HIV D+/R+
OtherReceipt of kidney transplant from a deceased donor with HIV.
NCT Number: NCT06263426
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.
Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of their HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of their HIV. This study will look to better understand rejection in transplant recipients with HIV (HIVR+) who receive kidneys from donors with HIV (HIVD+) vs without HIV (HIVD-).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receipt of kidney transplant from a deceased donor with HIV.
Receipt of kidney transplant from a deceased donor without HIV.
Time frame: From date of transplant to end of year 1
Proportion of participants who die or have graft rejection
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Time to event (death)
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Time to event (graft loss)
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019)
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Time to event (first rejection)
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Count of rejection events
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Estimated glomerular filtration rate, calculated centrally based on local testing results
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Cumulative incidence of HIV viremia based on local testing
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Cumulative incidence of infections
Time frame: In the first year post-transplant
Cumulative incidence of complications
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Cumulative incidence of chronic kidney disease (eGFR<60 for more than 3 months)
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Cumulative incidence of malignancies
Time frame: At month 12 post-transplant
Based on central testing
Contact information is provided by the study sponsor or research team.
Johns Hopkins University
Other
HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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