HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:April 19, 2018
End Date:August 1, 2022
Contact:Christine Durand, MD
Email:cdurand2@jhmi.edu
Phone:410-955-5684

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

This study will evaluate if receiving a kidney transplant from an HIV-infected deceased
kidney donor is safe with regards to survival and major transplant-related and HIV-related
complications compared to receiving a kidney from an HIV-uninfected deceased kidney 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 kidney transplant at the local center.

- Participant is able to understand and provide informed consent.

- Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE)
Act Safeguards.

- Documented HIV infection (by any licensed assay, or documented history of detectable
HIV-1 RNA).

- No living donor available.

- Participant is ≥18 years old.

- Opportunistic complications: if prior history of an opportunistic infection, the
participant has received appropriate therapy and has no evidence of active disease.

- Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.

- HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as
there are not consecutive measurements >200 copies/mL.

- Participant is willing to comply with all medication related to their transplant and
HIV management.

- For participant with a history of aspergillus colonization or disease, no evidence of
active disease.

- The participant must have, or be willing to start seeing, a primary medical care
provider with expertise in HIV management.

- All participants participating in sexual activity that could lead to pregnancy must
use an FDA approved method of birth control.

- 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.

- 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 or may impact the quality or
interpretation of the data obtained from the study.
We found this trial at
23
sites
Los Angeles, California 90095
310-825-4321
Principal Investigator: Joanna Schaenman, MD, PhD
Phone: 310-825-7225
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Nicole Turgeon, MD
Phone: 404-727-3257
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: 410-614-0648
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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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Shikha Mehta, MD
Phone: 205-934-1801
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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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Wojciechowski, DO
Phone: 617-724-9673
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Cameron Wolfe, MD
Phone: 919-599-7252
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Baltimore, Maryland 21201
Principal Investigator: Jennifer Husson, MD, MPH
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
Phone: 312-695-5085
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Carlos 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, FACP
Phone: 513-558-4704
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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1801 NW 9th Ave
Miami, Florida 33136
Principal Investigator: Michele I. Morris, MD
Phone: 305-243-4598
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Miami, FL
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Maricar Malinis, MD
Phone: 203-785-2073
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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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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New York, New York 10065
Principal Investigator: Catherine Small, MD
Phone: 914-552-5960
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New York, NY
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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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New York, NY
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Sapna Mehta, MD
Phone: 646-754-1006
New York University School of Medicine NYU School of Medicine has a proud history that...
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Dong Heun Lee, MD
Phone: 215-762-4697
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Philadelphia, PA
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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 Aslan, MD
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San Diego, CA
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San Francisco, California 94143
Principal Investigator: Peter Stock, MD, PhD
Phone: 415-476-2575
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Washington, District of Columbia 20007
Principal Investigator: Alexander Gilbert, MD
Phone: 202-444-2072
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Washington,
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