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HivNCT03734393

HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

A study testing HIVD+/R+ in people with Hiv, run by Johns Hopkins University at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to determine if an HIV-infected donor liver (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?
HIVD+/R+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
26 sitesUnited States
Study dates
4 Jan 2019to 4 Jul 2025
Phase
Interventional
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

Who may be able to join

  • Participant meets the standard criteria for liver transplant at the local center.
  • Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs.
  • Participant is able to understand and provide informed consent.
  • Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria.
  • Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).*
  • Participant is ≥ 18 years old.
Show all 15Show fewer
  • Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.
  • CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.
  • HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who are unable to tolerate anti-retroviral therapy (ART) due to organ.
  • failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
  • Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
  • Participant is willing to comply with all medications related to participant's transplant and HIV management.
  • For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease.
  • Agreement to use contraception.
  • 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. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
  • 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

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland, Institute of Human Virology

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • 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

  • 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 Tennessee Health and Science Center

    Memphis, Tennessee, 38104

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8022

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • 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

  • New York University School of Medicine

    New York, New York, 11016

  • 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

Other trials in United States

About this study

Official title: HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

The primary objective of this study is to determine if an HIV-infected donor liver (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 liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a liver from an HIV-uninfected deceased liver 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
HIVD+/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.

  • HIVD+/R+Other

    Liver from an HIV-infected deceased donor

Study groups in NCT03734393
Study groupRoleWhat they receive
HIV D+/R+ExperimentalHIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40
Receives: Other: HIVD+/R+
HIVD-/R+No interventionHIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and are randomized to participate in the full study arm, which includes research sample collection -enrollment 40
HIVD-/R+ (observational)No interventionHIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure

    Time (in days) to first of any of the following events: death or graft failure or SAE or HIV breakthrough or opportunistic infection

    Measured: From date of transplant through administrative censorship at study completion, up to 4 years

Secondary outcomes (57)

  1. Time to Pre-transplant mortality

    Time (in days) to mortality while enrolled before transplant (survival framework)

    Measured: From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years

  2. Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis

    Time (in days) to mortality or re-transplant or return to maintenance dialysis (survival framework)

    Measured: From date of transplant through administrative censorship at study completion, up to 4 years

  3. 1-year acute liver rejection

    Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.

    Measured: From date of transplant to end of year 1

  4. 2-year acute liver rejection

    Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.

    Measured: From date of transplant to end of year 2

  5. 3-year acute liver rejection

    Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.

    Measured: From date of transplant to end of year 3

  6. Number of graft rejections in liver transplant

    Cumulative incidence of acute rejection (survival framework) as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.

    Measured: From date of transplant to end of year 3

  7. 6-month acute kidney rejection in simultaneous liver/kidney transplant recipients

    Proportion 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)

    Measured: From date of transplant to 6 months post transplant

  8. 1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only

    Proportion 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)

    Measured: From date of transplant to end of year 1

  9. Number of Non-alcoholic fatty liver (NAFL)

    Cumulative incidence of NAFL as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis

    Measured: From date of transplant through end of follow-up, up to 3 years

  10. Number of steatohepatitis (NASH)

    Cumulative incidence of NASH as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis

    Measured: From date of transplant through end of follow-up, up to 3 years

  11. Trajectory of recipient Cluster of Differentiation (CD4) count over time

    Analysis of repeated measures of CD4 (cells/mm3) count (longitudinal model)

    Measured: From date of transplant through end of follow up, up to 4 years

  12. Trajectory of recipient plasma HIV RNA over time

    Analysis of repeated measures of plasma HIV RNA (copies/mL) longitudinal model

    Measured: From date of transplant through end of follow-up, up to 4 years

  13. Graft function as assessed by Fibrosis-4 index

    Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.

    Measured: 1 years post-transplant

  14. Graft function as assessed by Fibrosis-4 index

    Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.

    Measured: 2 years post-transplant

  15. Graft function as assessed by Fibrosis-4 index

    Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.

    Measured: 3 years post-transplant

  16. Graft function as assessed by Fibrosis-4 index

    Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.

    Measured: 4 years post-transplant

  17. Graft function as assessed by incidence of fibrosis

    Cumulative incidence of advanced fibrosis (stage F3 or greater as defined by metavir fibrosis score) as measured on biopsy. The fibrosis score is assessed on a five point scale (F0 = no fibrosis, F1 = portal fibrosis without septa, F2 = few septa, F3 = numerous septa without cirrhosis, F4 = cirrhosis).

    Measured: From date of transplant through end of follow-up, up to 3 years

  18. Graft function as assessed by liver stiffness

    Mean calculated liver stiffness by transient elastography (kPA)

    Measured: 1 year post-transplant

  19. Graft function as assessed by liver stiffness

    Mean calculated liver stiffness by transient elastography (kPA)

    Measured: 2 years post-transplant

  20. Graft function as assessed by liver stiffness

    Mean calculated liver stiffness by transient elastography (kPA)

    Measured: 3 years post-transplant

  21. Average graft function as assessed by aspartate aminotransferase (AST)

    Mean calculated AST (U/L)

    Measured: 1 year post-transplant

  22. Average graft function as assessed by AST

    Mean calculated AST (U/L)

    Measured: 2 years post-transplant

  23. Average graft function as assessed by AST

    Mean calculated AST (U/L)

    Measured: 3 years post-transplant

  24. Average graft function as assessed by AST

    Mean calculated AST (U/L)

    Measured: 4 years post-transplant

  25. Average graft function as assessed by alanine aminotransferase (ALT)

    Mean calculated ALT (U/L)

    Measured: 1 year post-transplant

  26. Average graft function as assessed by ALT

    Mean calculated ALT (U/L)

    Measured: 2 years post-transplant

  27. Average Graft function as assessed by ALT

    Mean calculated ALT (U/L)

    Measured: 3 years post-transplant

  28. Average graft function as assessed by ALT

    Mean calculated ALT (U/L)

    Measured: 4 years post-transplant

  29. Average graft function as assessed by bilirubin

    Mean calculated bilirubin (mg/dL)

    Measured: 1 year post-transplant

  30. Average graft function as assessed by bilirubin

    Mean calculated bilirubin (mg/dL)

    Measured: 2 years post-transplant

  31. Average graft function as assessed by bilirubin

    Mean calculated bilirubin (mg/dL)

    Measured: 3 years post-transplant

  32. Average graft function as assessed by Bilirubin

    Mean calculated bilirubin (mg/dL)

    Measured: 4 years post-transplant

  33. Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score

    Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease

    Measured: 1 year post-transplant

  34. Graft function as assessed by Mean calculated MELD score

    Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease

    Measured: 2 years post-transplant

  35. Graft function as assessed by Mean calculated MELD score

    Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease

    Measured: 3 years post-transplant

  36. Graft function as assessed by Mean calculated MELD score

    Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease

    Measured: 4 years post-transplant

  37. Graft function as assessed by AST to Platelet Ratio (APRI) index

    Mean calculated APRI index [( AST / upper limits of normal (ULN) AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.

    Measured: 1 year post-transplant

  38. Graft function as assessed by AST to Platelet Ratio (APRI) index

    Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.

    Measured: 2 years post-transplant

  39. Graft function as assessed by AST to Platelet Ratio (APRI) index

    Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.

    Measured: 3 years post-transplant

  40. Graft function as assessed by AST to Platelet Ratio (APRI) index

    Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.

    Measured: 4 years post-transplant

  41. Metabolic Outcome as assessed by Body mass index (BMI)

    Mean calculated BMI (weight in kilograms/height in meters squared)

    Measured: 1 year post-transplant

  42. Metabolic Outcome as assessed by Body mass index (BMI)

    Mean calculated BMI(weight in kilograms/height in meters squared)

    Measured: 2 years post-transplant

  43. Metabolic Outcome as assessed by Body mass index (BMI)

    Mean calculated BMI(weight in kilograms/height in meters squared)

    Measured: 3 years post-transplant

  44. Metabolic Outcome as assessed by Body mass index (BMI)

    Mean calculated BMI(weight in kilograms/height in meters squared)

    Measured: 4 years post-transplant

  45. Average hemoglobin a1c among participants at 1 year

    Mean calculated hemoglobin a1c (mg/dL)

    Measured: 1 years post-transplant

  46. Average hemoglobin a1c among participants at 2 years

    Mean calculated hemoglobin a1c (mg/dL)

    Measured: 2 years post-transplant

  47. Average hemoglobin a1c among participants at 3 years

    Mean calculated hemoglobin a1c (mg/dL)

    Measured: 3 years post-transplant

  48. Average hemoglobin a1c among participants at 4 years

    Mean calculated hemoglobin a1c (mg/dL)

    Measured: 4 years post-transplant

  49. Number of HIV breakthroughs

    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

  50. Number of opportunistic infections

    Cumulative incidence of opportunistic infections

    Measured: From date of transplant through end of follow-up, up to 4 years

  51. Number of X4 tropic virus breakthroughs

    Measured by sending virus at time of breakthrough for HIV co-receptor assay

    Measured: From date of transplant through end of follow-up, up to 4 years

  52. Number of vascular complications

    Number of vascular complications within 1 year of transplant, e.g. thrombosis, aneurysm

    Measured: From date of transplant through year 1

  53. Number 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

  54. Number 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

  55. Hepatitis C (HCV) sustained viral response post-transplant

    Proportion of HCV RNA positive recipients that achieve a sustained virologic response week 12 post-treatment (<15 IU/mL) with direct acting antivirals

    Measured: 12 weeks HCV treatment

  56. Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies

    Proportion of participants with a de novo donor-specific HLA antibody as measured and reported by local sites' lab

    Measured: From date of transplant through end of year 1

  57. Time to first occurrence of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness as a composite measure

    Time to first of any of these events: all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness

    Measured: From date of transplant through end of follow-up, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start4 Jan 2019
  3. Primary completion4 Jul 2025
  4. Study completion4 Jul 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03734393
Sponsor's protocol ID
IRB00194582
Other IDs
U01AI138897
Status last verified
Jul 2026
First submitted
6 Nov 2018
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Benner 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 37379584

  • Werbel 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

Questions about this trial

What is this clinical trial studying?

A study testing HIVD+/R+ in people with Hiv, run by Johns Hopkins University at 26 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 15 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure (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 NCT03734393, which also lists 2 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 20 Jul 2026.

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