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NCT06263426NARecruiting

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

Johns Hopkins University

Start Date

5/22/2024

Completion Date

9/1/2029

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

Age Range: 18 years to No maximum

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.

Interventions

OTHER

HIV D+/R+

OTHER

HIV D-/R+

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Conditions

Hiv

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

University of California, Davis

Sacramento, California 95817

United States

University of California, San Diego

San Diego, California 92037

United States

University of California, San Francisco

San Francisco, California 94143

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

Northwestern University

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

Johns Hopkins University

Baltimore, Maryland 21205

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Washington University St. Louis Barnes Jewish Hospital

St Louis, Missouri 63110

United States

New York University

New York, New York 10016

United States

Icahn School of Medicine at Mt. Sinai

New York, New York 10029

United States

Columbia University

New York, New York 10032

United States

Weill Cornell Medical Center

New York, New York 10065

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Houston Methodist Research Institute

Houston, Texas 77030

United States