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

Hiv Clinical Trial

Official title:

HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263426
• Other study ID #: IRB00387066
• Secondary ID: U01AI177211
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: September 2029

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Christine Durand, MD
• Phone: 410-614-6702
• Email: cdurand2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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-).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• HIV D+/R+
Receipt of kidney transplant from a deceased donor with HIV.
• HIV D-/R+
Receipt of kidney transplant from a deceased donor without HIV.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of California, Los Angeles	Los Angeles	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	New York 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	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant survival	Time to event (death)	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Secondary	Graft survival	Time to event (graft loss)	From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Incidence of surgical and vascular transplant complications post-transplant	Cumulative incidence of complications	In the first year post-transplant
Secondary	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)
Secondary	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)
Secondary	Incidence of de novo donor specific antibody (DSA)	Based on central testing	At month 12 post-transplant