Expanding HOPE Liver
Start Date
10/15/2026
Completion Date
8/31/2030
Summary
This is a prospective, multicenter clinical study. The objective is to determine whether a liver transplant from a deceased donor with HIV is associated with an increased risk of opportunistic infection and cancer. Adults with Human Immunodeficiency Virus (HIV) in need of a liver or simultaneous liver-kidney (SLK) transplant who meet study-specified criteria will be offered enrollment in the study. The analytic plan includes an observational cohort of liver and SLK transplant recipients from prior HOPE in Action studies.
Detailed Description
This is a prospective, multicenter observational study of liver transplantation from deceased donors with Human Immunodeficiency Virus (HIV) to recipients with HIV. The primary objective is to determine whether liver transplantation (LT) from donors with HIV to recipients with HIV (HIV D+/R+) is associated with an increased risk of opportunistic infections or cancer compared with LT from donors without HIV to recipients with HIV (HIV D-/R+). Adults with HIV who require a liver transplant or simultaneous liver-kidney (SLK) transplant and meet study eligibility criteria will be enrolled. Participants who receive a liver or SLK transplant from a donor with HIV will be assigned to the HIV D+/R+ cohort. Participants who receive a liver or SLK transplant from a donor without HIV, including donors with suspected false-positive HIV screening tests that are subsequently confirmed HIV negative, will be assigned to the HIV D-/R+ cohort. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant. To improve precision in estimating the association between donor HIV status and the risk of opportunistic infection or cancer, analyses will incorporate observational cohorts from prior HOPE in Action liver transplantation studies, including the HOPE Liver Pilot Study, HOPE Liver U01 (RTB-009), and the HOPE Liver Long-Term Follow-Up (LLTF) Study, where appropriate. In addition to clinical outcomes, biospecimens will be collected to investigate virologic and immunologic mechanisms that may contribute to infection and cancer risk following transplantation from donors with HIV.
Eligibility Criteria
Age Range: 18 years to No maximum
Conditions
Locations
Johns Hopkins University (Site #: 71119)
Baltimore, Maryland 21287
United States
Icahn School of Medicine at Mount Sinai (Site # 71115)
New York, New York 10029
United States