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| ID | Type | Description | Link |
|---|---|---|---|
| JHUHIVDD | Other Identifier | Site Specific Identifier | |
| 1U01AI134591-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Yale University | OTHER |
| Georgetown University | OTHER |
| Emory University |
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HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.
This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV D+/R+ | HIV-infected individuals who accept an organ from an HIV-infected deceased donor |
| |
| HIV D-/R+ | HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-infected deceased donor organ | Other | HIV-infected deceased donor organ transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Patient survival at one year | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Graft survival | Transplanted organ function | one year, two years, 3 years, 4 years |
| Graft rejection | Incidence and severity of organ rejection |
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Inclusion Criteria:
All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
Exclusion Criteria:
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All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Christine Durand, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41524130 | Derived | Arant EC, Davy-Mendez T, Liang T, Rodrigues M, Gay CL, 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 JW, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Morsheimer M, van Delden C, Manuel O, Mueller NJ, Neofyotos D, Tobian AAR, Massie A, Segev DL, Werbel W, Durand CM. Infections After Kidney Transplantation From Donors With HIV to Recipients With HIV. Clin Infect Dis. 2026 Mar 17;82(3):e549-e557. doi: 10.1093/cid/ciaf656. | |
| 37379584 |
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| 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 |
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Plasma, serum, peripheral blood mononuclear cells, tissue
| One year |
| HIV disease progression | Incidence of virologic breakthrough or failure | through study completion, up to 4 years |
| Antiretroviral resistance and X4 tropic virus | incidence of new antiretroviral drug resistance and/or X4 tropic virus | through study completion, up to 4 years |
| Incidence of bacterial, fungal, viral, and other opportunistic infection | incidence of bacterial, fungal, viral, and other opportunistic infections | through study completion, up to 4 years |
| Surgical complications | incidence of surgical and vascular transplant complications | within the first 3 months |
| Recurrent HIV-associated nephropathy | incidence of recurrent HIV-associated nephropathy in kidney recipients | through study completion, up to 4 years |
| Incidence of post-transplant Malignancy | incidence of post-transplant malignancies | through study completion, up to 4 years |
| Incidence of HIV superinfection in blood and/or tissue | Incidence of HIV superinfection in blood and/or tissue | measured at 3 months, 6 months, year 1, year 2, year 3, year 4 |
| HIV latent reservoir | Frequency of infected CD4 T cells in blood | measured at 3 months, 6 months, year 1, year 2, year 3, year 4 |
| Immune activation | Cytokine levels | measured at 3 months, 6 months, year 1, year 2, year 3, year 4 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Maryland, Institute of Human Virology | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Methodist Health System | Dallas | Texas | 75203 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Derived |
| 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. |
| 34453519 | Derived | 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. |
| 32730756 | Derived | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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