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

Johns Hopkins University200 enrolled

Overview

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

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-).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Hiv

Interventions

HIV D+/R+OTHER

Receipt of kidney transplant from a deceased donor with HIV.

HIV D-/R+OTHER

Receipt of kidney transplant from a deceased donor without HIV.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

University of Alabama at Birmingham

Birmingham, Alabama, United States

NOT_YET_RECRUITING

University of California, Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Cumulative incidence of death and allograft rejection.

Proportion of participants who die or have graft rejection

Time frame: From date of transplant to end of year 1