Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)

Not Applicable

Recruiting

• Conditions: Hiv
• Interventions: Other: HIV D+/R+; Other: HIV D-/R+

• Registration Number: NCT06263426
• Lead Sponsor: Johns Hopkins University

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-).

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-16
• Study Start: 2024-05-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2028-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.
• Cluster of differentiation 4 (CD4+) T-cell count: ≥ 200/μL within 16 weeks of transplant.
• 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.
• Participant meets with an independent advocate.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV D+/R+	HIV D+/R+	People living with HIV who receive kidneys from deceased donors with HIV
HIV D-/R+	HIV D-/R+	People living with HIV who receive kidneys from deceased donors without HIV

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of death and allograft rejection.	From date of transplant to end of year 1	Proportion of participants who die or have graft rejection

Secondary Outcome Measures

Name	Time	Method
Type and severity of graft rejection	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019)
Participant survival	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Time to event (death)
Rate of rejection events over time	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Count of rejection events
Graft function over time measured by eGFR trajectory	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Estimated glomerular filtration rate, calculated centrally based on local testing results
Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Cumulative incidence of infections
Time to first rejection	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Time to event (first rejection)
Incidence of de novo donor specific antibody (DSA)	At month 12 post-transplant	Based on central testing
Graft survival	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Time to event (graft loss)
Incidence of HIV viremia post-transplant	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Cumulative incidence of HIV viremia based on local testing
Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
Incidence of surgical and vascular transplant complications post-transplant	In the first year post-transplant	Cumulative incidence of complications
Incidence of post-transplant malignancies	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Cumulative incidence of malignancies
Incidence and causes of chronic kidney disease post-transplant	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)	Cumulative incidence of chronic kidney disease (eGFR\<60 for more than 3 months)

Trial Locations

Locations (13)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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