Table 1:
HOPE Safeguards and Research Criteria, as published by the Secretary of the Department of Health and Human Services (HHS) as a Final Rule in November 2015
| Category | Criteria |
|---|---|
| Donor Eligibility | |
| All HIV-positive deceased donors | No evidence of invasive opportunistic complications of HIV infection. |
| Pre-implant donor organ biopsy. | |
| Viral load: no requirement. CD4 count: no requirement. | |
| Deceased donor with known history of HIV infection and prior antiretroviral therapy (ART) | The study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable, and effective. |
| HIV-positive living donor | Well-controlled HIV infection defined as: |
| • CD4+ T-cell count ≥500/µL for the 6-month period before donation | |
| • HIV-1 RNA <50 copies/mL | |
| • No evidence of invasive opportunistic complications of HIV infection | |
| Pre-implant donor organ biopsy | |
| Recipient Eligibility | CD4+ T-cell count ≥200/µL (kidney) |
| CD4+ T-cell count ≥100 µL (liver) within 16 weeks prior to transplant and no history of opportunistic infection (OI); or ≥200 µL if history of OI is present. | |
| HIV-1 RNA <50 copies/mL and on a stable antiretroviral regimen.* | |
| No evidence of active opportunistic complications of HIV infection | |
| No history of primary central nervous system (CNS) lymphoma or progressive multifocal leukoencephalopathy (PML). | |
| Transplant Hospital Criteria | Transplant hospital with established program for care of HIV-positive subjects |
| HIV program expertise on the transplant team. | |
| Experience with HIV-negative to HIV-positive organ transplantation. | |
| Standard operating procedures (SOPs) and training for the organ procurement, implanting/operative, and postoperative care teams for handling HIV-infected subjects, organs, and tissues. | |
| Institutional review board (IRB)-approved research protocol in HIV-positive to HIV-positive transplantation. | |
| Institutional biohazard plan outlining measures to prevent and manage inadvertent exposure to and/or transmission of HIV | |
| Provide each living HIV-positive donor and HIV-positive recipient with an “independent advocate”. | |
| Policies and SOPs governing the necessary knowledge, experience, skills, and training for independent advocates. | |
| OPOPO Responsibilities | SOPs and staff training procedures for working with deceased HIV-positive donors and their families in pertinent history taking; medical chart abstraction; the consent process; and handling blood, tissues, organs, and biospecimens. |
| Biohazard plan to prevent and manage HIV exposure and/or transmission | |
| Prevention of Inadvertent Transmission of HIV | Each participating Transplant Program and OPO shall develop an institutional biohazard plan for handling organs from HIV-positive donors that is designed to prevent and/or manage inadvertent transmission or exposure to HIV. |
| Procedures must be in place to ensure that human cells, tissues, and cellular and tissue-based products (HCT/Ps) are not recovered from HIV-positive donors for implantation, transplantation, infusion, or transfer into a human recipient; however, HCT/Ps from a donor determined to be ineligible may be made available for nonclinical purposes. | |
| Required Outcome Measures | |
| Waitlist Candidates | HIV status |
| CD4+ T-cell counts | |
| Co-infection (hepatitis C virus [HCV], hepatitis B virus [HBV] | |
| HIV viral load | |
| ART resistance | |
| Removal from waitlist (death or other reason) | |
| Time on waitlist | |
| Donors (all) | Type (Living or deceased) |
| HIV status (HIV-infected [HIV-positive] new diagnosis, HIV-positive known diagnosis) | |
| CD4+ T-cell count | |
| Co-infection (HCV, HBV) | |
| HIV viral load | |
| ART resistance | |
| Living Donors | Progression to renal insufficiency in kidney donors |
| Progression to hepatic insufficiency in liver donors | |
| Change in ART regimen as a result of organ dysfunction | |
| Progression to acquired immunodeficiency syndrome (AIDS) | |
| Failure to suppress viral replication (persistent HIV viremia) | |
| Death | |
| Transplant Recipients | Rejection rate (annual up to 5 years) |
| Progression to AIDS | |
| New OI | |
| Failure to suppress viral replication (persistent HIV viremia) | |
| HIV-associated organ failure | |
| Malignancy | |
| Graft failure | |
| Mismatched ART resistance versus donor | |
| Death | |
*
Patients who are unable to tolerate ART due to organ failure or who have recently started ART may have an HIV > 50 copies/mL and still be eligible if the study team anticipates an effective antiretroviral regimen for the patient after transplantation.