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Expanding HOPE Liver

RecruitingN/A

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV Infection, Liver Transplant

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

Recipient Inclusion Criteria

1. Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant
2. Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) is able to understand and provide informed consent
3. Participant has documented HIV infection by any licensed assay or documented history of detectable Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
4. Participant is ≥ 18 years old
5. Most recent HIV-1 RNA \<= 50 copies RNA/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. Organ recipients who are unable to tolerate ART due to organ failure or recently started ART may have detectable viral load and still be eligible if a safe and effective antiretroviral regimen to be used by the recipient after transplantation is described

Deceased Donor Criteria

1. Donation after brain death or cardiac death
2. Donors with HIV have confirmed or suspected HIV infection (by medical record history and licensed HIV test). If HIV infection is diagnosed during the donor evaluation process, a second confirmatory test will be required. Organs from donors with suspected false positive HIV screening tests can be used under this protocol
3. Donor has no active opportunistic infections, neoplasms, and/or severe acute retroviral syndrome; if previous history of an opportunistic infection, donor has received appropriate treatment
4. Donor may have any HIV-1 RNA viral load provided a safe, tolerable, and effective post-transplant antiretroviral regimen to be prescribed for the recipient is anticipated, described, and justified
5. Donors with active hepatitis C virus infection (detectable HCV nucleic acid by licensed assay in a Clinical Laboratory Improvement Amendments (CLIA)-certified lab) are acceptable based on local site practice

Exclusion Criteria:

Recipient

1. Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month, or primary Central Nervous System (CNS) lymphoma
2. Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will be followed on study and managed per local site practice
3. Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Locations (2)

Baltimore, Maryland, United States
New York, New York, United States