HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

The primary objective is to evaluate the safety of heart transplantation in HIV‐positiverecipients and to study any potential complications of solid organ transplantation in therecipient, as well as assess the long‐term health and mortality.Secondary objectives are to compare other clinical outcomes between HIV+ transplantrecipients of hearts from HIV+ and HIV‐ donors.HIV D+/R+ transplantation is still less common than HIV D‐/R+ transplantation due to theoverall availability of donor organs. Additionally, most of the HIV D+/R+ transplantshave been done for kidney transplants. Overall, there is more data accruing regardingtransplantation and HIV disease, but most of the procedures are done in the kidney andliver organ systems. Not only is it important to further expand the donor pool forpatients with HIV and heart failure, further data is needed in thoracic organtransplantation and HIV‐positive recipients. The HIV Organ Policy Equity Act (HOPE Act ‐enacted on November 21, 2013), made it possible for an HIV+ recipient to receive an HIV+organ as a part of a research study.HIV+ Deceased Donor Criteria: 1. Donation after brain death or cardiac death. 2. HIV+ donors have confirmed or suspected HIV infection* (by medical record historyand/or a licensed HIV test.) If HIV infection is diagnosed during the donorevaluation process, a second confirmatory test will be required). 3. Donor has no active opportunistic infections, neoplasms, or severe acute retroviralsyndrome; if previous history of an opportunistic infection, donor has receivedappropriate treatment. 4. Donors may have any HIV‐1 RNA viral load provided a safe, tolerable and effectivepost‐transplant antiretroviral regimen to be prescribed for the recipient isanticipated, described and justified. 5. Donors with active hepatitis C virus (HCV) infection (detectable HCV nucleic acid bylicensed assay in a Clinical Laboratory Improvement Amendments (CLIA) certified labare acceptable based on local site practice.