This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors 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 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 HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Mayo Clinic, Arizona
Phoenix, Arizona, United States
Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
Cumulative incidence of composite event of opportunistic infection or cancer
Time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Participant survival
Time to event (death)
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft survival
Time to event (graft loss)
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant
Cumulative incidence of infections
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence and type of post-transplant cancer as determined by local pathology
Cumulative incidence of cancer determined by local pathology
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Serious adverse events post-transplant
Cumulative incidence of serious adverse events
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of rejection events post-transplant
Cumulative incidence of rejection events
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Cedars-Sinai Medical Center
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of Colorado Anschutz
Aurora, Colorado, United States
NOT_YET_RECRUITINGMayo Clinic, Florida
Jacksonville, Florida, United States
NOT_YET_RECRUITINGUniversity of Miami, Miami Transplant Institute
Miami, Florida, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGNorthwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGOchsner Clinic Foundation
Jefferson, Louisiana, United States
NOT_YET_RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITING...and 9 more locations
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index
Mean value of graft function
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant
Cumulative incidence of HIV-breakthrough and HIV persistent viral failure
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant
Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
Incidence of surgical and vascular transplant complications during the first year post-transplant
Cumulative incidence of complications
Time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)