Actively Recruiting
Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors
Led by Tulane University · Updated on 2025-10-02
30
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet standard criteria for transplant listing
- Age 18 years or older
- Documented HIV infection confirmed by an FDA-approved test
- CD4+ T-cell count of 200 or higher within 16 weeks before transplant
- HIV RNA less than 50 copies/mL and on a stable antiretroviral regimen
- No active opportunistic HIV infections
- Stable antiretroviral therapy; exceptions allowed if organ failure precludes tolerance but expected to improve post-transplant
- No history of primary CNS lymphoma or progressive multifocal leukoencephalopathy (PML)
You will not qualify if you...
- Conditions judged by investigators to prevent safe transplantation or immunosuppression
- Under 18 years of age
- Requires multiple organ transplants
- Pregnant or breastfeeding
- History of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis lasting more than 1 month, or primary CNS lymphoma
- History of cancer except resolved Kaposi's sarcoma, treated in situ anogenital carcinoma, treated basal or squamous cell skin cancer, or solid tumors disease-free for over 5 years
- History of renal cell carcinoma unless disease-free for 2 years
- History of leukemia per site policy
- Unable or unwilling to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
Actively Recruiting
Research Team
A
Alfred Luk, MD,
CONTACT
D
Delainna Bartholomew, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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