HivNCT06263426
Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
A study testing HIV D+/R+ and HIV D-/R+ in people with Hiv, run by Johns Hopkins University at 18 sites in United States.
Trial summary
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- HIV D+/R+ and HIV D-/R+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- 22 May 2024to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Christine Durand, MD, cdurand2@jhmi.edu
Christine Durand, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Shikha Mehta, MD, smehta@uabmc.edu
Shikha Mehta, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nahel Elias, MD, elias.nahel@mgh.harvard.edu
Nahel Elias, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Valentina Stosor, MD, v-stosor@northwestern.edu
Valentina Stosor, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Carlos Santos, MD, Carlos_A_Santos@rush.edu
Carlos Santos, MD
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Kevin Grimes, MD, MPH, kagrimes@houstonmethodist.org
Kevin Grimes, MD, MPH
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Shennen A Mao, MD, Mao.Shennen@mayo.edu
Shennen A Mao, MD
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Jonathan Hand, MD, jonathan.hand@ochsner.org
Jonathan Hand, MD
- Recruiting
New York University
New York, New York, 10016
Sapna Mehta, MD, Sapna.mehta@nyumc.org
Sapna Mehta, MD
- Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Sander Florman, MD, Sander.florman@mountsinai.org
Sander Florman, MD
- Recruiting
Columbia University
New York, New York, 10032
Marcus Pereira, MD
Marcus Pereira, MD
- Not yet recruiting
Weill Cornell Medical Center
New York, New York, 10065
Catherine Small, MD, Cbs9003@med.cornell.edu
Catherine Small, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Emily Blumberg, MD, eblumber@pennmedicine.upenn.edu
Emily Blumberg, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Ghady Haidar, MD, haidarg@upmc.edu
Ghady Haidar, MD
- Recruiting
University of California, Davis
Sacramento, California, 95817
Sana J Shaikh, MD, sjshaikh@health.ucdavis.edu
Sana J Shaikh, MD
- Recruiting
University of California, San Diego
San Diego, California, 92037
Saima Aslam, MBBS, saslam@ucsd.edu
Saima Aslam, MBBS
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Garrett Roll, MD, Garrett.Roll@ucsf.edu
Garrett Roll, MD
- Recruiting
Washington University St. Louis Barnes Jewish Hospital
St Louis, Missouri, 63110
Ige George, MD, MS, igegeorge@wustl.edu
Ige George, MD, MS
About this study
Official title: HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Read the detailed description
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-).
- Conditions
- Hiv
- Being tested
- HIV D+/R+, HIV D-/R+
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV D+/R+ | Experimental | People living with HIV who receive kidneys from deceased donors with HIV Receives: Other: HIV D+/R+ |
| HIV D-/R+ | Experimental | People living with HIV who receive kidneys from deceased donors without HIV Receives: Other: HIV D-/R+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of death and allograft rejection.
Proportion of participants who die or have graft rejection
Measured: From date of transplant to end of year 1
Secondary outcomes (13)
Participant survival
Time to event (death)
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Graft survival
Time to event (graft loss)
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Type and severity of graft rejection
Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019)
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Time to first rejection
Time to event (first rejection)
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Rate of rejection events over time
Count of rejection events
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Graft function over time measured by eGFR trajectory
Estimated glomerular filtration rate, calculated centrally based on local testing results
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of HIV viremia post-transplant
Cumulative incidence of HIV viremia based on local testing
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant
Cumulative incidence of new resistance and/or X4 tropic virus based on local testing
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant
Cumulative incidence of infections
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of surgical and vascular transplant complications post-transplant
Cumulative incidence of complications
Measured: In the first year post-transplant
Incidence and causes of chronic kidney disease post-transplant
Cumulative incidence of chronic kidney disease (eGFR<60 for more than 3 months)
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of post-transplant malignancies
Cumulative incidence of malignancies
Measured: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of de novo donor specific antibody (DSA)
Based on central testing
Measured: At month 12 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start22 May 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Durand, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263426
- Sponsor's protocol ID
- IRB00387066
- Other IDs
- U01AI177211
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE in Action Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT06263426
- Acronym / sponsor ID
- IRB00387066
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 May 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Detailed description
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-).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV D+/R+ | Experimental | Other: HIV D+/R+People living with HIV who receive kidneys from deceased donors with HIV |
| HIV D-/R+ | Experimental | Other: HIV D-/R+People living with HIV who receive kidneys from deceased donors without HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV D+/R+Receipt of kidney transplant from a deceased donor with HIV. | Other | HIV D+/R+ |
| HIV D-/R+Receipt of kidney transplant from a deceased donor without HIV. | Other | HIV D-/R+ |
Primary outcome
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
13 secondary outcomes
Participant survival
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Graft survival
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
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)
Time to first rejection
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
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)
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)
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)
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)
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)
Incidence of surgical and vascular transplant complications post-transplant
Time frame: In the first year post-transplant
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)
Incidence of post-transplant malignancies
Time frame: From transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Incidence of de novo donor specific antibody (DSA)
Time frame: At month 12 post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Durand, MD principal investigator
Johns Hopkins University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV D+/R+ and HIV D-/R+ in people with Hiv, run by Johns Hopkins University at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Durand, MD (410-614-6702, cdurand2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of death and allograft rejection. (time frame: From date of transplant to end of year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.