Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
NCT ID: NCT02602262
Last Updated: 2025-08-14
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
105 participants
OBSERVATIONAL
2015-11-30
2023-06-16
Brief Summary
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Detailed Description
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In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV D+/R+
HIV-infected individuals who accept an organ from an HIV-infected deceased donor
HIV-infected deceased donor organ
HIV-infected deceased donor organ transplant
HIV D-/R+
HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor
No interventions assigned to this group
Interventions
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HIV-infected deceased donor organ
HIV-infected deceased donor organ transplant
Eligibility Criteria
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Exclusion Criteria
2. Participant meets standard listing criteria for transplant.
3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).
4. Participant is \> 18 years old.
5. Opportunistic Complications: None or previous history of protocol allowed opportunistic infections or neoplasms with appropriate acute and maintenance therapy and no evidence of active disease.
6. Participant CD4+ T-cell count is \>/= 200/µL in the 16 weeks prior to transplant.
7. Participant most recent HIV-1 RNA \< 50 copies/mL (by any FDA-approved assay performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL) should be \< 50 copies, but this result can be documented outside the 16 week window according to the judgement of the local clinical team and site investigator. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen to be used by the recipient once organ function is restored after transplantation.
8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.
1. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
2. Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of \> 1 month duration, or primary Central Nervous System (CNS) lymphoma.
3. Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease free state for 2 years. History of leukemia and disease-free duration will be per site policy.
4. 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 clinical practice. Women that become pregnant should not breastfeed.
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Yale University
OTHER
Georgetown University
OTHER
Emory University
OTHER
Rush University Medical Center
OTHER
University of Illinois at Chicago
OTHER
Indiana University
OTHER
University of Maryland
OTHER
Columbia University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Weill Medical College of Cornell University
OTHER
University of Pittsburgh Medical Center
OTHER
Methodist Health System
OTHER
Northwestern University
OTHER
NYU Langone Health
OTHER
University of Virginia
OTHER
Washington University School of Medicine
OTHER
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 Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 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
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, 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 Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Methodist Health System
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Benner SE, Zhu X, Hussain S, Florman S, Eby Y, Fernandez RE, Ostrander D, Rana M, Ottmann S, Hand J, Price JC, Pereira MR, Wojciechowski D, Simkins J, Stosor V, Mehta SA, Aslam S, Malinis M, Haidar G, Massie A, Smith ML, Odim J, Morsheimer M, Quinn TC, Laird GM, Siliciano R, Balagopal A, Segev DL, Durand CM, Redd AD, Tobian AAR. HIV-Positive Liver Transplant Does not Alter the Latent Viral Reservoir in Recipients With Antiretroviral Therapy-Suppressed HIV. J Infect Dis. 2023 Nov 2;228(9):1274-1279. doi: 10.1093/infdis/jiad241.
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.
Bonny TS, Kirby C, Martens C, Rose R, Desai N, Seisa M, Petropoulos C, Florman S, Friedman-Moraco RJ, Turgeon NA, Brown D, Segev DL, Durand CM, Tobian AAR, Redd AD. Outcomes of donor-derived superinfection screening in HIV-positive to HIV-positive kidney and liver transplantation: a multicentre, prospective, observational study. Lancet HIV. 2020 Sep;7(9):e611-e619. doi: 10.1016/S2352-3018(20)30200-9. Epub 2020 Jul 27.
Other Identifiers
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JHUHIVDD
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00085148
Identifier Type: -
Identifier Source: org_study_id
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