Kidney Transplantation in Recipients and Donors with HIV: Long Term Follow up Study
- Study HIC#:2000030204
- Last Updated:07/15/2021
In this research study, we want to find out how well patients who receive a kidney from an HIV-positive (HIV+) donor do over 10 years compared to patients who receive a kidney from an HIV-negative (HIV-) donor. This research study is for adults who are HIV+ and are being evaluated for or are waitlisted to receive a kidney transplant.
- Age18 years and older
- Start Date06/18/2021
- End Date03/31/2031
Participant received a kidney-only transplant under a previous HOPE Act protocol.
If participant has not received a kidney-only transplant under a previous HOPE Act protocol, the following must be met:
1. Participant meets the standard criteria for kidney transplant at the local center.
2. Participant is able to understand and provide informed consent.
3. Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
4. Participant is ≥ 18 years old.
5. CD4+ T-cell count: ≥ 200/μL within 16 weeks of transplant.* There are no study-specified CD4+ T-cell count requirements to accept organs from an HIV- donor.
6. HIV-1 RNA < 50 copies/mL.
7. Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.*
8. Participant meets with an independent advocate per the HOPE Act Safeguards and Research Criteria.*
9. 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 when available.*
If participant has not received a kidney-only transplant under a previous HOPE Act protocol, the following exclusion criteria apply:
1. Participant has a history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary CNS lymphoma.*
2. 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.
*These eligibility criteria align with the eligibility in the Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected with HIV.