Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06263426

Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)

This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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-).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV D+/R+

Other

Receipt of kidney transplant from a deceased donor with HIV.

HIV D-/R+

Other

Receipt of kidney transplant from a deceased donor without HIV.

Primary outcomes

  1. Cumulative incidence of death and allograft rejection.

    Time frame: From date of transplant to end of year 1

    Proportion of participants who die or have graft rejection

Secondary outcomes

  1. Participant survival

    Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

    Time to event (death)

  2. Graft survival

    Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

    Time to event (graft loss)

  3. 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)

    Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019)

  4. Time to first rejection

    Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

    Time to event (first rejection)

  5. 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)

    Count of rejection events

  6. 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)

    Estimated glomerular filtration rate, calculated centrally based on local testing results

  7. 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)

    Cumulative incidence of HIV viremia based on local testing

  8. 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)

    Cumulative incidence of new resistance and/or X4 tropic virus based on local testing

  9. 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)

    Cumulative incidence of infections

  10. Incidence of surgical and vascular transplant complications post-transplant

    Time frame: In the first year post-transplant

    Cumulative incidence of complications

  11. 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)

    Cumulative incidence of chronic kidney disease (eGFR<60 for more than 3 months)

  12. Incidence of post-transplant malignancies

    Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)

    Cumulative incidence of malignancies

  13. Incidence of de novo donor specific antibody (DSA)

    Time frame: At month 12 post-transplant

    Based on central testing

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Durand, MD

CONTACT

[email protected]

410-614-6702

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 16, 2024
Registry last updated
Jun 22, 2026

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.

Published trials that share one or more normalized conditions with this study.