HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

Inclusion Criteria:

All individuals with advanced heart failure and HIV infection who meet the study inclusion and exclusion criteria will be eligible for participation in the study.

• Participant meets the standard criteria for heart transplant at the local center.

• Participant is able to understand and provide informed consent.

• Participant meets with an independent advocate per the HOPE Act Safeguards andResearch Criteria.

• Documented HIV infection (by any licensed assay, or documented history of detectableHIV-1 RNA).*

• Participant is ≥ 18 years old.

• Opportunistic complications: if prior history of an opportunistic infection, theparticipant has received appropriate therapy and has no evidence of active disease.Medical record documentation should be provided whenever possible.*

• CD4+ (cluster of differentiation 4+) T-cell count: ≥ 200/μL within 16 weeks oftransplant.*

• HIV-1 RNA is below 50 copies RNA/mL./* Viral blips between 50-400 copies will beallowed as long as there are not consecutive measurements > 200 copies/mL. **Organrecipients who are unable to tolerate ART due to organ failure or recently startedAntiretroviral Therapy (ART) may have detectable viral load and still be eligible ifa safe and effective antiretroviral regimen to be used by the recipient aftertransplantation is described.

• Participant is willing to comply with all medications related to their transplantand HIV management.

• For participants with a history of aspergillus colonization or disease, no evidenceof active disease.

• The participant must have or be willing to start seeing a primary medical careprovider with expertise in HIV management.

• Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods thatare more than 80% effective. Female participants of child-bearing potential mustconsult with their physician and determine the most suitable method(s) from thislist to be used from the time that study treatment begins until after studycompletion.

• Participant is not suffering from significant wasting (e.g. body mass index < 21)thought to be related to HIV disease.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

• Participant has a history of progressive multifocal leukoencephalopathy (PML) orprimary central nervous system (CNS) lymphoma.*

• Participant is pregnant or breastfeeding. (Note: Participants who become pregnantpost-transplant will continue to be followed in the study and will be managed perlocal site practice. Women that become pregnant should not breastfeed.)

• Past or current medical problems or findings from medical history, physicalexamination or laboratory testing that are not listed above, which, in the opinionof the investigator, may pose additional risks from participation in the study, mayinterfere with the participant's ability to comply with study requirements or thatmay impact the quality or interpretation of the data obtained from the study.