Kidney transplantation using organs from HIV-positive donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to investigate the rejection rates and long-term outcomes in kidney transplant recipients with HIV who receive organs from both HIV-positive and HIV-negative donors. Following the implementation of the HIV Organ Policy Equity (HOPE) Act, this study seeks to expand the understanding of transplant viability for HIV-positive patients. Participants will be monitored for their ability to maintain HIV control post-transplant and the impact of donor HIV status on transplant rejection. The study includes a comparison of outcomes between two groups: those receiving kidneys from HIV-positive donors and those from HIV-negative donors.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of California, Davis
  Sacramento, California, United States Recruiting
• University of California, San Diego
  San Diego, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD
• Email: cdurand2@jhmi.edu
• Phone: 410-614-6702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.