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

NCT05159466 | Recruiting

• 1 other identifier: 2021-407
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus; End Stage Renal Disease

Keywords

Organ donor; Organ recipient; Kidney Transplant; HOPE Act; HIV

Outcome Measures

Primary Outcomes (1)

• Patient mortality rate after kidney transplant

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

  1 Year

Secondary Outcomes (2)

• Graft survival in transplant recipients

  3, 6, 9, 12, 24, 36, 48, 60 Months

• Incidence and severity of graft rejection for transplant recipients

  6, 9, 12, 24, 36, 48, 60 Months

Study Arms (2)

Kidney transplant recipients

Up to 25 HIV-positive participants requiring kidney organ transplantation

Procedure: Kidney transplant

Kidney living donors

Up to 5 HIV-positive living donors will be enrolled.

Procedure: Kidney transplant

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.

Also known as: Nephrectomy

Kidney living donors; Kidney transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Donor Criteria Deceased Donor Criteria
• Must meet all clinical criteria for HIV-uninfected organ donors.
• No evidence of invasive opportunistic complications of HIV infection.
• Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study.
• Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA approved laboratory.
• If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
• Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of the study (or at least 5 years).
• For donors with newly diagnosed/discovered HIV-1 infection, any HIV-1 RNA viral load is allowed assuming the donor meets other criteria and the HIV/Transplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Kidney Failure, Chronic

Interventions

Kidney Transplantation; Nephrectomy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Alfred Luk, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfred Luk, MD,

CONTACT

(504) 988-7316; aluk@tulane.edu

Delainna Bartholomew, BS

CONTACT

504-988-6902; dbartho@tulane.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)