Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01AI134591 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV D+/R+ | Experimental | HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100 |
|
| HIV D-/R+ | No Intervention | HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100 | |
| HIV D-/R+ (observational) | No Intervention | HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV D+/R+ | Other | Kidney from an HIV-infected deceased donor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection | Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection | From date of transplant through administrative censorship at study completion, up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-transplant mortality | Time to mortality while enrolled before transplant (survival framework) | From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years |
| Graft failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Durand, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41823991 | Derived | Sulaiman A, Tamil Selvan M, Yang P, Zhu X, Eby Y, Benner SE, Fernandez RE, Hussain S, Brown D, Desai N, Florman S, Rana MM, Friedman-Moraco R, Pereira MR, Mehta S, Stock P, Gilbert A, Morris MI, Stosor V, Mehta SA, Small CB, Ranganna K, Santos CAQ, Aslam S, Malinis M, Elias N, Blumberg EA, Massie A, Smith ML, Morsheimer M, Laird GM, Siliciano R, Segev DL, Durand CM, Redd AD, Tobian AA. Allograft Rejection and the Latent HIV Reservoir in Kidney Transplant Recipients with HIV. J Infect Dis. 2026 Mar 13:jiag154. doi: 10.1093/infdis/jiag154. Online ahead of print. | |
| 41817597 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Time to mortality or re-transplant or return to maintenance dialysis (survival framework)
| From date of transplant through administrative censorship at study completion, up to 4 years |
| Rate of serious adverse events | Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 | From date of transplant through graft failure or administrative censorship at study completion, up to year 4 |
| 6-month acute rejection | Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3) | From date of transplant to end of month 6 |
| 1-year acute rejection | Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3) | From date of transplant to end of year 1 |
| Incidence of graft rejection | Cumulative incidence of acute rejection (survival framework) as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3) | From date of transplant through administrative censorship, up to 4 years |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 3 months post-transplant |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 6 months post-transplant |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 9 months post-transplant |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 1 year post-transplant |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 2 years post-transplant |
| Graft function - Proportion eGFR <60 mL/min/1.73 m2 | Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 | 3 years post-transplant |
| Graft function -mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 3 months post-transplant |
| Graft function-mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 6 months post-transplant |
| Graft function-mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 9 months post-transplant |
| Graft function-mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 1 year post-transplant |
| Graft function-mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 2 years post-transplant |
| Graft function-mean eGFR | Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) | 3 years post-transplant |
| Graft function - slope eGFR | The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis) | From date of transplant to end of follow-up, up to 4 years |
| Incidence of non-HIV renal disease | Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis | 6 months post-transplant |
| Incidence of non-HIV renal disease | Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis | 1 year post-transplant |
| Incidence of HIV-related renal disease | Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy | 6 months post-transplant |
| Incidence of HIV-related renal disease | Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy | 1 year post-transplant |
| Donor and recipient apolipoprotein L1 (APOL1) | Proportion of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient | Baseline |
| HIV infection of renal allografts | Proportion of recipients with HIV seen in laser capture microdissection of renal biopsy | 6 months post-transplant |
| Trajectory of recipient plasma HIV RNA over time | Analysis of repeated measures of plasma HIV RNA (longitudinal model) | From date of transplant through end of follow-up, up to 4 years |
| Trajectory of recipient Cluster of Differentiation (CD4) count over time | Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model) | From date of transplant through end of follow up, up to 4 years |
| Incidence of antiretroviral resistance | Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant | From date of transplant through end of follow-up, up to 4 years |
| Incidence of X4 tropic virus | Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant | From date of transplant through end of follow-up, up to 4 years |
| Incidence of opportunistic infection | Cumulative incidence of opportunistic infections | From date of transplant through end of follow-up, up to 4 years |
| Incidence of surgical complications | Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence | From date of transplant through year 1 |
| Incidence of vascular complications | Number of vascular complications within 1 year of transplant | From date of transplant through year 1 |
| Incidence of viral-related malignancies | Number of malignancies as determined by local pathology | From date of transplant through end of follow-up, up to 4 years |
| Incidence of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies | Proportion of participants with a de novo donor-specific HLA antibody as measured and reported by local sites' lab | From date of transplant through end of year 1 |
| Composite event, time to first | Time to first of any of these events: all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness | From date of transplant through end of follow-up, up to 4 years |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| University of California, San Francisco | San Francisco | California | 94193 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520-8022 | United States |
| MedStar Georgetown Transplant Institute | Washington D.C. | District of Columbia | 20007 | United States |
| Miami Transplant Institute | Miami | Florida | 33136 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | 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 |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| University of Maryland, Institute of Human Virology | Baltimore | Maryland | 212101 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | 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 Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC-University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Methodist Health System Clinical Research Institute | Dallas | Texas | 75203 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Derived |
| Zhu X, Morgenlander WR, Brown DM, Eby Y, Morsheimer M, Odim J, Bagnasco SM, Rana MM, Florman SS, Friedman-Moraco RJ, Stock PG, Gilbert AJ, Mehta S, Stosor V, Mehta SA, Pereira MR, Small CB, Morris MI, Hand J, Aslam S, Haidar G, Malinis M, Santos CA, Schaenman J, Wojciechowski D, Ranganna K, Blumberg E, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Grabowski MK, Segev DL, Redd AD, Durand CM, Larman HB, Tobian AA; HOPE in Action investigators. Human antibody repertoire among kidney donors with and without HIV. JCI Insight. 2026 Mar 12;11(8):e203645. doi: 10.1172/jci.insight.203645. eCollection 2026 Apr 22. |
| 41247466 | Derived | Freercks R, Rodrigues M, Manning K, Heymann J, Kopp JB, Nagiah S, Rana M, Florman S, Friedman-Moraco R, Stock P, Gilbert A, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Haidar G, Malinis M, Santos CAQ, Schaenman J, Blumberg EA, Wojciechowski D, Odim J, Massie A, Selvan MT, Bagnasco S, Segev D, Tobian AAR, Muller E, Durand CM, Redd AD. APOL1 Genotype and Patient Outcomes in US and South African Transplant Recipients With HIV who Received Kidneys From Donors With HIV. Transplantation. 2026 Apr 1;110(4):e897-e904. doi: 10.1097/TP.0000000000005556. Epub 2025 Nov 17. |
| 39413376 | Derived | 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. |
| 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. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided