HIVNCT07665372
Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)
A study testing HIV D+/R+ and HIV D-/R+ in people with HIV, run by Johns Hopkins University at 19 sites in United States.
Trial summary
This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- HIV D+/R+ and HIV D-/R+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 19 sitesUnited States
- Study dates
- Nov 2026to Aug 2031
- Phase
- Interventional
- 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
Who may be able to join
- 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 HIV-1 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 Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
Who cannot join
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month duration, or prior primary Central Nervous System (CNS) lymphoma.
- Participant is pregnant or breastfeeding.
- 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
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
William Kitchens, MD, PhD, william.henry.kitchens.jr@emory.edu
William Kitchens, MD, PhD
- Not yet recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Chia-Yu Chiu, MD, chia-yu.chiu@cuanschutz.edu
Chia-Yu Chiu, MD
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Christine Durand, MD, ChristineDurand@jhmi.edu
Christine Durand, MD
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nahel Elias, MD, Elias.Nahel@mgh.harvard.edu
Nahel Elias, MD
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
Valentina Stosor, MD, v-stosor@northwestern.edu
Valentina Stosor, MD
- Not yet recruiting
University of Cincinnati
Cincinnati, Ohio, 45229
Senu Apewokin, MD, apewoksu@ucmail.uc.edu
Senu Apewokin, MD
- Not yet recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Nicholas Marschalk, DO, Nicholas.Marschalk@osumc.edu
Nicholas Marschalk, DO
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
David Wojciechowski, DO, David.Wojciechowski@UTSouthwestern.edu
David Wojciechowski, DO
- Not yet recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Masayuki Nigo, MD MSc, mnigo@houstonmethodist.org
Masayuki Nigo, MD, MSc
- Not yet recruiting
Mayo Clinic, Florida
Jacksonville, Florida, 32224
Shennen Mao, MD, Mao.Shennen@mayo.edu
Shennen Mao, MD
- Not yet recruiting
Ochsner Clinic Foundation
Jefferson, Louisiana, 70121
Jonathan Hand, MD, jonathan.hand@ochsner.org
Jonathan Hand, MD
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Nicholas Nissen, MD, Nicholas.Nissen@cshs.org
Nicholas Nissen, MD
- Not yet recruiting
University of Miami, Miami Transplant Institute
Miami, Florida, 33136
Jacques Simkins-Cohen, MD, jsimkins@med.miami.edu
Jacques Simkins-Cohen, MD
- Not yet recruiting
New York University School of Medicine
New York, New York, 10016
Sapna Mehta, MD, Sapna.Mehta@nyulangone.org
Sapna Mehta, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sander Florman, MD
Sander Florman, MD
- Not yet recruiting
Weill Cornell Medical College
New York, New York, 10065
Catherine B Small, MD, cbs9003@med.cornell.edu
Catherine B Small, MD
- Not yet recruiting
Mayo Clinic, Arizona
Phoenix, Arizona, 85054
Andrew Singer, MD, PhD, Singer.Andrew@mayo.edu
Andrew Singer, MD, PhD
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Ghady Haidar, MD, haidarg@upmc.edu
Ghady Haidar, MD
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Jennifer Price, MD, Jennifer.Price@ucsf.edu
Jennifer Price, MD
About this study
Official title: HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.
Read the detailed description
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.
Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).
- Conditions
- HIV
- Being tested
- HIV D+/R+, HIV D-/R+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV D+/R+Other
Receipt of liver transplant from a deceased donor with HIV
HIV D-/R+Other
Receipt of liver transplant from a deceased donor without HIV
| Study group | Role | What they receive |
|---|---|---|
| HIV D+/R+ | Experimental | People living with HIV who receive livers from deceased donors with HIV Receives: Other: HIV D+/R+ |
| HIV D-/R+ | Experimental | People living with HIV who receive livers from deceased donors without HIV Receives: Other: HIV D-/R+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Cumulative incidence of composite event of opportunistic infection or cancer
Measured: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Secondary outcomes (10)
Participant survival
Time to event (death)
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft survival
Time to event (graft loss)
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant
Cumulative incidence of infections
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence and type of post-transplant cancer as determined by local pathology
Cumulative incidence of cancer determined by local pathology
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Serious adverse events post-transplant
Cumulative incidence of serious adverse events
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of rejection events post-transplant
Cumulative incidence of rejection events
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index
Mean value of graft function
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant
Cumulative incidence of HIV-breakthrough and HIV persistent viral failure
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant
Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
Measured: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of surgical and vascular transplant complications during the first year post-transplant
Cumulative incidence of complications
Measured: From transplant through end of follow up (at least 6 months year, up to 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.
- First posted24 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Durand, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665372
- Sponsor's protocol ID
- IRB00450882
- Other IDs
- U01AI138897, RTB-024
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT07665372
- Acronym / sponsor ID
- IRB00450882
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.
Detailed description
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.
Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV D+/R+ | Experimental | Other: HIV D+/R+People living with HIV who receive livers from deceased donors with HIV |
| HIV D-/R+ | Experimental | Other: HIV D-/R+People living with HIV who receive livers from deceased donors without HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 HIV-1 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 Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
Key exclusion criteria (3 listed)
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month duration, or prior primary Central Nervous System (CNS) lymphoma.
- Participant is pregnant or breastfeeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV D+/R+Receipt of liver transplant from a deceased donor with HIV | Other | HIV D+/R+ |
| HIV D-/R+Receipt of liver transplant from a deceased donor without HIV | Other | HIV D-/R+ |
Primary outcome
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Cumulative incidence of composite event of opportunistic infection or cancer
10 secondary outcomes
Participant survival
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft survival
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence and type of post-transplant cancer as determined by local pathology
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Serious adverse events post-transplant
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of rejection events post-transplant
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of surgical and vascular transplant complications during the first year post-transplant
Time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Durand, MD principal investigator
Johns Hopkins University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV D+/R+ and HIV D-/R+ in people with HIV, run by Johns Hopkins University at 19 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 5 inclusion and 3 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Contact Christine Durand, MD (410-614-6702, ChristineDurand@jhmi.edu), or a site near the patient. 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 HIV D+/R+ compared to HIV D-/R+ LT (time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.