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HIV InfectionNCT07778459

Expanding HOPE Liver

An observational study of HIV Infection and Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection, Liver Transplant
How many people
80 participants
Where
2 sitesUnited States
Study dates
15 Oct 2026to 31 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In order to have maximum power to precisely estimate the risk of opportunistic infection or cancer attributable to donor HIV status, this trial population (n=80) will be combined with prior HOPE in Action cohorts: HOPE Pilot; HOPE Liver U01 RTB-009, HOPE Liver Long Term Follow Up (LLTF) study. The study will use data from HOPE Pilot and HOPE Liver U01 RTB-009 through end of follow up and participants will also be approached for enrollment to continue long-term follow-up for up to 10 years in the HOPE LLTF study.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Recipient
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • Johns Hopkins University (Site #: 71119)

    Baltimore, Maryland, 21287

    Nadine Jackson, BS, 410-927-2940, nbrown58@jh.edu

    Recruiting

  • Icahn School of Medicine at Mount Sinai (Site # 71115)

    New York, New York, 10029

    Brandy Haydel, 212-241-0255, Brandy.Haydel@mountsinai.org

    Recruiting

Other trials in United States

About this study

Official title: HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver) (RTB-024)

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.

Read the 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.

Keywords
HIV, Liver transplant, Deceased donor
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07778459
Study groupRoleWhat they receive
HIV D-/R+ ArmParticipants who receive a liver or SLK from a donor without HIV (D-) will be in this arm. Participants who accept an HIV suspected false positive (FP) organ will be part of the D-/R+ arm once confirmatory testing confirms the negative HIV status of the donor. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant
HIV D+/R+ ArmProspective cohort of transplant recipients who receive a liver or SLK from a donor with HIV (D+) will be in the HIV D+/R+ arm. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From transplant through 4 years post-transplant

Secondary outcomes (19)

  1. Overall survival measured as time from transplantation to death from any cause

    Measured: From transplant through 4 years post-transplant

  2. Graft survival measured as time from transplantation to graft failure

    Graft failure is defined as any of the following events: re-transplantation; death; allograft nephrectomy; initiation of post-donation chronic dialysis (SLK only).

    Measured: From transplant through 4 years post-transplant

  3. Incidence of bacterial infections post-transplant

    Measured: From transplant through 4 years post-transplant

  4. Incidence of post-transplant cancer

    As determined by local pathology

    Measured: From transplant through 4 years post-transplant

  5. Type of post-transplant cancer

    As determined by local pathology

    Measured: From transplant through 4 years post-transplant

  6. Serious adverse events post-transplant

    Measured: From transplant through 4 years post-transplant

  7. Incidence of rejection events post-transplant

    Measured: From transplant through 4 years post-transplant

  8. Graft function over time as assessed by Fibrosis-4 (FIB-4) Index

    Graft function will be assessed over time using the Fibrosis-4 (FIB-4) Index. FIB-4 is calculated using age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count. Higher FIB-4 values are associated with a greater likelihood of liver fibrosis.

    Measured: From transplant through 4 years post-transplant

  9. Graft function over time as assessed by AST to Platelet Ratio Index (APRI)

    Graft function will be assessed over time using the Aspartate Aminotransferase (AST) to Platelet Ratio Index (APRI). APRI is calculated using AST level, the upper limit of normal for AST, and platelet count. Higher APRI values are associated with a greater likelihood of liver fibrosis.

    Measured: From transplant through 4 years post-transplant

  10. Incidence of Human Immunodeficiency Virus (HIV)-breakthrough post-transplant

    Measured: From transplant through 4 years post-transplant

  11. Incidence of Human Immunodeficiency Virus (HIV) persistent virologic failure post-transplant

    Measured: From transplant through 4 years post-transplant

  12. Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant

    Measured: From transplant through 4 years post-transplant

  13. Incidence of surgical transplant complications

    Measured: During the first year post-transplant

  14. Incidence of vascular transplant complications

    Measured: During the first year post-transplant

  15. Number of Participants with Positive Kaposi Sarcoma Herpesvirus (KSHV) serology

    KSHV serostatus will be assessed using serologic testing for antibodies to KSHV. Participants will be classified as KSHV seropositive or seronegative based on the specified laboratory assay.

    Measured: From transplant through 4 years post-transplant

  16. Kaposi Sarcoma Herpesvirus (KSHV) Polymerase Chain Reaction (PCR) over time

    Measured: From transplant through 4 years post-transplant

  17. Incidence of fungal infections post-transplant

    Measured: From transplant through 4 years post-transplant

  18. Incidence of viral infections post-transplant

    Measured: From transplant through 4 years post-transplant

  19. Incidence of other opportunistic infections post-transplant

    Measured: From transplant through 4 years post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07778459
Sponsor's protocol ID
DAIT RTB-024
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection and Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07778459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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