form on the local template and obtain approval of the study with Johns Hopkins serving as the Coordinating Center. Sites will maintain local approval of the study, providing the NIH through PPD and Johns Hopkins with copies of the approval, renewals, IRB-approved consent forms, updated subject logs and completed consent forms and other necessary regulatory documents including updated delegation of authority logs, current medical licenses, and human subject training certificates. The site principal investigator will remain responsible for the safe and effective conduct of the study at the site. In sum, sites are responsible for cooperating with the Coordinating Center to ensure the successful implementation and administration of the study. Sites will actively identify, consent, and enroll subjects in need of liver transplant ≥18 years of age with documentation of HIV infection.
|Effective start/end date||1/1/19 → 7/31/21|
- Johns Hopkins University (2004130714//1U01AI138897-01)
- National Institute of Allergy and Infectious Diseases (2004130714//1U01AI138897-01)
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