Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients (NCT03408106) | Clinical Trial Compass
CompletedNot Applicable
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
United States3 participantsStarted 2017-08-01
Plain-language summary
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Who can participate
Age range
21 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:
* Able to understand and provide consent
* Age 21 years or older
* Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy
* Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA)
* CD4+ T-cell count ≥ 500/µL for 6 months prior to donation
* HIV-1 RNA below 50 copies RNA/mL (viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \>200 copies/mL)
Exclusion Criteria:
* Two high risk alleles of APOL1 (G1 or G2 variants)
* Hypertension
* Diabetes
* Chronic active hepatitis C (detectable HCV RNA in plasma)
* Evidence of invasive opportunistic complications from HIV infection
* Mentally incompetent and/or inability to provide informed consent
* Other medical conditions, as determined by the provider, that would preclude donation
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.
1Since this trial is now completed and was tracking adverse events in HIV-positive people who received a kidney from an HIV-positive donor, has the safety data been published yet, and what does it show about the risks specific to this kind of transplant?
2Because both the donor and recipient in this trial were HIV-positive, how might receiving a kidney from an HIV-positive donor affect my own HIV management after the transplant, and could it complicate my antiretroviral therapy?
3Since the trial's primary focus was on adverse events rather than long-term survival or kidney function outcomes, what do we actually know so far about how well these transplants work over time, and is that enough information for me to make an informed decision?
4Would my doctor consider this type of HIV-positive to HIV-positive kidney donation a realistic option for me given my current HIV status, viral load, and overall health, or would a kidney from an HIV-negative donor still be the more standard path?
5Are there other completed or ongoing studies I should know about that compare outcomes between HIV-positive donor kidneys and HIV-negative donor kidneys, so we can weigh the risks and benefits more fully before deciding on a direction??
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.