HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
NCT ID: NCT03500315
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2018-04-19
2024-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HIV D+/R+
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100
HIV D+/R+
Kidney from an HIV-infected deceased donor
HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100
No interventions assigned to this group
HIV D-/R+ (observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200
No interventions assigned to this group
Interventions
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HIV D+/R+
Kidney from an HIV-infected deceased donor
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Christine Durand, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
MedStar Georgetown Transplant Institute
Washington D.C., District of Columbia, United States
Miami Transplant Institute
Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York University School of Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Drexel University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC-University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Methodist Health System Clinical Research Institute
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Durand CM, Massie A, Florman S, Liang T, Rana MM, Friedman-Moraco R, Gilbert A, Stock P, Mehta SA, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Aslam S, Malinis M, Haidar G, Small CB, Santos CAQ, Schaenman J, Baddley J, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Brown D, Ostrander D, Eby Y, Desai N, Naqvi F, Bagnasco S, Watson N, Brittain E, Odim J, Redd AD, Tobian AAR, Segev DL; HOPE in Action Investigators. Safety of Kidney Transplantation from Donors with HIV. N Engl J Med. 2024 Oct 17;391(15):1390-1401. doi: 10.1056/NEJMoa2403733.
Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS, Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG, Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G, Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M, Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action Investigators. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States. Clin Infect Dis. 2022 Jun 10;74(11):2010-2019. doi: 10.1093/cid/ciab743.
Other Identifiers
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IRB00141138
Identifier Type: -
Identifier Source: org_study_id
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