Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
Recruiting · NCT06263426 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
HIV D+/R+
What this trial is about
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
18 locations listed across 11 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of California, Davis - Sacramento, California, United States
- University of California, San Diego - San Diego, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Northwestern University - Chicago, Illinois, 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
- Washington University St. Louis Barnes Jewish Hospital - St Louis, Missouri, 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 Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Houston Methodist Research Institute - Houston, Texas, United States