Clinical trial NCT06263426: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
Official title: HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.

Detailed description: 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-).

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of death and allograft rejection.
timeFrame: From date of transplant to end of year 1
Secondary outcomes:
measure: Participant survival
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Graft survival
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Type and severity of graft rejection
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Time to first rejection
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Rate of rejection events over time
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Graft function over time measured by eGFR trajectory
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of HIV viremia post-transplant
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of surgical and vascular transplant complications post-transplant
timeFrame: In the first year post-transplant
measure: Incidence and causes of chronic kidney disease post-transplant
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of post-transplant malignancies
timeFrame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
measure: Incidence of de novo donor specific antibody (DSA)
timeFrame: At month 12 post-transplant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Christine Durand, MD
role: PRINCIPAL_INVESTIGATOR
References: