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

• ClinicalTrials.gov Identifier: NCT03734393
• Recruitment Status: Recruiting
• First Posted: November 8, 2018
• Last Update Posted: May 5, 2022
• Sponsor: Johns Hopkins University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Hiv	Other: HIVD+/R+	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
• Actual Study Start Date: January 4, 2019
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: HIV D+/R+; HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40	Other: HIVD+/R+; Liver from an HIV-infected deceased donor
No Intervention: HIVD-/R+; HIV-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
No Intervention: HIVD-/R+ (observational); HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Time (in days) to first of any of the following events: death or graft failure or SAE or HIV breakthrough or opportunistic infection

Secondary Outcome Measures :

1. Time to Pre-transplant mortality [ Time Frame: From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years ]
   Time (in days) to mortality while enrolled before transplant (survival framework)
2. Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis [ Time Frame: From date of transplant through administrative censorship at study completion, up to 4 years ]
   Time (in days) to mortality or re-transplant or return to maintenance dialysis (survival framework)
3. 1-year acute liver rejection [ Time Frame: From date of transplant to end of year 1 ]
   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.
4. 2-year acute liver rejection [ Time Frame: From date of transplant to end of year 2 ]
   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.
5. 3-year acute liver rejection [ Time Frame: From date of transplant to end of year 3 ]
   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.
6. Number of graft rejections in liver transplant [ Time Frame: From date of transplant to end of year 3 ]
   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.
7. 6-month acute kidney rejection in simultaneous liver/kidney transplant recipients [ Time Frame: From date of transplant to 6 months post transplant ]
   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)
8. 1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only [ Time Frame: From date of transplant to end of year 1 ]
   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)
9. Number of Non-alcoholic fatty liver (NAFL) [ Time Frame: From date of transplant through end of follow-up, up to 3 years ]
   Cumulative incidence of NAFL as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
10. Number of steatohepatitis (NASH) [ Time Frame: From date of transplant through end of follow-up, up to 3 years ]
    Cumulative incidence of NASH as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
11. 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 ]
    Analysis of repeated measures of CD4 (cells/mm3) count (longitudinal model)
12. Trajectory of recipient plasma HIV RNA over time [ Time Frame: From date of transplant through end of follow-up, up to 4 years ]
    Analysis of repeated measures of plasma HIV RNA (copies/mL) longitudinal model
13. Graft function as assessed by Fibrosis-4 index [ Time Frame: 1 years post-transplant ]
    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.
14. Graft function as assessed by Fibrosis-4 index [ Time Frame: 2 years post-transplant ]
    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.
15. Graft function as assessed by Fibrosis-4 index [ Time Frame: 3 years post-transplant ]
    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.
16. Graft function as assessed by Fibrosis-4 index [ Time Frame: 4 years post-transplant ]
    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.
17. Graft function as assessed by incidence of fibrosis [ Time Frame: From date of transplant through end of follow-up, up to 3 years ]
    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).
18. Graft function as assessed by liver stiffness [ Time Frame: 1 year post-transplant ]
    Mean calculated liver stiffness by transient elastography (kPA)
19. Graft function as assessed by liver stiffness [ Time Frame: 2 years post-transplant ]
    Mean calculated liver stiffness by transient elastography (kPA)
20. Graft function as assessed by liver stiffness [ Time Frame: 3 years post-transplant ]
    Mean calculated liver stiffness by transient elastography (kPA)
21. Average graft function as assessed by aspartate aminotransferase (AST) [ Time Frame: 1 year post-transplant ]
    Mean calculated AST (U/L)
22. Average graft function as assessed by AST [ Time Frame: 2 years post-transplant ]
    Mean calculated AST (U/L)
23. Average graft function as assessed by AST [ Time Frame: 3 years post-transplant ]
    Mean calculated AST (U/L)
24. Average graft function as assessed by AST [ Time Frame: 4 years post-transplant ]
    Mean calculated AST (U/L)
25. Average graft function as assessed by alanine aminotransferase (ALT) [ Time Frame: 1 year post-transplant ]
    Mean calculated ALT (U/L)
26. Average graft function as assessed by ALT [ Time Frame: 2 years post-transplant ]
    Mean calculated ALT (U/L)
27. Average Graft function as assessed by ALT [ Time Frame: 3 years post-transplant ]
    Mean calculated ALT (U/L)
28. Average graft function as assessed by ALT [ Time Frame: 4 years post-transplant ]
    Mean calculated ALT (U/L)
29. Average graft function as assessed by bilirubin [ Time Frame: 1 year post-transplant ]
    Mean calculated bilirubin (mg/dL)
30. Average graft function as assessed by bilirubin [ Time Frame: 2 years post-transplant ]
    Mean calculated bilirubin (mg/dL)
31. Average graft function as assessed by bilirubin [ Time Frame: 3 years post-transplant ]
    Mean calculated bilirubin (mg/dL)
32. Average graft function as assessed by Bilirubin [ Time Frame: 4 years post-transplant ]
    Mean calculated bilirubin (mg/dL)
33. Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score [ Time Frame: 1 year post-transplant ]
    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
34. Graft function as assessed by Mean calculated MELD score [ Time Frame: 2 years post-transplant ]
    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
35. Graft function as assessed by Mean calculated MELD score [ Time Frame: 3 years post-transplant ]
    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
36. Graft function as assessed by Mean calculated MELD score [ Time Frame: 4 years post-transplant ]
    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
37. Graft function as assessed by AST to Platelet Ratio (APRI) index [ Time Frame: 1 year post-transplant ]
    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.
38. Graft function as assessed by AST to Platelet Ratio (APRI) index [ Time Frame: 2 years post-transplant ]
    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.
39. Graft function as assessed by AST to Platelet Ratio (APRI) index [ Time Frame: 3 years post-transplant ]
    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.
40. Graft function as assessed by AST to Platelet Ratio (APRI) index [ Time Frame: 4 years post-transplant ]
    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.
41. Metabolic Outcome as assessed by Body mass index (BMI) [ Time Frame: 1 year post-transplant ]
    Mean calculated BMI (weight in kilograms/height in meters squared)
42. Metabolic Outcome as assessed by Body mass index (BMI) [ Time Frame: 2 years post-transplant ]
    Mean calculated BMI(weight in kilograms/height in meters squared)
43. Metabolic Outcome as assessed by Body mass index (BMI) [ Time Frame: 3 years post-transplant ]
    Mean calculated BMI(weight in kilograms/height in meters squared)
44. Metabolic Outcome as assessed by Body mass index (BMI) [ Time Frame: 4 years post-transplant ]
    Mean calculated BMI(weight in kilograms/height in meters squared)
45. Average hemoglobin a1c among participants at 1 year [ Time Frame: 1 years post-transplant ]
    Mean calculated hemoglobin a1c (mg/dL)
46. Average hemoglobin a1c among participants at 2 years [ Time Frame: 2 years post-transplant ]
    Mean calculated hemoglobin a1c (mg/dL)
47. Average hemoglobin a1c among participants at 3 years [ Time Frame: 3 years post-transplant ]
    Mean calculated hemoglobin a1c (mg/dL)
48. Average hemoglobin a1c among participants at 4 years [ Time Frame: 4 years post-transplant ]
    Mean calculated hemoglobin a1c (mg/dL)
49. Number of HIV breakthroughs [ Time Frame: From date of transplant through end of follow-up, up to 4 years ]
    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
50. Number of opportunistic infections [ Time Frame: From date of transplant through end of follow-up, up to 4 years ]
    Cumulative incidence of opportunistic infections
51. Number of X4 tropic virus breakthroughs [ Time Frame: From date of transplant through end of follow-up, up to 4 years ]
    Measured by sending virus at time of breakthrough for HIV co-receptor assay
52. Number of vascular complications [ Time Frame: From date of transplant through year 1 ]
    Number of vascular complications within 1 year of transplant, e.g. thrombosis, aneurysm
53. Number of surgical complications [ Time Frame: From date of transplant through year 1 ]
    Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
54. Number of viral-related malignancies [ Time Frame: From date of transplant through end of follow-up, up to 4 years ]
    Number of malignancies as determined by local pathology
55. Hepatitis C (HCV) sustained viral response post-transplant [ Time Frame: 12 weeks HCV treatment ]
    Proportion of HCV RNA positive recipients that achieve a sustained virologic response week 12 post-treatment (<15 IU/mL) with direct acting antivirals
56. Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies [ Time Frame: From date of transplant through end of year 1 ]
    Proportion of participants with a de novo donor-specific HLA antibody as measured and reported by local sites' lab
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 Frame: From date of transplant through end of follow-up, up to 4 years ]
    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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Contacts

Contact: Christine Durand, MD; 410-955-5684; cdurand2@jhmi.edu

Contact: Dorry Segev, MD, PhD; 410-502-6115; dorry.segev@nyulangone.org

Locations

United States, Alabama

University of Alabama, Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Babak Orandi, MD borandi@uabmc.edu

Contact: Katherine Miller, RN, CCRP katherinemiller@uabmc.edu

Principal Investigator: Babak Orandi, MD

United States, Arkansas

University of Arkansas for Medical Sciences; Recruiting

Little Rock, Arkansas, United States, 72205

Contact: Emmanouil Giorgakis, MD egiorgakis@uams.edu

Contact: Pamela Buckner, BSN, RN, CPN 501-603-1074 pbuckner@uams.edu

Principal Investigator: Emmanouil Giorgakis, MD

United States, California

University of California, San Diego; Recruiting

San Diego, California, United States, 92103

Contact: Saima Aslam, MD saslam@ucsd.edu

Contact: Phirum Nguyen, BS 858-822-3108 psnguyen@ucsd.edu

Principal Investigator: Saima Aslam, MD

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94193

Contact: Jennifer Price, MD jennifer.price@ucsf.edu

Contact: Yanin Srisengfa tab.srisengfa@ucsf.edu

Principal Investigator: Jennifer Price, MD

United States, Connecticut

Yale University School of Medicine; Recruiting

New Haven, Connecticut, United States, 06520-8022

Contact: Maricar Malinis, MD 203-785-3561 maricar.malinis@yale.edu

Contact: Ricarda Tomlin, BS, CCRP 203-785-2073 ricarda.tomlin@yale.edu

Principal Investigator: Maricar Malinis, MD

United States, District of Columbia

MedStar Georgetown Transplant Institute; Recruiting

Washington, District of Columbia, United States, 20007

Contact: Coleman Smith, MD coleman.i.smith@gunet.georgetown.edu

Contact: Rochell Yacat Rochell.Yacat@gunet.georgetown.edu

Principal Investigator: Coleman Smith, MD

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Contact: Jacque Simkins-Cohen, MD jsimkins@med.miami.edu

Principal Investigator: Jacque Simkins-Cohen, MD

United States, Georgia

Emory University; Recruiting

Atlanta, Georgia, United States, 30322

Contact: William H. Kitchens Jr., MD, PhD 404-727-8196 william.henry.kitchens.jr@emory.edu

Contact: Jeryl Huckaby, MSCRA, CCRC jhuckab@emory.edu

Principal Investigator: William H. Kitchens Jr., MD, PhD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Valentina Stosor, MD 312-695-5085 v-stosor@morthwestern.edu

Contact: Leah Goudy, RN leah.goudy@northwestern.edu

Principal Investigator: Valentina Stosor, MD

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: Carlos A Santos, MD Carlos_A_Santos@rush.edu

Contact: Mark Mall Mark_Mall@rush.edu

Principal Investigator: Carlos A Santos, MD

University of Illinois at Chicago; Recruiting

Chicago, Illinois, United States, 60612

Contact: Mario Spaggiari, MD 312-675-9570 mspaggia@uic.edu

Contact: Kelly Bruno kbruno@uic.edu

Principal Investigator: Mario Spaggiari, MD

United States, Indiana

Indiana University; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Chandrashekhar Kubal, MD, PhD sakubal@iupui.edu

Contact: Jennifer Lehman jgeck@iu.edu

Principal Investigator: Chandrashekhar Kubal, MD, PhD

United States, Louisiana

Ochsner Clinic Foundation; Recruiting

New Orleans, Louisiana, United States, 70121

Contact: Jonathan Hand, MD jonathan.hand@ochsner.org

Contact: Angela R. Smith 504-703-2061 anglsmith@ochsner.org

Principal Investigator: Jonathan Hand, MD

United States, Maryland

University of Maryland, Institute of Human Virology; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Jennifer Husson, MD, MPH 410-706-8614 jhusson@ihv.umaryland.edu

Contact: Ka Wing Joyce Lam jlam@ihv.umaryland.edu

Principal Investigator: Jennifer Husson, MD, MPH

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21205

Contact: Christine Durand, MD 410-955-5684 cdurand2@jhmi.edu

Contact: Magaly Rodriguez, RN mrodri57@jhu.edu

Principal Investigator: Christine Durand, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Nahel Elias, MD 617-726-0174 elias.nahel@mgh.harvard.edu

Contact: Margaret Thomas Mutty, BS 617-643-6266 mvthomas@mgh.harvard.edu

Principal Investigator: Nahel Elias, MD

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Timothy Pruett, MD tlpruett@umn.edu

Contact: Michelle Landweer mland@umn.edu

Principal Investigator: Timothy Pruett, MD

United States, New York

Icahn School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

Contact: Sander Florman, MD 212-659-8313 sander.florman@mountsinai.org

Contact: Brandy Haydel 212-241-0255 brandy.haydel@mountsinai.org

Principal Investigator: Sander Florman, MD

Columbia University Medical Center; Recruiting

New York, New York, United States, 10032

Contact: Marcus Pereira, MD, MPH 212-305-3839 mp2323@cumc.columbia.edu

Contact: Dominique Piquant dp2997@cumc.columbia.edu

Principal Investigator: Marcus Pereira, MD, MPH

Weill Cornell Medical College; Recruiting

New York, New York, United States, 10065

Contact: Catherine Small, MD cbs9003@med.cornell.edu

Contact: Elizabeth Salsgiver els7021@med.cornell.edu

Principal Investigator: Catherine Small, MD

New York University School of Medicine; Recruiting

New York, New York, United States, 11016

Contact: Sapna Mehta, MD 646-754-1006 sapna.mehta@nyumc.org

Contact: Rebecca Dieter, PharmD rebecca.dieter@nyulangone.org

Principal Investigator: Sapna Mehta, MD

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45267

Contact: Senu Apewokin, MD 513-558-4253 apewoksu@ucmail.uc.edu

Contact: Samantha Kramer kramers5@ucmail.uc.edu

Principal Investigator: Senu Apewokin, MD

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Emily Blumberg, MD 215-662-7066 blumbere@pennmedicine.upenn.edu

Contact: Maryann Najdzinowicz, RN maryann.najdzinowicz@pennmedicine.upenn.edu

Principal Investigator: Emily Blumberg, MD

UPMC - University of Pittsburgh Medical Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Ghady Haidar, MD 412-648-6212 haidarg@upmc.edu

Contact: Kailey Hughes 412-648-6453 hugheskl4@upmc.edu

Principal Investigator: Ghady Haidar, MD

United States, Tennessee

University of Tennessee Health and Science Center; Recruiting

Memphis, Tennessee, United States, 38104

Contact: Vasanthi Balarman, MD vbalara1@uthsc.edu

Contact: Quentin Youngman qthacker@uthsc.edu

Principal Investigator: Vasanthi Balarman, MD

United States, Texas

University of Texas Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

Contact: David Wojciechowski, DO David.Wojciechowski@UTSouthwestern.edu

Contact: Witney Baah witney.baah@utsouthwestern.edu

Principal Investigator: David Wojciechowski, DO

Sponsors and Collaborators

Johns Hopkins University

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Christine Durand, MD; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03734393
• Other Study ID Numbers: IRB00194582; U01AI138897 ( U.S. NIH Grant/Contract )
• First Posted: November 8, 2018
• Last Update Posted: May 5, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Death; Pathologic Processes