HIV+ Liver Transplant for HIV Patients

Not currently recruiting at 26 trial locations

Overseen By Christine Durand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Antiretrovirals

Disqualifiers: PML, CNS lymphoma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety of liver transplants from HIV-positive donors for HIV-positive patients. It will compare outcomes between patients receiving livers from HIV-positive donors and those receiving livers from HIV-negative donors. HIV-positive individuals who are eligible for a liver transplant, free from major infections, and able to manage their HIV with medication might be suitable candidates. The trial focuses on minimizing transplant-related complications and effectively managing HIV. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could expand donor options for HIV-positive patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to comply with all medications related to your transplant and HIV management.

What prior data suggests that an HIV-infected donor liver transplant is safe for HIV patients?

Studies have shown that liver transplants using organs from HIV-positive donors are generally safe. Research indicates that the survival rates for these transplanted livers match those from HIV-negative donors. New evidence suggests that the risk of complications, such as acquiring another strain of HIV or infections from the donor, remains low.

Reports indicate that recipients of these transplants fare well over the long term, with favorable survival rates for both patients and their new livers. Although concerns about rejection and HIV-related issues exist, the overall safety appears promising. Thus, while risks are present, they are considered manageable, making this a viable option for some HIV-positive individuals in need of a liver transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using HIV-infected donor livers for transplantation into HIV-positive recipients. Unlike standard liver transplants, which typically use organs from HIV-negative donors, this approach could expand the donor pool significantly. By using organs from HIV-positive donors (HIV D+/R+), the trial aims to determine if outcomes are comparable to those with HIV-negative donors while maintaining the health of recipients. This could be a game-changer for HIV-positive patients needing liver transplants, reducing wait times and saving more lives.

What evidence suggests that this trial's treatments could be effective for HIV+ liver transplant patients?

This trial will compare liver transplants from HIV-positive donors to HIV-positive recipients (HIVD+/R+) with transplants from HIV-negative donors to HIV-positive recipients. Research has shown that liver transplants from HIV-positive donors to HIV-positive recipients (HIVD+/R+) are promising. One study found a relatively low rejection rate of 18%, with only one case leading to transplant failure. Outcomes did not significantly differ between HIV-positive and HIV-negative donors. Early studies highlight excellent results for HIVD+/R+ transplants, supporting their safety and effectiveness. Long-term outcomes for people with HIV are similar to those without HIV, suggesting that liver transplants in HIV-positive individuals work well. Overall, this evidence suggests that HIVD+/R+ liver transplants can be a viable and effective option. ^{1 4 6 7 8}

Who Is on the Research Team?

Christine Durand, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who need a liver transplant and meet standard criteria, including managing their HIV effectively (low viral load) and having no active opportunistic infections. They must understand the study, agree to follow treatment plans, use contraception, and not be significantly underweight due to HIV.

Inclusion Criteria

I am eligible for both a liver and kidney transplant.

I have had aspergillus before but currently show no signs of it.

I meet the requirements for a liver transplant according to my local hospital.

Exclusion Criteria

Participant is pregnant or breastfeeding. Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed

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

I have had progressive multifocal leukoencephalopathy or primary CNS lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants receive a liver transplant from either an HIV-infected or HIV-uninfected deceased donor

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after transplant, including monitoring for HIV breakthroughs and graft function

4 years

Observational Follow-up

Participants in the observational group are followed with limited data collection

4 years

What Are the Treatments Tested in This Trial?

Interventions

• HIVD+/R+

Trial Overview The HOPE in Action Trial is testing the safety of liver transplants from deceased donors with HIV to recipients with HIV. It focuses on major complications related to both the transplant procedure and management of HIV post-transplant.

How Is the Trial Designed?

Group I: HIV D+/R+ Experimental Treatment 1 Intervention

HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40

Group II: HIVD-/R+ Active Control 1 Intervention

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and are randomized to participate in the full study arm, which includes research sample collection -enrollment 40

Group III: HIVD-/R+ (observational) Active Control 1 Intervention

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

HIV-infected patients with end-stage liver disease (ESLD) have a one-year survival rate of only 50-55%, but liver transplantation is now a viable option for these patients, with mid-term survival rates similar to those of HIV-negative patients.

Post-transplant challenges include interactions between antiretroviral and immunosuppressive medications, as well as the recurrence of hepatitis C virus (HCV) infection, which significantly impacts survival, especially in HIV-HCV co-infected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation in HIV/hepatitis co-infection. Miro, JM., Aguero, F., Laguno, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9997133/

HOPE in Action: A Prospective Multicenter Pilot Study of Liver ... Rejection occurred in 18% of recipients, with only 1 rejection-related graft failure and no difference in D+ vs D− recipients. The relatively low rejection rate ...

2. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-transplantation

Special Populations: Transplantation in People with HIV | NIH Early studies have shown excellent outcomes of HIV D+/R+ kidney and liver transplantation.64,67 Based on this, the federal Advisory ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1600613525000905

Successful outcomes of hepatitis C virus D+/R− transplants ... Graft survival was 96% at 1 and 3 years. HCV D+/R− abdominal transplantation, including donors with HCV/HIV coinfection, demonstrates favorable patient and ...

4. myast.org myast.org/uploads/files/general/Ch.-10-HIV-and-Solid-Organ-Transplant-2025.pdf

10. HIV and Solid Organ Transplant 10.1 Kidney/pancreas ... Long term outcomes between HIV+ and HIV- recipients were similar and support liver transplant in people with HIV. Benner SE, Zhu Z, Hussain S et al. (2023). ...

5. mdpi.com mdpi.com/2075-1729/13/10/1975

Liver Transplantation in People Living with HIV 7. Conclusions. Liver transplantation in people living with HIV is associated with comparable outcomes to HIV-uninfected LT recipients in terms of graft and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803374/

HIV+ Deceased Donor Referrals: A National Survey ... Outcomes with organ transplantation among HIV+ recipients (HIV R+) are excellent5–11 however mortality on the waitlist is disproportionately higher in HIV+ ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1198743X25004239

Current situation of solid organ transplantation from HIV ... Emerging evidence supports the safety of HIV D+ organs, with graft survival rates comparable with HIV D− transplants and minimal risk of HIV ...

8. federalregister.gov federalregister.gov/documents/2024/11/27/2024-27410/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-hope-act

Implementation of the HIV Organ Policy Equity (HOPE) Act The primary outcome assessed was a safety outcome (a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough ...