HIV+ Liver Transplant for HIV Patients

Recruiting at 25 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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the HIV+ liver transplant treatment for HIV patients?

The study found that patient and graft survival rates for liver transplants from HIV-positive donors to HIV-positive recipients were better than historical data, with a 1-year survival rate of 83.3%. However, there was a potential increase in infections and cancer, which needs further investigation. ^{1 2 3 4 5}

Is liver transplantation from HIV-positive donors to HIV-positive recipients safe?

Liver transplants from HIV-positive donors to HIV-positive recipients have shown similar patient and graft survival rates compared to those from HIV-negative donors, but there may be a higher risk of infections and cancer. Careful monitoring and management of drug interactions are important for safety. ^{1 4 5 6 7}

How is the HIV+ liver transplant treatment different from other treatments for HIV patients?

This treatment is unique because it involves liver transplants from donors with HIV to recipients with HIV, which is not common practice. It is part of a pilot study under the HOPE Act, and while it shows promising survival rates, it may lead to more infections and cancer compared to transplants from non-HIV donors. ^{1 2 3 4 7}

What is the purpose of this trial?

The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications

Research Team

Christine Durand, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term Outcomes After Liver Transplantation Among Human Immunodeficiency Virus-Infected Recipients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Liver transplantation in HIV/hepatitis co-infection. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation in HIV-infected recipients. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Beyond the NIH Multicenter HIV Transplant Trial Experience: Outcomes of HIV+ Liver Transplant Recipients Compared to HCV+ or HIV+/HCV+ Coinfected Recipients in the United States. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Hepatitis C virus-HIV-coinfected patients and liver transplantation. [2018]

7. Denmark pubmed.ncbi.nlm.nih.gov

Liver transplantation in HIV-positive patients. [2009]