Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIV D+/R+, HIV D-/R+.
- Who it may be relevant to
- Registry conditions: Hiv. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
Overview
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Detailed description
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-).
Interventions
- Other HIV D+/R+
Receipt of kidney transplant from a deceased donor with HIV. - Other HIV D-/R+
Receipt of kidney transplant from a deceased donor without HIV.
Primary outcome measures
- Cumulative incidence of death and allograft rejection. [Time frame: From date of transplant to end of year 1]
Secondary outcome measures (12)
- Participant survival [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Graft survival [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Type and severity of graft rejection [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Time to first rejection [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Rate of rejection events over time [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Graft function over time measured by eGFR trajectory [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of HIV viremia post-transplant [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of surgical and vascular transplant complications post-transplant [Time frame: In the first year post-transplant]
- Incidence and causes of chronic kidney disease post-transplant [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
- Incidence of post-transplant malignancies [Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)]
Eligibility criteria
Inclusion criteria
- Participant meets local criteria for kidney transplant.
- Participant is able to understand and provide informed consent.
- Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
- Participant is ≥ 18 years old.
- HIV-1 RNA < 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL.
- Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.
Exclusion criteria
- Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or primary central nervous system (CNS) lymphoma.
- Participant is pregnant or breastfeeding.
- Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- University of Alabama at Birmingham — Birmingham
- University of California, Davis — Sacramento
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
- Mayo Clinic Florida — Jacksonville
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
- Ochsner Clinic Foundation — New Orleans
- … and 10 more centers
Identifiers
NCT: NCT06263426 · IRB00387066 · U01AI177211