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Procedure

HIV+ Liver Transplant for HIV Patients

N/A

Waitlist Available

Led By Christine Durand, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease

Participant meets the standard criteria for liver transplant at the local center

Must not have

Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an HIV-infected donor liver is safe for transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks include those associated with organ transplantation such as infection risk increase due to immunosuppression, potential rejection of the donor organ, and complications from managing two chronic conditions: post-transplant recovery and ongoing HIV treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am willing to follow all medication guidelines for my transplant and HIV treatment.

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I understand the study and can give my consent.

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I am 18 years old or older.

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My weight is healthy and not affected by HIV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had progressive multifocal leukoencephalopathy or primary CNS lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure

Secondary study objectives

1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only

1-year acute liver rejection

2-year acute liver rejection

+36 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: HIV D+/R+Experimental Treatment1 Intervention

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

Group II: HIVD-/R+Active Control1 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 Control1 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

0 / 7Eligibility criteria met