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

Last updated: June 5, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Treatment

HIV D-/R+

HIV D+/R+

Clinical Study ID

NCT06263426
IRB00387066
U01AI177211
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 historyof detectable HIV-1 RNA.

  • Participant is ≥ 18 years old.

  • Cluster of differentiation 4 (CD4+) T-cell count: ≥ 200/μL within 16 weeks oftransplant.

  • HIV-1 RNA < 50 copies/mL. Viral blips between 50-400 copies will be allowed as longas 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

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, physicalexamination or laboratory testing that are not listed above, which, in the opinionof the investigator, may pose additional risks from participation in the study, mayinterfere with the participant's ability to comply with study requirements or thatmay impact the quality or interpretation of the data obtained from the study.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: HIV D-/R+
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
September 30, 2029

Study 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-).

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, San Diego

    San Diego, California 92037
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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