HIV InfectionNCT02602262
Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
An observational study of HIV Infection, run by Johns Hopkins University at 18 sites in United States.
Trial summary
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- HIV-infected deceased donor organ
- How many people
- 105 participants
- Where
- 18 sitesUnited States
- Study dates
- Nov 2015to 16 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
Who may be able to join
- All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
- Participant is able to understand and provide informed consent
- Participant meets standard listing criteria for transplant.
- Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).
- Participant is > 18 years old.
- Opportunistic Complications: None or previous history of protocol allowed opportunistic infections or neoplasms with appropriate acute and maintenance therapy and no evidence of active disease.
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- Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.
- Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL) should be < 50 copies, but this result can be documented outside the 16 week window according to the judgement of the local clinical team and site investigator. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen to be used by the recipient once organ function is restored after transplantation.
- Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.
Who cannot join
- Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
- Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.
- Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease free state for 2 years. History of leukemia and disease-free duration will be per site policy.
- Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per clinical practice. Women that become pregnant should not breastfeed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21205
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
Methodist Health System
Dallas, Texas, 75203
Indiana University
Indianapolis, Indiana, 46202
Yale University School of Medicine
New Haven, Connecticut, 06520
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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
Official title: Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.
Read the detailed description
This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.
In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.
- Conditions
- HIV Infection
- Being tested
- HIV-infected deceased donor organ
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-infected deceased donor organOther
HIV-infected deceased donor organ transplant
| Study group | Role | What they receive |
|---|---|---|
| HIV D+/R+ | HIV-infected individuals who accept an organ from an HIV-infected deceased donor Receives: Other: HIV-infected deceased donor organ | |
| HIV D-/R+ | HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient survival at one year
Measured: One year
Secondary outcomes (11)
Graft survival
Transplanted organ function
Measured: one year, two years, 3 years, 4 years
Graft rejection
Incidence and severity of organ rejection
Measured: One year
HIV disease progression
Incidence of virologic breakthrough or failure
Measured: through study completion, up to 4 years
Antiretroviral resistance and X4 tropic virus
incidence of new antiretroviral drug resistance and/or X4 tropic virus
Measured: through study completion, up to 4 years
Incidence of bacterial, fungal, viral, and other opportunistic infection
incidence of bacterial, fungal, viral, and other opportunistic infections
Measured: through study completion, up to 4 years
Surgical complications
incidence of surgical and vascular transplant complications
Measured: within the first 3 months
Recurrent HIV-associated nephropathy
incidence of recurrent HIV-associated nephropathy in kidney recipients
Measured: through study completion, up to 4 years
Incidence of post-transplant Malignancy
incidence of post-transplant malignancies
Measured: through study completion, up to 4 years
Incidence of HIV superinfection in blood and/or tissue
Incidence of HIV superinfection in blood and/or tissue
Measured: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
HIV latent reservoir
Frequency of infected CD4 T cells in blood
Measured: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Immune activation
Cytokine levels
Measured: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion12 Jun 2020
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Yale University, Georgetown University, Emory University, Rush University Medical Center, University of Illinois Chicago, Indiana University, University of Maryland, Columbia University, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, University of Pittsburgh Medical Center, Methodist Health System, Northwestern University, NYU Langone Health, University of Virginia, Washington University School of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Christine Durand, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602262
- Sponsor's protocol ID
- IRB00085148
- Other IDs
- JHUHIVDD, 1U01AI134591-01
- Status last verified
- Aug 2025
- First submitted
- 6 Nov 2015
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arant EC, Davy-Mendez T, Liang T, Rodrigues M, Gay CL, 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 JW, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Morsheimer M, van Delden C, Manuel O, Mueller NJ, Neofyotos D, Tobian AAR, Massie A, Segev DL, Werbel W, Durand CM. Infections After Kidney Transplantation From Donors With HIV to Recipients With HIV. Clin Infect Dis. 2026 Mar 17;82(3):e549-e557. doi: 10.1093/cid/ciaf656.
PubMed 41524130Benner SE, Zhu X, Hussain S, Florman S, Eby Y, Fernandez RE, Ostrander D, Rana M, Ottmann S, Hand J, Price JC, Pereira MR, Wojciechowski D, Simkins J, Stosor V, Mehta SA, Aslam S, Malinis M, Haidar G, Massie A, Smith ML, Odim J, Morsheimer M, Quinn TC, Laird GM, Siliciano R, Balagopal A, Segev DL, Durand CM, Redd AD, Tobian AAR. HIV-Positive Liver Transplant Does not Alter the Latent Viral Reservoir in Recipients With Antiretroviral Therapy-Suppressed HIV. J Infect Dis. 2023 Nov 2;228(9):1274-1279. doi: 10.1093/infdis/jiad241.
PubMed 37379584Werbel 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 34453519Bonny TS, Kirby C, Martens C, Rose R, Desai N, Seisa M, Petropoulos C, Florman S, Friedman-Moraco RJ, Turgeon NA, Brown D, Segev DL, Durand CM, Tobian AAR, Redd AD. Outcomes of donor-derived superinfection screening in HIV-positive to HIV-positive kidney and liver transplantation: a multicentre, prospective, observational study. Lancet HIV. 2020 Sep;7(9):e611-e619. doi: 10.1016/S2352-3018(20)30200-9. Epub 2020 Jul 27.
PubMed 32730756
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients
- ClinicalTrials.gov ID
- NCT02602262
- Acronym / sponsor ID
- IRB00085148
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Yale University, Georgetown University, Emory University, Rush University Medical Center, University of Illinois Chicago, Indiana University, University of Maryland, Columbia University, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, University of Pittsburgh Medical Center, Methodist Health System, Northwestern University, NYU Langone Health, University of Virginia, Washington University School of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2015 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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.
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.
Detailed description
This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.
In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV D+/R+ | – | Other: HIV-infected deceased donor organHIV-infected individuals who accept an organ from an HIV-infected deceased donor |
| HIV D-/R+ | – | –HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
Key inclusion criteria (9 listed)
- All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.
- Participant is able to understand and provide informed consent
- Participant meets standard listing criteria for transplant.
- Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).
- Participant is > 18 years old.
Key exclusion criteria (4 listed)
- Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
- Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.
- Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease free state for 2 years. History of leukemia and disease-free duration will be per site policy.
- Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per clinical practice. Women that become pregnant should not breastfeed.
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-infected deceased donor organHIV-infected deceased donor organ transplant | Other | HIV D+/R+ |
Primary outcome
Survival
Time frame: One year
Patient survival at one year
11 secondary outcomes
Graft survival
Time frame: one year, two years, 3 years, 4 years
Graft rejection
Time frame: One year
HIV disease progression
Time frame: through study completion, up to 4 years
Antiretroviral resistance and X4 tropic virus
Time frame: through study completion, up to 4 years
Incidence of bacterial, fungal, viral, and other opportunistic infection
Time frame: through study completion, up to 4 years
Surgical complications
Time frame: within the first 3 months
Recurrent HIV-associated nephropathy
Time frame: through study completion, up to 4 years
Incidence of post-transplant Malignancy
Time frame: through study completion, up to 4 years
Incidence of HIV superinfection in blood and/or tissue
Time frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
HIV latent reservoir
Time frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Immune activation
Time frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 41524130Arant EC, Davy-Mendez T, Liang T, Rodrigues M, Gay CL, 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 JW, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Morsheimer M, van Delden C, Manuel O, Mueller NJ, Neofyotos D, Tobian AAR, Massie A, Segev DL, Werbel W, Durand CM. Infections After Kidney Transplantation From Donors With HIV to Recipients With HIV. Clin Infect Dis. 2026 Mar 17;82(3):e549-e557. doi: 10.1093/cid/ciaf656.
- Derived from this study: PubMed 37379584Benner SE, Zhu X, Hussain S, Florman S, Eby Y, Fernandez RE, Ostrander D, Rana M, Ottmann S, Hand J, Price JC, Pereira MR, Wojciechowski D, Simkins J, Stosor V, Mehta SA, Aslam S, Malinis M, Haidar G, Massie A, Smith ML, Odim J, Morsheimer M, Quinn TC, Laird GM, Siliciano R, Balagopal A, Segev DL, Durand CM, Redd AD, Tobian AAR. HIV-Positive Liver Transplant Does not Alter the Latent Viral Reservoir in Recipients With Antiretroviral Therapy-Suppressed HIV. J Infect Dis. 2023 Nov 2;228(9):1274-1279. doi: 10.1093/infdis/jiad241.
- 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.
- Derived from this study: PubMed 32730756Bonny TS, Kirby C, Martens C, Rose R, Desai N, Seisa M, Petropoulos C, Florman S, Friedman-Moraco RJ, Turgeon NA, Brown D, Segev DL, Durand CM, Tobian AAR, Redd AD. Outcomes of donor-derived superinfection screening in HIV-positive to HIV-positive kidney and liver transplantation: a multicentre, prospective, observational study. Lancet HIV. 2020 Sep;7(9):e611-e619. doi: 10.1016/S2352-3018(20)30200-9. Epub 2020 Jul 27.
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, 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 9 inclusion and 4 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 14 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival (time frame: One year). 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 NCT02602262, which also lists 4 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 14 Aug 2025.