Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01AI177211 | 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
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.
Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of their HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of their HIV. This study will look to better understand rejection in transplant recipients with HIV (HIVR+) who receive kidneys from donors with HIV (HIVD+) vs without HIV (HIVD-).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV D+/R+ | Experimental | People living with HIV who receive kidneys from deceased donors with HIV |
|
| HIV D-/R+ | Experimental | People living with HIV who receive kidneys from deceased donors without HIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV D+/R+ | Other | Receipt of kidney transplant from a deceased donor with HIV. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of death and allograft rejection. | Proportion of participants who die or have graft rejection | From date of transplant to end of year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant survival | Time to event (death) | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Graft survival | Time to event (graft loss) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Durand, MD | Contact | 410-614-6702 | cdurand2@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christine Durand, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HIV D-/R+ |
| Other |
Receipt of kidney transplant from a deceased donor without HIV. |
|
| From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Type and severity of graft rejection | Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019) | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Time to first rejection | Time to event (first rejection) | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Rate of rejection events over time | Count of rejection events | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Graft function over time measured by eGFR trajectory | Estimated glomerular filtration rate, calculated centrally based on local testing results | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of HIV viremia post-transplant | Cumulative incidence of HIV viremia based on local testing | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant | Cumulative incidence of new resistance and/or X4 tropic virus based on local testing | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant | Cumulative incidence of infections | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of surgical and vascular transplant complications post-transplant | Cumulative incidence of complications | In the first year post-transplant |
| Incidence and causes of chronic kidney disease post-transplant | Cumulative incidence of chronic kidney disease (eGFR<60 for more than 3 months) | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of post-transplant malignancies | Cumulative incidence of malignancies | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) |
| Incidence of de novo donor specific antibody (DSA) | Based on central testing | At month 12 post-transplant |
| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
|
| University of California, San Diego | Recruiting | San Diego | California | 92037 | United States |
|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Washington University St. Louis Barnes Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
|
| New York University | Recruiting | New York | New York | 10016 | United States |
|
| Icahn School of Medicine at Mt. Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Columbia University | Recruiting | New York | New York | 10032 | United States |
|
| Weill Cornell Medical Center | Not yet recruiting | New York | New York | 10065 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| 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