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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hiv
• Intervention / Treatment: Other: HIV D+/R+; Other: HIV D-/R+

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Durand, MD; Phone Number: 410-614-6702; Email: cdurand2@jhmi.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Principal Investigator: Shikha Mehta, MD
      • Contact: Shikha Mehta, MD; Email: smehta@uabmc.edu
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
      • Contact: Joanna Schaenman, MD, PhD; Email: JSchaenman@mednet.ucla.edu
      • Principal Investigator: Joanna Schaenman, MD, PhD
    • San Diego, California, United States, 92037
      • University of California, San Diego
      • Principal Investigator: Saima Aslam, MBBS
      • Contact: Saima Aslam, MBBS; Email: saslam@ucsd.edu
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Principal Investigator: Garrett Roll, MD
      • Contact: Garrett Roll, MD; Email: Garrett.Roll@ucsf.edu
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
      • Principal Investigator: Maricar Malinis, MD
      • Contact: Maricar Malinis, MD; Email: maricar.malinis@yale.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
      • Contact: Carlos Santos, MD; Email: Carlos_A_Santos@rush.edu
      • Principal Investigator: Carlos Santos, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
      • Contact: Jonathan Hand, MD; Email: jonathan.hand@ochsner.org
      • Principal Investigator: Jonathan Hand, MD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
      • Principal Investigator: Christine Durand, MD
      • Contact: Christine Durand, MD; Email: cdurand2@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Principal Investigator: Nahel Elias, MD
      • Contact: Nahel Elias, MD; Email: elias.nahel@mgh.harvard.edu
  • New York
    • New York, New York, United States, 10032
      • Columbia University
      • Principal Investigator: Marcus Pereira, MD
      • Contact: Marcus Pereira, MD
    • New York, New York, United States, 10016
      • New York University
      • Principal Investigator: Sapna Mehta, MD
      • Contact: Sapna Mehta, MD; Email: Sapna.mehta@nyumc.org
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
      • Contact: Catherine Small, MD; Email: Cbs9003@med.cornell.edu
      • Principal Investigator: Catherine Small, MD
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
      • Principal Investigator: Sander Florman, MD
      • Contact: Sander Florman, MD; Email: Sander.florman@mountsinai.org
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
      • Principal Investigator: Ghady Haidar, MD
      • Contact: Ghady Haidar, MD; Email: haidarg@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV D+/R+; People living with HIV who receive kidneys from deceased donors with HIV	Other: HIV D+/R+; Receipt of kidney transplant from a deceased donor with HIV.
Experimental: HIV D-/R+; People living with HIV who receive kidneys from deceased donors without HIV	Other: HIV D-/R+; Receipt of kidney transplant from a deceased donor without HIV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of death and allograft rejection.	Proportion of participants who die or have graft rejection	From date of transplant to end of year 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Christine Durand, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00387066; U01AI177211 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No