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

Part of paid clinical trials in Metairie, Louisiana.

Sponsor
Tulane University
Study ID
NCT05159466
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kidney transplant — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Nov 15, 2021
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Kidney transplant recipients
    Up to 25 HIV-positive participants requiring kidney organ transplantation
  • Arm: Kidney living donors
    Up to 5 HIV-positive living donors will be enrolled.

Primary Outcome Measure

Patient mortality rate after kidney transplant [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
East Jefferson General HospitalMetairieLouisiana70006
Alfred Luk, MD
[email protected]
504-988-7316
Delainna Bartholomew, BS
[email protected]
504-988-6902
Alfred Luk, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Metairie, LA

By condition
HIV
By specialty
Infectious disease
By research site
East Jefferson General Hospital· Metairie, LA

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