HivNCT03500315
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
A study testing HIV D+/R+ in people with Hiv, run by Johns Hopkins University at 29 sites in United States.
Trial summary
The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. 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+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 29 sitesUnited States
- Study dates
- 19 Apr 2018to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21205
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 212101
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Methodist Health System Clinical Research Institute
Dallas, Texas, 75203
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Indiana University
Indianapolis, Indiana, 46202
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of California, Los Angeles
Los Angeles, California, 90095
Miami Transplant Institute
Miami, Florida, 33136
Yale University School of Medicine
New Haven, Connecticut, 06520-8022
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York University School of Medicine
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Drexel University
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC-University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California, San Diego
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94193
MedStar Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.
Read the detailed description
This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.
- Conditions
- Hiv
- Being tested
- 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
Kidney from an HIV-infected deceased donor
| Study group | Role | What they receive |
|---|---|---|
| HIV D+/R+ | Experimental | HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100 Receives: Other: HIV D+/R+ |
| HIV D-/R+ | No intervention | HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100 |
| HIV D-/R+ (observational) | No intervention | HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
Measured: From date of transplant through administrative censorship at study completion, up to 4 years
Secondary outcomes (30)
Pre-transplant Mortality
Cumulative incidence of mortality while enrolled before transplant
Measured: At 1 and 2 years post-consent, prior to transplant
Graft Failure
Cumulative incidence of graft failure
Measured: At 1 and 3 years post transplant
Rate of Serious Adverse Events
Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Measured: From date of transplant through graft failure or administrative censorship at study completion, up to year 4
6-month Acute Rejection
Percentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Measured: At 6 months post-transplant
1-year Acute Rejection
Percentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Measured: From date of transplant to end of year 1
Incidence of Graft Rejection
Cumulative incidence of acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Measured: At 1 and 3 years post transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Measured: At 3 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73 m^2
Measured: At 6 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73 m^2
Measured: 9 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73 m^2
Measured: At year 1 post-transplant
Graft Function Number of Participants With eGRF<60 mL/Min/1.73 m^2
Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73 m^2
Measured: At year 2 post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73 m^2
Measured: At year 3 post-transplant
Graft Function -Mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 3 months post-transplant
Graft Function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 6 months post-transplant
Graft Function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 9 months post-transplant
Graft Function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 1 year post-transplant
Graft Function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 2 years post-transplant
Graft Function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Measured: 3 years post-transplant
Graft Function - Slope eGFR
The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis)
Measured: From date of transplant to end of follow-up, up to 4 years
Donor and Recipient Apolipoprotein L1 (APOL1)
Percentage of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient
Measured: Baseline
Participants With Undetectable HIV RNA
Trajectory of recipient plasma HIV RNA over time. Analysis of repeated measures of plasma HIV RNA (longitudinal model). Below 50 copies/mL was used as the threshold of undetectable HIV RNA.
Measured: From date of transplant through end of follow-up, up to 4 years
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model)
Measured: From date of transplant through end of follow up, up to 4 years
Incidence of Antiretroviral Resistance
Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
Measured: From date of transplant through end of follow-up, up to 4 years
Incidence of X4 Tropic Virus
Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
Measured: From date of transplant through end of follow-up, up to 4 years
Incidence of Opportunistic Infection
Cumulative incidence of opportunistic infections
Measured: From date of transplant through end of follow-up, up to 4 years
Incidence of Surgical Complications
Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Measured: From date of transplant through year 1
Incidence of Vascular Complications
Number of vascular complications within 1 year of transplant
Measured: From date of transplant through year 1
Incidence of Viral-related Malignancies
Number of malignancies as determined by local pathology
Measured: From date of transplant through end of follow-up, up to 4 years
Participants With Formation of de Novo Donor-specific Human Leukocyte Antigen(HLA) Antibodies
Participants must have donor-specific HLA data at both day 0 and at 1 year to be included in the analysis. A total of 32 HIV D+/R+ and 40 HIV D-/R+ participants were excluded due to missing donor-specific data at either day 0 or 1 year.
Measured: From date of transplant through end of year 1
Composite Event, Cumulative Incidence
Cumulative incidence of the composite event, which is defined as the occurrence of first event of any of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness
Measured: At 6 months, 1 and 3 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start19 Apr 2018
- Primary completion30 Sep 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 207 participants (actual)
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
- NCT03500315
- Sponsor's protocol ID
- IRB00141138
- Other IDs
- U01AI134591
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2018
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sulaiman A, Tamil Selvan M, Yang P, Zhu X, Eby Y, Benner SE, Fernandez RE, Hussain S, Brown D, Desai N, Florman S, Rana MM, Friedman-Moraco R, Pereira MR, Mehta S, Stock P, Gilbert A, Morris MI, Stosor V, Mehta SA, Small CB, Ranganna K, Santos CAQ, Aslam S, Malinis M, Elias N, Blumberg EA, Massie A, Smith ML, Morsheimer M, Laird GM, Siliciano R, Segev DL, Durand CM, Redd AD, Tobian AA. Allograft Rejection and the Latent HIV Reservoir in Kidney Transplant Recipients with HIV. J Infect Dis. 2026 Mar 13:jiag154. doi: 10.1093/infdis/jiag154. Online ahead of print.
PubMed 41823991Zhu X, Morgenlander WR, Brown DM, Eby Y, Morsheimer M, Odim J, Bagnasco SM, Rana MM, Florman SS, Friedman-Moraco RJ, Stock PG, Gilbert AJ, Mehta S, Stosor V, Mehta SA, Pereira MR, Small CB, Morris MI, Hand J, Aslam S, Haidar G, Malinis M, Santos CA, Schaenman J, Wojciechowski D, Ranganna K, Blumberg E, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Grabowski MK, Segev DL, Redd AD, Durand CM, Larman HB, Tobian AA; HOPE in Action investigators. Human antibody repertoire among kidney donors with and without HIV. JCI Insight. 2026 Mar 12;11(8):e203645. doi: 10.1172/jci.insight.203645. eCollection 2026 Apr 22.
PubMed 41817597Freercks R, Rodrigues M, Manning K, Heymann J, Kopp JB, Nagiah S, Rana M, Florman S, Friedman-Moraco R, Stock P, Gilbert A, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Haidar G, Malinis M, Santos CAQ, Schaenman J, Blumberg EA, Wojciechowski D, Odim J, Massie A, Selvan MT, Bagnasco S, Segev D, Tobian AAR, Muller E, Durand CM, Redd AD. APOL1 Genotype and Patient Outcomes in US and South African Transplant Recipients With HIV who Received Kidneys From Donors With HIV. Transplantation. 2026 Apr 1;110(4):e897-e904. doi: 10.1097/TP.0000000000005556. Epub 2025 Nov 17.
PubMed 41247466Durand CM, Massie A, Florman S, Liang T, Rana MM, Friedman-Moraco R, Gilbert A, Stock P, Mehta SA, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Aslam S, Malinis M, Haidar G, Small CB, Santos CAQ, Schaenman J, Baddley J, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Brown D, Ostrander D, Eby Y, Desai N, Naqvi F, Bagnasco S, Watson N, Brittain E, Odim J, Redd AD, Tobian AAR, Segev DL; HOPE in Action Investigators. Safety of Kidney Transplantation from Donors with HIV. N Engl J Med. 2024 Oct 17;391(15):1390-1401. doi: 10.1056/NEJMoa2403733.
PubMed 39413376Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS, Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG, Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G, Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M, Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action Investigators. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States. Clin Infect Dis. 2022 Jun 10;74(11):2010-2019. doi: 10.1093/cid/ciab743.
PubMed 34453519
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
- ClinicalTrials.gov ID
- NCT03500315
- Acronym / sponsor ID
- IRB00141138
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.
Detailed description
This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV D+/R+ | Experimental | Other: HIV D+/R+HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100 |
| HIV D-/R+ | No intervention | –HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100 |
| HIV D-/R+ (observational) | No intervention | –HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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+Kidney from an HIV-infected deceased donor | Other | HIV D+/R+ |
Primary outcome
Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection
Time frame: From date of transplant through administrative censorship at study completion, up to 4 years
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
30 secondary outcomes
Pre-transplant Mortality
Time frame: At 1 and 2 years post-consent, prior to transplant
Graft Failure
Time frame: At 1 and 3 years post transplant
Rate of Serious Adverse Events
Time frame: From date of transplant through graft failure or administrative censorship at study completion, up to year 4
6-month Acute Rejection
Time frame: At 6 months post-transplant
1-year Acute Rejection
Time frame: From date of transplant to end of year 1
Incidence of Graft Rejection
Time frame: At 1 and 3 years post transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Time frame: At 3 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Time frame: At 6 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Time frame: 9 months post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Time frame: At year 1 post-transplant
Graft Function Number of Participants With eGRF<60 mL/Min/1.73 m^2
Time frame: At year 2 post-transplant
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Time frame: At year 3 post-transplant
Graft Function -Mean eGFR
Time frame: 3 months post-transplant
Graft Function-mean eGFR
Time frame: 6 months post-transplant
Graft Function-mean eGFR
Time frame: 9 months post-transplant
Graft Function-mean eGFR
Time frame: 1 year post-transplant
Graft Function-mean eGFR
Time frame: 2 years post-transplant
Graft Function-mean eGFR
Time frame: 3 years post-transplant
Graft Function - Slope eGFR
Time frame: From date of transplant to end of follow-up, up to 4 years
Donor and Recipient Apolipoprotein L1 (APOL1)
Time frame: Baseline
Participants With Undetectable HIV RNA
Time frame: From date of transplant through end of follow-up, up to 4 years
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Time frame: From date of transplant through end of follow up, up to 4 years
Incidence of Antiretroviral Resistance
Time frame: From date of transplant through end of follow-up, up to 4 years
Incidence of X4 Tropic Virus
Time frame: From date of transplant through end of follow-up, up to 4 years
Incidence of Opportunistic Infection
Time frame: From date of transplant through end of follow-up, up to 4 years
Incidence of Surgical Complications
Time frame: From date of transplant through year 1
Incidence of Vascular Complications
Time frame: From date of transplant through year 1
Incidence of Viral-related Malignancies
Time frame: From date of transplant through end of follow-up, up to 4 years
Participants With Formation of de Novo Donor-specific Human Leukocyte Antigen(HLA) Antibodies
Time frame: From date of transplant through end of year 1
Composite Event, Cumulative Incidence
Time frame: At 6 months, 1 and 3 years post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41823991Sulaiman A, Tamil Selvan M, Yang P, Zhu X, Eby Y, Benner SE, Fernandez RE, Hussain S, Brown D, Desai N, Florman S, Rana MM, Friedman-Moraco R, Pereira MR, Mehta S, Stock P, Gilbert A, Morris MI, Stosor V, Mehta SA, Small CB, Ranganna K, Santos CAQ, Aslam S, Malinis M, Elias N, Blumberg EA, Massie A, Smith ML, Morsheimer M, Laird GM, Siliciano R, Segev DL, Durand CM, Redd AD, Tobian AA. Allograft Rejection and the Latent HIV Reservoir in Kidney Transplant Recipients with HIV. J Infect Dis. 2026 Mar 13:jiag154. doi: 10.1093/infdis/jiag154. Online ahead of print.
- Derived from this study: PubMed 41817597Zhu X, Morgenlander WR, Brown DM, Eby Y, Morsheimer M, Odim J, Bagnasco SM, Rana MM, Florman SS, Friedman-Moraco RJ, Stock PG, Gilbert AJ, Mehta S, Stosor V, Mehta SA, Pereira MR, Small CB, Morris MI, Hand J, Aslam S, Haidar G, Malinis M, Santos CA, Schaenman J, Wojciechowski D, Ranganna K, Blumberg E, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Grabowski MK, Segev DL, Redd AD, Durand CM, Larman HB, Tobian AA; HOPE in Action investigators. Human antibody repertoire among kidney donors with and without HIV. JCI Insight. 2026 Mar 12;11(8):e203645. doi: 10.1172/jci.insight.203645. eCollection 2026 Apr 22.
- Derived from this study: PubMed 41247466Freercks R, Rodrigues M, Manning K, Heymann J, Kopp JB, Nagiah S, Rana M, Florman S, Friedman-Moraco R, Stock P, Gilbert A, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Haidar G, Malinis M, Santos CAQ, Schaenman J, Blumberg EA, Wojciechowski D, Odim J, Massie A, Selvan MT, Bagnasco S, Segev D, Tobian AAR, Muller E, Durand CM, Redd AD. APOL1 Genotype and Patient Outcomes in US and South African Transplant Recipients With HIV who Received Kidneys From Donors With HIV. Transplantation. 2026 Apr 1;110(4):e897-e904. doi: 10.1097/TP.0000000000005556. Epub 2025 Nov 17.
- Derived from this study: PubMed 39413376Durand CM, Massie A, Florman S, Liang T, Rana MM, Friedman-Moraco R, Gilbert A, Stock P, Mehta SA, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Aslam S, Malinis M, Haidar G, Small CB, Santos CAQ, Schaenman J, Baddley J, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Brown D, Ostrander D, Eby Y, Desai N, Naqvi F, Bagnasco S, Watson N, Brittain E, Odim J, Redd AD, Tobian AAR, Segev DL; HOPE in Action Investigators. Safety of Kidney Transplantation from Donors with HIV. N Engl J Med. 2024 Oct 17;391(15):1390-1401. doi: 10.1056/NEJMoa2403733.
- Derived from this study: PubMed 34453519Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS, Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG, Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G, Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M, Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action Investigators. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States. Clin Infect Dis. 2022 Jun 10;74(11):2010-2019. doi: 10.1093/cid/ciab743.
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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. This study is not recruiting at the moment.
Christine Durand, MD principal investigator
Johns Hopkins University
29 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+ in people with Hiv, run by Johns Hopkins University at 29 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 13 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: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection (time frame: From date of transplant through administrative censorship at study completion, up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500315, which also lists 5 linked publications.
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 3 Sep 2026.