Expanding HIV-positive donor livers for HIV-positive recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective observational study evaluating liver and simultaneous liver-kidney transplants from deceased HIV-positive donors to recipients with HIV. The primary goal is to see if HIV D+/R+ transplants have a higher risk of opportunistic infections or cancer than HIV D-/R+ transplants. Participants will be followed for 6 months to up to 4 years, and data from prior HOPE in Action liver studies will be incorporated to improve precision. Biospecimens will be collected to study virologic and immunologic factors relevant to transplant outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins University (Site #: 71119)
  Baltimore, Maryland, United States Recruiting
• Icahn School of Medicine at Mount Sinai (Site # 71115)
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.