HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

The primary objective is to evaluate the safety of heart transplantation in HIV-positive recipients and to study any potential complications of solid organ transplantation in the recipient, as well as assess the long-term health and mortality. Secondary objectives are to compare other clinical outcomes between HIV+ transplant recipients of hearts from HIV+ and HIV- donors. HIV D+/R+ transplantation is still less common than HIV D-/R+ transplantation due to the overall availability of donor organs. Additionally, most of the HIV D+/R+ transplants have been done for kidney transplants. Overall, there is more data accruing regarding transplantation and HIV disease, but most of the procedures are done in the kidney and liver organ systems. Not only is it important to further expand the donor pool for patients with HIV and heart failure, further data is needed in thoracic organ transplantation 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 history and/or a licensed HIV test.) If HIV infection is diagnosed during the donor evaluation process, a second confirmatory test will be required). 3. Donor has no active opportunistic infections, neoplasms, or severe acute retroviral syndrome; if previous history of an opportunistic infection, donor has received appropriate treatment. 4. Donors may have any HIV-1 RNA viral load provided a safe, tolerable and effective post-transplant antiretroviral regimen to be prescribed for the recipient is anticipated, described and justified. 5. Donors with active hepatitis C virus (HCV) infection (detectable HCV nucleic acid by licensed assay in a Clinical Laboratory Improvement Amendments (CLIA) certified lab are acceptable based on local site practice.