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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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