This study is not yet accepting patients

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

a study on HIV/AIDS Kidney Transplant

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Joanna Schaenman, MD, PhD (ucla)Saima Aslam, MBBS (ucsd)Garrett Roll, MD (ucsf)

Description

Summary

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

Official Title

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

Details

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-).

Keywords

Hiv, HIV D+/R+, HIV D-/R+

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • Cluster of differentiation 4 (CD4+) T-cell count: ≥ 200/μL within 16 weeks of transplant.
  • 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.
  • Participant meets with an independent advocate.

You CAN'T join if...

  • 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.

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • University of California, San Diego
    San Diego California 92037 United States
  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientists at University of California Health

  • Joanna Schaenman, MD, PhD (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 76 research publications
  • Saima Aslam, MBBS (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 99 research publications
  • Garrett Roll, MD (ucsf)
    Associate Professor, Surgery, School of Medicine. Authored (or co-authored) 110 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT06263426
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated