Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors (TATI HOPE Act)
Tulane University
Summary
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
Description
This is an observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV-positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. 25 stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation and 5 living donors (kidney) will be of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cleared test device(s). * CD4+ T-cell count ≥200/μL within 16 weeks prior to transplant; any patient with history 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. Part…
Interventions
- ProcedureKidney transplant
Participants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
Location
- East Jefferson General HospitalMetairie, Louisiana