protocolSection identificationModule nctId: NCT06263426, orgStudyIdInfo id: IRB00387066, secondaryIdInfos id: U01AI177211, type: NIH, link: https://reporter.nih.gov/quickSearch/U01AI177211, briefTitle: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV., conditionsModule conditions: Hiv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HIV D+/R+, interventions name: HIV D-/R+, outcomesModule primaryOutcomes measure: Cumulative incidence of death and allograft rejection., secondaryOutcomes measure: Participant survival, secondaryOutcomes measure: Graft survival, secondaryOutcomes measure: Type and severity of graft rejection, secondaryOutcomes measure: Time to first rejection, secondaryOutcomes measure: Rate of rejection events over time, secondaryOutcomes measure: Graft function over time measured by eGFR trajectory, secondaryOutcomes measure: Incidence of HIV viremia post-transplant, secondaryOutcomes measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant, secondaryOutcomes measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant, secondaryOutcomes measure: Incidence of surgical and vascular transplant complications post-transplant, secondaryOutcomes measure: Incidence and causes of chronic kidney disease post-transplant, secondaryOutcomes measure: Incidence of post-transplant malignancies, secondaryOutcomes measure: Incidence of de novo donor specific antibody (DSA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Shikha Mehta, MD, role: CONTACT, email: smehta@uabmc.edu, contacts name: Shikha Mehta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: University of California, Los Angeles, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Joanna Schaenman, MD, PhD, role: CONTACT, email: JSchaenman@mednet.ucla.edu, contacts name: Joanna Schaenman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California, San Diego, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Saima Aslam, MBBS, role: CONTACT, email: saslam@ucsd.edu, contacts name: Saima Aslam, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Garrett Roll, MD, role: CONTACT, email: Garrett.Roll@ucsf.edu, contacts name: Garrett Roll, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Yale School of Medicine, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Maricar Malinis, MD, role: CONTACT, email: maricar.malinis@yale.edu, contacts name: Maricar Malinis, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Rush University Medical Center, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Carlos Santos, MD, role: CONTACT, email: Carlos_A_Santos@rush.edu, contacts name: Carlos Santos, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Ochsner Clinic Foundation, city: New Orleans, state: Louisiana, zip: 70121, country: United States, contacts name: Jonathan Hand, MD, role: CONTACT, email: jonathan.hand@ochsner.org, contacts name: Jonathan Hand, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Christine Durand, MD, role: CONTACT, email: cdurand2@jhmi.edu, contacts name: Christine Durand, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Nahel Elias, MD, role: CONTACT, email: elias.nahel@mgh.harvard.edu, contacts name: Nahel Elias, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: New York University, city: New York, state: New York, zip: 10016, country: United States, contacts name: Sapna Mehta, MD, role: CONTACT, email: Sapna.mehta@nyumc.org, contacts name: Sapna Mehta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Icahn School of Medicine at Mt. Sinai, city: New York, state: New York, zip: 10029, country: United States, contacts name: Sander Florman, MD, role: CONTACT, email: Sander.florman@mountsinai.org, contacts name: Sander Florman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University, city: New York, state: New York, zip: 10032, country: United States, contacts name: Marcus Pereira, MD, role: CONTACT, contacts name: Marcus Pereira, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Weill Cornell Medical Center, city: New York, state: New York, zip: 10065, country: United States, contacts name: Catherine Small, MD, role: CONTACT, email: Cbs9003@med.cornell.edu, contacts name: Catherine Small, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Ghady Haidar, MD, role: CONTACT, email: haidarg@upmc.edu, contacts name: Ghady Haidar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False