Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)

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-).

• Participant survival [Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)]
• Graft survival [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 [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 [Time frame: From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)]
• Serious adverse events post-transplant [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 [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 [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 [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 [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 [Time frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)]