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

NCT06263426 | Recruiting DMC

• 2 other identifiers: IRB00387066U01AI177211
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Participant survival

  From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

• Graft survival

  From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

• Type and severity of graft rejection

  From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

• Time to 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

  From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

Study Arms (2)

HIV D+/R+

EXPERIMENTAL

People living with HIV who receive kidneys from deceased donors with HIV

Other: HIV D+/R+

HIV D-/R+

EXPERIMENTAL

People living with HIV who receive kidneys from deceased donors without HIV

Other: HIV D-/R+

Interventions

HIV D-/R+ OTHER

Receipt of kidney transplant from a deceased donor without HIV.

HIV D-/R+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

University of California, San Diego

San Diego, California, 92037, United States

NOT YET RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

New York University

New York, New York, 10016, United States

NOT YET RECRUITING

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Columbia University

New York, New York, 10032, United States

NOT YET RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

NOT YET RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Durand, MD

CONTACT

410-614-6702; cdurand2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (13)