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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2029-09-30

Brief Summary

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

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Detailed Description

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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-).

Conditions

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Hiv

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV D+/R+

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

Group Type EXPERIMENTAL

HIV D+/R+

Intervention Type OTHER

Receipt of kidney transplant from a deceased donor with HIV.

HIV D-/R+

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

Group Type EXPERIMENTAL

HIV D-/R+

Intervention Type OTHER

Receipt of kidney transplant from a deceased donor without HIV.

Interventions

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HIV D+/R+

Receipt of kidney transplant from a deceased donor with HIV.

Intervention Type OTHER

HIV D-/R+

Receipt of kidney transplant from a deceased donor without HIV.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Durand, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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