NCT07778459 · National Institute of Allergy and Infectious Diseases (NIAID)
Expanding HOPE Liver
What this study is about
This is a forward-looking, conducted at multiple hospitals 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.
View original scientific description
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.
Primary outcome measures
Incidence of a composite event of opportunistic infection or cancer in Human Immunodeficiency Virus (HIV)-infected donor (HIV D+)/recipient (R+) compared with HIV-uninfected donor (HIV D-)/recipient (R+) liver transplant recipients
Time frame: From transplant through 4 years post-transplant
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Recipient Inclusion Criteria
- Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant
- 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
- Participant has documented HIV infection by any licensed assay or documented history of detectable Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
- Participant is ≥ 18 years old
- 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
- Donation after brain death or cardiac death
- 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
- 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
- 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
- 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
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month, or primary Central Nervous System (CNS) lymphoma
- Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will be followed on study and managed per local site practice
- 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
- Baltimore, Maryland
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations