HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver
donor is safe with regards to survival and major transplant-related and HIV-related
complications compared to receiving a liver from an HIV-uninfected deceased liver donor
(HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be
followed in the full study or followed in the nested observational group

Inclusion Criteria:

- Participant meets the standard criteria for liver transplant at the local center.

- Participants being listed for a simultaneous liver kidney (SLK) are eligible if
participants meet the standard criteria for both organs.

- Participant is able to understand and provide informed consent.

- Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE)
Act Safeguards and Research Criteria.

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

- Participant is ≥ 18 years old.

- Opportunistic complications: prior history of certain opportunistic infections is not
an exclusion if the participant has received appropriate therapy and has no evidence
of active disease. Medical record documentation should be provided whenever possible.

- CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of
AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.

- HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as
long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who
are unable to tolerate anti-retroviral therapy (ART) due to organ.

failure or recently started ART may be eligible despite a detectable viral load if safe and
effective ART to be used by the recipient after transplantation is described.

- Participant must have or be willing to start seeing a primary medical care provider
with expertise in HIV management.

- Participant is willing to comply with all medications related to participant's
transplant and HIV management.

- For participants with a history of aspergillus colonization or disease, no current
clinical evidence of active disease.

- Agreement to use contraception.

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

Exclusion Criteria:

- Participant has a history of progressive multifocal leukoencephalopathy (PML), or
primary central nervous system (CNS) lymphoma.*

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

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