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Procedure
HIV+ Liver Transplant for HIV Patients
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years post-transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am willing to follow all medication guidelines for my transplant and HIV treatment.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure
Secondary outcome measures
1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only
1-year acute liver rejection
2-year acute liver rejection
+36 moreTrial 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
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,690 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,266 Previous Clinical Trials
5,484,017 Total Patients Enrolled
Christine Durand, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
716 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am willing to follow all medication guidelines for my transplant and HIV treatment.My HIV viral load is under control, or I have a plan for ART after an organ transplant.I have had progressive multifocal leukoencephalopathy or primary CNS lymphoma.I understand the study and can give my consent.I am 18 years old or older.My weight is healthy and not affected by HIV.
Research Study Groups:
This trial has the following groups:- Group 1: HIV D+/R+
- Group 2: HIVD-/R+
- Group 3: HIVD-/R+ (observational)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently available to participants?
"Clinicaltrials.gov notes that this research trial is presently seeking candidates, with the original post date on April 1st 2019 and the most recent update being recorded May 4th 2022."
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