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

Johns Hopkins University

Status: Enrolling

Conditions: Hiv

Treatments: Other: HIV D+/R+; Other: HIV D-/R+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06263426

U01AI177211 (U.S. NIH Grant/Contract)

IRB00387066

Details and patient eligibility

About

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

Full 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-).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

HIV D+/R+

Experimental group

Description:

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

Treatment:

Other: HIV D+/R+

HIV D-/R+

Experimental group

Description:

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

Treatment:

Other: HIV D-/R+