Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients

NCT03170414 | Completed DMC

• 1 other identifier: SURG-2017-24985
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients. HIV-positive individuals who agree to accept and receive a solid organ transplant from and HIV-positive donor will be followed to determine the safety and efficacy of this practice.

Conditions

HIV; Awaiting Organ Transplant

Keywords

HIV; Kidney Transplant; Liver Transplant; Transplant; HOPE Act

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  Patient survival at one year.

  One Year

Secondary Outcomes (11)

• Graft Survival

  Months 3, 6, 9, Years 1, 2, 3

• Incidence and Severity of Graft Rejection

  Through study completion, up to three years

• HIV Disease Progression

  Through study completion, up to three years

• Development of antiretroviral resistance mutations and/or X4 tropic virus in blood and allograft

  Through study completion, up to three years

• Incidence of bacterial, fungal, viral and other opportunistic infections

  Through study completion, up to three years

Study Arms (1)

HIV D+/R+

HIV+ recipients who receive an organ transplant from an HIV+ donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable HIV-infected adults in need of a solid organ transplant (kidney, liver) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney, liver) and living donors (liver) will be utilized in this protocol. No living kidney donors will be enrolled.

You may qualify if:

• Participant is able to understand and provide informed consent.
• Participant meets standard listing criteria for transplant.
• Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA).
• Participant is ≥ 18 years old.
• No evidence of active opportunistic complications of HIV infection.
• Participant CD4+ T-cell count is \>/= 200/µL within 16 weeks prior to transplant for kidney transplant recipients. For liver transplant recipient, CD4+ T-cell counts need to be \>/= 100/ul (or \>/= 200/µL if history of opportunistic infection) within 16 weeks prior to transplant.
• Participant most recent HIV-1 RNA \< 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Participants unable to tolerate ART due to organ failure or who have only recently started ART may have detectable viral load and 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.
• Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant.
• No history of primary CNS lymphoma or progressive PML.
• 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.

You may not qualify if:

• \. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
• DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney)
• 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 to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
• HIV-Positive Living Donor (liver)
• Donor meets all clinical criteria to be a living liver donor other than being HIV positive.
• 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.
• No evidence of invasive opportunistic complications of HIV infection
• Donor CD4+ T-cell count is \>/= 500/µL in the 26 weeks prior to donation.
• The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation.
• On a stable antiretroviral regimen.
• Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

Location

Study Officials

• Timothy Pruett, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: June 15, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)