Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors

Recipient Criteria

Inclusion Criteria:

• Participant meets standard listing criteria for transplant.

• Greater than or equal to 18 years of age.

• Participant has documented HIV infection using an FDA-licensed, approved, or clearedtest device(s).

• CD4+ T-cell count ≥200/μL within 16 weeks prior to transplant; any patient withhistory of Opportunistic Infections must have a CD4 positive T-cell count ≥200/uL.

• HIV RNA less than 50 copies/mL and on a stable antiretroviral regimen.

• No evidence of active opportunistic complications of HIV infection.

• On a stable antiretroviral regimen. Participants unable to tolerate ART due to organfailure may still be considered eligible if the study team is confident there willbe a safe, tolerable, and effective antiretroviral regimen once organ function isrestored after transplantation.

• No history of primary CNS lymphoma or progressive PML

Exclusion Criteria:

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

• Less than 18 years of age.

• Requires multi-organ transplantation.

• Participant is pregnant or breastfeeding.

• Participant has a history of progressive multifocal leukoencephalopathy (PML),chronic intestinal cryptosporidiosis of > 1 month duration, or primary CNS lymphoma.

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

• Participants who are unable or unwilling to provide informed consent.

Donor Criteria Deceased Donor Criteria

1. Must meet all clinical criteria for HIV-uninfected organ donors.

2. No evidence of invasive opportunistic complications of HIV infection.

3. Pre-implant donor organ biopsy showing no disease process that would put therecipient at increased risk of rapid progression to end-stage organ failure, to bestored for the duration of the study.

4. Donor has documented HIV infection (by any licensed ELISA and confirmation byWestern Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIAapproved laboratory.

5. If known history of HIV infection and prior antiretroviral therapy, the study teammust describe the anticipated post-transplant antiretroviral regimen(s) to beprescribed for the recipient and justify its conclusion that the regimen will besafe, tolerable and effective.

6. Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of thestudy (or at least 5 years).

7. For donors with newly diagnosed/discovered HIV-1 infection, any HIV-1 RNA viral loadis allowed assuming the donor meets other criteria and the HIV/Transplant InfectiousDiseases team is able to predict a tolerable and effective ART regimen for therecipient.

8. If there is any history of documented antiretroviral resistance in the donor bymedical chart review, the HIV/Transplant Infectious Diseases team is able to predicta tolerable and effective ART regimen for the recipient.

9. Donors with documented chronic hepatitis C virus (HCV+) co-infection (detectable HCVnucleic acid using any licensed assay in a CLIA certified lab) can be used only forHCV+ participants.

Living Donor Criteria

1. Greater than or equal to 18 years of age

2. Donor meets all clinical criteria to be a living donor other than being HIVpositive.

3. Donor has consented to participate as a HIV-Positive Donor under the separateAddendum protocol.

4. Documented HIV infection using an FDA-licensed, approved, or cleared test device.

5. Well-controlled HIV infection, as evidenced by:

6. CD4+ T-cell count ≥500/mL for the 6-month period preceding donation.

7. Fewer than 50 copies/mL of HIV- 1 RNA detectable by ultrasensitive or real-timepolymerase chain reaction (PCR) assay.

8. No evidence of invasive opportunistic complications of HIV infection

9. A kidney biopsy showing no evidence of a disease process that would put the donor atincreased risk of progressing to end-stage organ failure after donation, or thatwould present a risk of poor graft function to the recipient.

10. A complete history of ART regimens and ART resistance.

11. The study team must be able to predict a safe, tolerable, and effective regimen tobe prescribed for the recipient based on the donor's current ART regimen as well asthe donor's history of ART resistance.