Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive … (NCT03170414) | Clinical Trial Compass
CompletedNot Applicable
Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients
United States10 participantsStarted 2017-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion 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 to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
✕. 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