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Can kidneys from HIV-Positive donors save more lives?

NCT ID NCT03500315

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial tests whether kidneys from deceased HIV-positive donors can be safely transplanted into people living with HIV. Researchers track major complications like graft failure, serious side effects, and HIV progression. The goal is to see if using these organs is a safe way to expand the donor pool and shorten transplant wait times.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kidney transplant from an HIV-infected deceased donor
What this could lead to
If successful, this could expand the donor pool for people with HIV, reducing wait times and improving access to life-saving kidney transplants.
What could go wrong
The trial is still gathering evidence, and risks include transplant rejection, serious side effects, HIV breakthrough, or infections. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

207 people

The number who actually took part.

Started

Apr 2018

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant meets the standard criteria for kidney transplant at the local center. * Participant is able to understand and provide informed consent. * Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards. * Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA). * Participant is ≥18 years old. * Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. * Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant. * HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements \>200 copies/mL. * Participant is willing to comply with all medication related to their transplant and HIV management. * For participant with a history of aspergillus colonization or disease, no evidence of active disease. * The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management. * All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control. * Participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to HIV disease. Exclusion Criteria: * Participant has a history of progressive multifocal leukoencephalopathy (PML) 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 or may impact the quality or interpretation of the data obtained from the study.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Drexel University

    Philadelphia, Pennsylvania, 19102, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Georgetown Transplant Institute

    Washington D.C., District of Columbia, 20007, United States

  • Methodist Health System Clinical Research Institute

    Dallas, Texas, 75203, United States

  • Miami Transplant Institute

    Miami, Florida, 33136, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • UPMC-University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    San Diego, California, 92103, United States

  • University of California, San Francisco

    San Francisco, California, 94193, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Maryland, Institute of Human Virology

    Baltimore, Maryland, 212101, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8022, United States

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