Kidney transplantation using organs from HIV-positive donors

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

This study is testing how well kidney transplants from HIV-positive and HIV-negative donors work for people with HIV and if the donor's HIV status affects the success of the transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 13 sites (Birmingham, Alabama and 12 other locations)
• Trial ID: NCT06263426 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented HIV infection who meet local criteria for kidney transplantation.

Not a fit: Patients with significant comorbidities such as progressive multifocal leukoencephalopathy or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could expand organ donation options for HIV-positive patients and improve transplant outcomes.

How similar studies have performed: Other studies have shown promising outcomes for HIV-positive patients receiving organs from HIV-negative donors, but this approach with HIV-positive donors is relatively novel.

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.

Where this trial is running

Birmingham, Alabama and 12 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
• University of California, Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
• University of California, San Diego — San Diego, California, United States (Not_yet_recruiting)
• University of California, San Francisco — San Francisco, California, United States (Not_yet_recruiting)
• Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Not_yet_recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
• New York University — New York, New York, United States (Not_yet_recruiting)
• Icahn School of Medicine at Mt. Sinai — New York, New York, United States (Not_yet_recruiting)
• Columbia University — New York, New York, United States (Not_yet_recruiting)
• Weill Cornell Medical Center — New York, New York, United States (Not_yet_recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD

Conditions Hiv