RECRUITINGINTERVENTIONAL
Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
About This Trial
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Who May Be Eligible (Plain English)
Who May Qualify:
- Participant meets local criteria for kidney transplant.
- Participant is able to understand and provide willing to sign a consent form.
- Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
- Participant is ≥ 18 years old.
- HIV-1 RNA \< 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL.
- Participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to HIV disease.
Who Should NOT Join This Trial:
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month, or primary central nervous system (CNS) lymphoma.
- 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 from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Participant meets local criteria for kidney transplant.
* Participant is able to understand and provide informed consent.
* Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
* Participant is ≥ 18 years old.
* HIV-1 RNA \< 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL.
* Participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to HIV disease.
Exclusion Criteria:
* Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month, or primary central nervous system (CNS) lymphoma.
* 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 from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Treatments Being Tested
OTHER
HIV D+/R+
Receipt of kidney transplant from a deceased donor with HIV.
OTHER
HIV D-/R+
Receipt of kidney transplant from a deceased donor without HIV.
Locations (13)
University of Alabama at Birmingham
Birmingham, Alabama, 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
Rush University Medical Center
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York University
New York, New York, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States