RecruitingNot ApplicableNCT06263426
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
Sponsor
Johns Hopkins University
Enrollment
200 participants
Start Date
May 22, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria3
- 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.
Interventions
OTHERHIV D+/R+
Receipt of kidney transplant from a deceased donor with HIV.
OTHERHIV D-/R+
Receipt of kidney transplant from a deceased donor without HIV.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06263426
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