HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:January 4, 2019
End Date:June 30, 2024
Contact:Christine Durand, MD
Email:cdurand2@jhmi.edu
Phone:410-955-5684

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HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

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

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

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.
We found this trial at
19
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jared White, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Valentina Stosor, MD
Phone: 312-695-5085
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Christine Durand, MD
Phone: 410-955-5684
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Nahel Elias, MD
Phone: 617-726-0174
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Boston, MA
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Michele Morris, MD
Phone: 305-243-4598
University of Miami A private research university with more than 15,000 students from around the...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Timothy Pruett, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Baltimore, Maryland 21201
Principal Investigator: Jennifer Husson, MD
Phone: 410-706-8614
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Baltimore, MD
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Valentina Stosor, MD
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Carlos A. Santos, MD, MPHS
Phone: 312-563-6372
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Senu Apewokin, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Jonathan Hand, MD
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Sander Florman, MD
Phone: 212-659-8313
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Marcus Pereira, MD
Phone: 212-305-3839
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Sapna Mehta, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Emily Blumberg, MD
Phone: 215-662-7066
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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3459 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Ghady Haidar, MD
Phone: 412-648-6212
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San Diego, California 92093
Principal Investigator: Saima Aslam, MD
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San Diego, CA
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San Francisco, California 94143
Principal Investigator: Jennifer Price, MD
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Washington, District of Columbia 20007
Principal Investigator: Coleman Smith, MD
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Washington,
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