What this study is
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.
What's being tested
- HIV D+/R+
Intervention · OTHER
Receipt of liver transplant from a deceased donor with HIV
- HIV D-/R+
Intervention · OTHER
Receipt of liver transplant from a deceased donor without HIV
Study details
- Official title
- HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
- Sponsor
- Johns Hopkins University
- Conditions
- HIV
- Enrolling
- 80 people
- Starts
- 2026-11
- Est. completion
- 2031-08
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (19)
19 openMayo Clinic, Arizona
Phoenix, Arizona, United States
- Andrew Singer, MD, PhD · ContactSinger.Andrew@mayo.edu
- Andrew Singer, MD, PhD · Principal investigator
Not yet recruitingCedars-Sinai Medical Center
Los Angeles, California, United States
- Nicholas Nissen, MD · ContactNicholas.Nissen@cshs.org
- Nicholas Nissen, MD · Principal investigator
Not yet recruitingUniversity of California, San Francisco
San Francisco, California, United States
- Jennifer Price, MD · ContactJennifer.Price@ucsf.edu
- Jennifer Price, MD · Principal investigator
Not yet recruitingUniversity of Colorado Anschutz
Aurora, Colorado, United States
- Chia-Yu Chiu, MD · Contactchia-yu.chiu@cuanschutz.edu
- Chia-Yu Chiu, MD · Principal investigator
Not yet recruitingMayo Clinic, Florida
Jacksonville, Florida, United States
- Shennen Mao, MD · ContactMao.Shennen@mayo.edu
- Shennen Mao, MD · Principal investigator
Not yet recruitingUniversity of Miami, Miami Transplant Institute
Miami, Florida, United States
- Jacques Simkins-Cohen, MD · Contactjsimkins@med.miami.edu
- Jacques Simkins-Cohen, MD · Principal investigator
Not yet recruitingEmory University
Atlanta, Georgia, United States
- William Kitchens, MD, PhD · Contactwilliam.henry.kitchens.jr@emory.edu
- William Kitchens, MD, PhD · Principal investigator
Not yet recruitingNorthwestern University
Chicago, Illinois, United States
- Valentina Stosor, MD · Contactv-stosor@northwestern.edu
- Valentina Stosor, MD · Principal investigator
Not yet recruitingOchsner Clinic Foundation
Jefferson, Louisiana, United States
- Jonathan Hand, MD · Contactjonathan.hand@ochsner.org
- Jonathan Hand, MD · Principal investigator
Not yet recruitingJohns Hopkins University
Baltimore, Maryland, United States
- Christine Durand, MD · ContactChristineDurand@jhmi.edu
- Christine Durand, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Nahel Elias, MD · ContactElias.Nahel@mgh.harvard.edu
- Nahel Elias, MD · Principal investigator
Not yet recruitingNew York University School of Medicine
New York, New York, United States
- Sapna Mehta, MD · ContactSapna.Mehta@nyulangone.org
- Sapna Mehta, MD · Principal investigator
Not yet recruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Sander Florman, MD · Contact
- Sander Florman, MD · Principal investigator
RecruitingWeill Cornell Medical College
New York, New York, United States
- Catherine B Small, MD · Contactcbs9003@med.cornell.edu
- Catherine B Small, MD · Principal investigator
Not yet recruitingUniversity of Cincinnati
Cincinnati, Ohio, United States
- Senu Apewokin, MD · Contactapewoksu@ucmail.uc.edu
- Senu Apewokin, MD · Principal investigator
Not yet recruitingOhio State University Medical Center
Columbus, Ohio, United States
- Nicholas Marschalk, DO · ContactNicholas.Marschalk@osumc.edu
- Nicholas Marschalk, DO · Principal investigator
Not yet recruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
- Ghady Haidar, MD · Contacthaidarg@upmc.edu
- Ghady Haidar, MD · Principal investigator
Not yet recruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
- David Wojciechowski, DO · ContactDavid.Wojciechowski@UTSouthwestern.edu
- David Wojciechowski, DO · Principal investigator
Not yet recruitingHouston Methodist Research Institute
Houston, Texas, United States
- Masayuki Nigo, MD MSc · Contactmnigo@houstonmethodist.org
- Masayuki Nigo, MD, MSc · Principal investigator
Not yet recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00450882
Principal investigator
Christine Durand, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.