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Kidney Transplant for HIV-Positive Individuals Using HIV-Positive Donor Organs

This study at the Tulane Abdominal Transplant Institute is looking at kidney transplants for adults living with HIV who also have end-stage kidney disease. The study will use kidneys from HIV-positive donors for HIV-positive recipients. The main goal is to see how many patients are still alive one year after their kidney transplant. You may be able to join if you are 18 or older, have HIV, meet standard transplant criteria, and have a CD4+ T-cell count of 200/μL or higher. This is an observational study, meaning researchers will watch and collect information about your transplant and recovery as part of your regular care.

Study design
This is an observational study involving 30 participants (25 recipients and 5 living donors). It is designed to watch and collect information about solid organ transplantation.
What's involved
Participants will be evaluated and followed for organ transplantation as part of standard care. The study will observe your health after a kidney transplant.
Compensation
Not stated in the trial record.
Follow-up
Patient mortality rate will be measured at 1 year after the kidney transplant.

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NCT05159466

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

Recruiting
Not specifiedAges 18+Observational
Tulane University
~30 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Kidney transplant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient mortality rate after kidney transplant
Measured over 1 Year

Conditions

Human Immunodeficiency Virus
End Stage Renal Disease

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Chronic Kidney Disease, Stage 5HIV InfectionHIV Infection

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Alfred Luk, MD · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Alfred Luk, MD,
[email protected]
(504) 988-7316
Email the study team

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Eligibility criteria

Inclusion

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. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
No history of primary CNS lymphoma or progressive PML

Exclusion

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

What this trial measures

  • Patient mortality rate after kidney transplant1 Year

    Patient will be followed after kidney transplant and the mortality rate will be measured by patient survival post op.