HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Purpose
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
Condition
- Hiv
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant meets the standard criteria for liver transplant at the local center. - Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs. - Participant is able to understand and provide informed consent. - Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria. - Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).* - Participant is ≥ 18 years old. - Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible. - CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present. - HIV-1 RNA is below 50 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 anti-retroviral 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. - Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management. - Participant is willing to comply with all medications related to participant's transplant and HIV management. - For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease. - Agreement to use contraception. - Participant is not suffering from significant wasting (e.g. body mass index < 21) thought to be related to HIV disease.
Exclusion Criteria
- Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma.* - Participant is pregnant or breastfeeding. (Note: 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental HIV D+/R+ |
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40 |
|
No Intervention HIVD-/R+ |
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 |
|
No Intervention HIVD-/R+ (observational) |
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120 |
|
Recruiting Locations
University of Alabama, Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California, San Diego
San Diego, California 92103
San Diego, California 92103
University of California, San Francisco
San Francisco, California 94193
San Francisco, California 94193
Yale University School of Medicine
New Haven, Connecticut 06520-8022
New Haven, Connecticut 06520-8022
MedStar Georgetown Transplant Institute
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois at Chicago
Chicago, Illinois 60612
Chicago, Illinois 60612
Indiana University
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
University of Maryland, Institute of Human Virology
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Johns Hopkins University
Baltimore, Maryland 21205
Baltimore, Maryland 21205
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Weill Cornell Medical College
New York, New York 10065
New York, New York 10065
New York University School of Medicine
New York, New York 11016
New York, New York 11016
University of Cincinnati
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
UPMC - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
University of Tennessee Health and Science Center
Memphis, Tennessee 38104
Memphis, Tennessee 38104
University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
More Details
- NCT ID
- NCT03734393
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
Detailed Description
This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a liver from an HIV-uninfected deceased liver donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group