Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients

This is an observational study designed to evaluate safety and outcomes of solid organ
transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate
overall survival and graft survival compared to transplantation with an HIV- organ.

In addition the study will assess potential complications of organ transplant using HIV+
deceased donors - including but not limited to - HIV superinfection, incidence and severity
of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial
infections, and opportunistic infections.

Inclusion Criteria:

All individuals with end-stage organ disease and HIV infection who meet standard clinical
criteria for transplantation and the study inclusion and exclusion criteria will be
eligible for participation in the study.

1. Participant is able to understand and provide informed consent

2. Participant meets standard listing criteria for transplant.

3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot,
positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable
HIV-1 RNA).

4. Participant is > 18 years old.

5. Opportunistic Complications: None or previous history of protocol allowed
opportunistic infections or neoplasms with appropriate acute and maintenance therapy
and no evidence of active disease.

6. Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.

7. Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed
in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a
stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies
RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final
Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA
monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL)
should be < 50 copies, but this result can be documented outside the 16 week window
according to the judgement of the local clinical team and site investigator. Organ
recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ
failure or who have only recently started ART may have detectable viral load and still
be considered eligible if the study team is confident there will be a safe, tolerable,
and effective antiretroviral regimen to be used by the recipient once organ function
is restored after transplantation.

8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and
fungal prophylaxis as indicated.

Exclusion Criteria:

1. Participant has concomitant conditions that, in the judgment of the investigators,
would preclude transplantation or immunosuppression.

2. Opportunistic Complication History: Any history of progressive multifocal
leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration,
or primary Central Nervous System (CNS) lymphoma.

3. Participant has a history of any neoplasm except for the following: resolved Kaposi's
sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell
carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with
curative therapy and disease free for more than 5 years. History of renal cell
carcinoma requires disease free state for 2 years. History of leukemia and
disease-free duration will be per site policy.

4. 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
clinical practice. Women that become pregnant should not breastfeed.