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

Primary Purpose

Hiv

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIVD+/R+
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiv

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama, BirminghamRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • University of California, San DiegoRecruiting
  • University of California, San FranciscoRecruiting
  • Yale University School of MedicineRecruiting
  • MedStar Georgetown Transplant InstituteRecruiting
  • University of MiamiRecruiting
  • Emory UniversityRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • University of Illinois at ChicagoRecruiting
  • Indiana UniversityRecruiting
  • Ochsner Clinic FoundationRecruiting
  • University of Maryland, Institute of Human VirologyRecruiting
  • Johns Hopkins UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • University of MinnesotaRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Columbia University Medical CenterRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • New York University School of MedicineRecruiting
  • University of CincinnatiRecruiting
  • University of PennsylvaniaRecruiting
  • UPMC - University of Pittsburgh Medical CenterRecruiting
  • University of Tennessee Health and Science CenterRecruiting
  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

HIV D+/R+

HIVD-/R+

HIVD-/R+ (observational)

Arm Description

HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40

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

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Pre-transplant mortality
Time (in days) to mortality while enrolled before transplant (survival framework)
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)
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.
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.
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.
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.
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)
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)
Number of Non-alcoholic fatty liver (NAFL)
Cumulative incidence of NAFL as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Number of steatohepatitis (NASH)
Cumulative incidence of NASH as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Analysis of repeated measures of CD4 (cells/mm3) count (longitudinal model)
Trajectory of recipient plasma HIV RNA over time
Analysis of repeated measures of plasma HIV RNA (copies/mL) longitudinal model
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.
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.
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.
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.
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).
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Average graft function as assessed by aspartate aminotransferase (AST)
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by alanine aminotransferase (ALT)
Mean calculated ALT (U/L)
Average graft function as assessed by ALT
Mean calculated ALT (U/L)
Average Graft function as assessed by ALT
Mean calculated ALT (U/L)
Average graft function as assessed by ALT
Mean calculated ALT (U/L)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by Bilirubin
Mean calculated bilirubin (mg/dL)
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
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
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
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
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.
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.
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.
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.
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI (weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Average hemoglobin a1c among participants at 1 year
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 2 years
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 3 years
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 4 years
Mean calculated hemoglobin a1c (mg/dL)
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
Number of opportunistic infections
Cumulative incidence of opportunistic infections
Number of X4 tropic virus breakthroughs
Measured by sending virus at time of breakthrough for HIV co-receptor assay
Number of vascular complications
Number of vascular complications within 1 year of transplant, e.g. thrombosis, aneurysm
Number of surgical complications
Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Number of viral-related malignancies
Number of malignancies as determined by local pathology
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
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
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

Full Information

First Posted
November 6, 2018
Last Updated
May 8, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03734393
Brief Title
HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Official Title
HOPE in Action Prospective Multicenter, Clinical Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV D+/R+
Arm Type
Experimental
Arm Description
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 40
Arm Title
HIVD-/R+
Arm Type
No Intervention
Arm Description
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
Arm Title
HIVD-/R+ (observational)
Arm Type
No Intervention
Arm Description
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group with limited data collection - enrollment 120
Intervention Type
Other
Intervention Name(s)
HIVD+/R+
Intervention Description
Liver from an HIV-infected deceased donor
Primary Outcome Measure Information:
Title
Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure
Description
Time (in days) to first of any of the following events: death or graft failure or SAE or HIV breakthrough or opportunistic infection
Time Frame
From date of transplant through administrative censorship at study completion, up to 4 years
Secondary Outcome Measure Information:
Title
Time to Pre-transplant mortality
Description
Time (in days) to mortality while enrolled before transplant (survival framework)
Time Frame
From date of enrollment to date of transplant or death of any cause, whichever comes first, assessed up to 4 years
Title
Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis
Description
Time (in days) to mortality or re-transplant or return to maintenance dialysis (survival framework)
Time Frame
From date of transplant through administrative censorship at study completion, up to 4 years
Title
1-year acute liver rejection
Description
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.
Time Frame
From date of transplant to end of year 1
Title
2-year acute liver rejection
Description
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.
Time Frame
From date of transplant to end of year 2
Title
3-year acute liver rejection
Description
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.
Time Frame
From date of transplant to end of year 3
Title
Number of graft rejections in liver transplant
Description
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.
Time Frame
From date of transplant to end of year 3
Title
6-month acute kidney rejection in simultaneous liver/kidney transplant recipients
Description
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)
Time Frame
From date of transplant to 6 months post transplant
Title
1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only
Description
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)
Time Frame
From date of transplant to end of year 1
Title
Number of Non-alcoholic fatty liver (NAFL)
Description
Cumulative incidence of NAFL as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Time Frame
From date of transplant through end of follow-up, up to 3 years
Title
Number of steatohepatitis (NASH)
Description
Cumulative incidence of NASH as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Time Frame
From date of transplant through end of follow-up, up to 3 years
Title
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Description
Analysis of repeated measures of CD4 (cells/mm3) count (longitudinal model)
Time Frame
From date of transplant through end of follow up, up to 4 years
Title
Trajectory of recipient plasma HIV RNA over time
Description
Analysis of repeated measures of plasma HIV RNA (copies/mL) longitudinal model
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Graft function as assessed by Fibrosis-4 index
Description
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.
Time Frame
1 years post-transplant
Title
Graft function as assessed by Fibrosis-4 index
Description
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.
Time Frame
2 years post-transplant
Title
Graft function as assessed by Fibrosis-4 index
Description
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.
Time Frame
3 years post-transplant
Title
Graft function as assessed by Fibrosis-4 index
Description
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.
Time Frame
4 years post-transplant
Title
Graft function as assessed by incidence of fibrosis
Description
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).
Time Frame
From date of transplant through end of follow-up, up to 3 years
Title
Graft function as assessed by liver stiffness
Description
Mean calculated liver stiffness by transient elastography (kPA)
Time Frame
1 year post-transplant
Title
Graft function as assessed by liver stiffness
Description
Mean calculated liver stiffness by transient elastography (kPA)
Time Frame
2 years post-transplant
Title
Graft function as assessed by liver stiffness
Description
Mean calculated liver stiffness by transient elastography (kPA)
Time Frame
3 years post-transplant
Title
Average graft function as assessed by aspartate aminotransferase (AST)
Description
Mean calculated AST (U/L)
Time Frame
1 year post-transplant
Title
Average graft function as assessed by AST
Description
Mean calculated AST (U/L)
Time Frame
2 years post-transplant
Title
Average graft function as assessed by AST
Description
Mean calculated AST (U/L)
Time Frame
3 years post-transplant
Title
Average graft function as assessed by AST
Description
Mean calculated AST (U/L)
Time Frame
4 years post-transplant
Title
Average graft function as assessed by alanine aminotransferase (ALT)
Description
Mean calculated ALT (U/L)
Time Frame
1 year post-transplant
Title
Average graft function as assessed by ALT
Description
Mean calculated ALT (U/L)
Time Frame
2 years post-transplant
Title
Average Graft function as assessed by ALT
Description
Mean calculated ALT (U/L)
Time Frame
3 years post-transplant
Title
Average graft function as assessed by ALT
Description
Mean calculated ALT (U/L)
Time Frame
4 years post-transplant
Title
Average graft function as assessed by bilirubin
Description
Mean calculated bilirubin (mg/dL)
Time Frame
1 year post-transplant
Title
Average graft function as assessed by bilirubin
Description
Mean calculated bilirubin (mg/dL)
Time Frame
2 years post-transplant
Title
Average graft function as assessed by bilirubin
Description
Mean calculated bilirubin (mg/dL)
Time Frame
3 years post-transplant
Title
Average graft function as assessed by Bilirubin
Description
Mean calculated bilirubin (mg/dL)
Time Frame
4 years post-transplant
Title
Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score
Description
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
Time Frame
1 year post-transplant
Title
Graft function as assessed by Mean calculated MELD score
Description
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
Time Frame
2 years post-transplant
Title
Graft function as assessed by Mean calculated MELD score
Description
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
Time Frame
3 years post-transplant
Title
Graft function as assessed by Mean calculated MELD score
Description
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
Time Frame
4 years post-transplant
Title
Graft function as assessed by AST to Platelet Ratio (APRI) index
Description
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.
Time Frame
1 year post-transplant
Title
Graft function as assessed by AST to Platelet Ratio (APRI) index
Description
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.
Time Frame
2 years post-transplant
Title
Graft function as assessed by AST to Platelet Ratio (APRI) index
Description
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.
Time Frame
3 years post-transplant
Title
Graft function as assessed by AST to Platelet Ratio (APRI) index
Description
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.
Time Frame
4 years post-transplant
Title
Metabolic Outcome as assessed by Body mass index (BMI)
Description
Mean calculated BMI (weight in kilograms/height in meters squared)
Time Frame
1 year post-transplant
Title
Metabolic Outcome as assessed by Body mass index (BMI)
Description
Mean calculated BMI(weight in kilograms/height in meters squared)
Time Frame
2 years post-transplant
Title
Metabolic Outcome as assessed by Body mass index (BMI)
Description
Mean calculated BMI(weight in kilograms/height in meters squared)
Time Frame
3 years post-transplant
Title
Metabolic Outcome as assessed by Body mass index (BMI)
Description
Mean calculated BMI(weight in kilograms/height in meters squared)
Time Frame
4 years post-transplant
Title
Average hemoglobin a1c among participants at 1 year
Description
Mean calculated hemoglobin a1c (mg/dL)
Time Frame
1 years post-transplant
Title
Average hemoglobin a1c among participants at 2 years
Description
Mean calculated hemoglobin a1c (mg/dL)
Time Frame
2 years post-transplant
Title
Average hemoglobin a1c among participants at 3 years
Description
Mean calculated hemoglobin a1c (mg/dL)
Time Frame
3 years post-transplant
Title
Average hemoglobin a1c among participants at 4 years
Description
Mean calculated hemoglobin a1c (mg/dL)
Time Frame
4 years post-transplant
Title
Number of HIV breakthroughs
Description
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
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Number of opportunistic infections
Description
Cumulative incidence of opportunistic infections
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Number of X4 tropic virus breakthroughs
Description
Measured by sending virus at time of breakthrough for HIV co-receptor assay
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Number of vascular complications
Description
Number of vascular complications within 1 year of transplant, e.g. thrombosis, aneurysm
Time Frame
From date of transplant through year 1
Title
Number of surgical complications
Description
Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Time Frame
From date of transplant through year 1
Title
Number of viral-related malignancies
Description
Number of malignancies as determined by local pathology
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Hepatitis C (HCV) sustained viral response post-transplant
Description
Proportion of HCV RNA positive recipients that achieve a sustained virologic response week 12 post-treatment (<15 IU/mL) with direct acting antivirals
Time Frame
12 weeks HCV treatment
Title
Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies
Description
Proportion of participants with a de novo donor-specific HLA antibody as measured and reported by local sites' lab
Time Frame
From date of transplant through end of year 1
Title
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
Description
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
Time Frame
From date of transplant through end of follow-up, up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Durand, MD
Phone
410-955-5684
Email
cdurand2@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dorry Segev, MD, PhD
Phone
410-502-6115
Email
dorry.segev@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Durand, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babak Orandi, MD
Email
borandi@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Katherine Miller, RN, CCRP
Email
katherinemiller@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Babak Orandi, MD
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanouil Giorgakis, MD
Email
egiorgakis@uams.edu
First Name & Middle Initial & Last Name & Degree
Pamela Buckner, BSN, RN, CPN
Phone
501-603-1074
Email
pbuckner@uams.edu
First Name & Middle Initial & Last Name & Degree
Emmanouil Giorgakis, MD
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Aslam, MD
Email
saslam@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Phirum Nguyen, BS
Phone
858-822-3108
Email
psnguyen@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Saima Aslam, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94193
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Price, MD
Email
jennifer.price@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Yanin Srisengfa
Email
tab.srisengfa@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Price, MD
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maricar Malinis, MD
Phone
203-785-3561
Email
maricar.malinis@yale.edu
First Name & Middle Initial & Last Name & Degree
Ricarda Tomlin, BS, CCRP
Phone
203-785-2073
Email
ricarda.tomlin@yale.edu
First Name & Middle Initial & Last Name & Degree
Maricar Malinis, MD
Facility Name
MedStar Georgetown Transplant Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coleman Smith, MD
Email
coleman.i.smith@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Rochell Yacat
Email
Rochell.Yacat@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Coleman Smith, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacque Simkins-Cohen, MD
Email
jsimkins@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jacque Simkins-Cohen, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William H. Kitchens Jr., MD, PhD
Phone
404-727-8196
Email
william.henry.kitchens.jr@emory.edu
First Name & Middle Initial & Last Name & Degree
Jeryl Huckaby, MSCRA, CCRC
Email
jhuckab@emory.edu
First Name & Middle Initial & Last Name & Degree
William H. Kitchens Jr., MD, PhD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Stosor, MD
Phone
312-695-5085
Email
v-stosor@morthwestern.edu
First Name & Middle Initial & Last Name & Degree
Leah Goudy, RN
Email
leah.goudy@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Valentina Stosor, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos A Santos, MD
Email
Carlos_A_Santos@rush.edu
First Name & Middle Initial & Last Name & Degree
Mark Mall
Email
Mark_Mall@rush.edu
First Name & Middle Initial & Last Name & Degree
Carlos A Santos, MD
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Spaggiari, MD
Phone
312-675-9570
Email
mspaggia@uic.edu
First Name & Middle Initial & Last Name & Degree
Kelly Bruno
Email
kbruno@uic.edu
First Name & Middle Initial & Last Name & Degree
Mario Spaggiari, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandrashekhar Kubal, MD, PhD
Email
sakubal@iupui.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Lehman
Email
jgeck@iu.edu
First Name & Middle Initial & Last Name & Degree
Chandrashekhar Kubal, MD, PhD
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Hand, MD
Email
jonathan.hand@ochsner.org
First Name & Middle Initial & Last Name & Degree
Angela R. Smith
Phone
504-703-2061
Email
anglsmith@ochsner.org
First Name & Middle Initial & Last Name & Degree
Jonathan Hand, MD
Facility Name
University of Maryland, Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Husson, MD, MPH
Phone
410-706-8614
Email
jhusson@ihv.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Ka Wing Joyce Lam
Email
jlam@ihv.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Husson, MD, MPH
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Durand, MD
Phone
410-955-5684
Email
cdurand2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Magaly Rodriguez, RN
Email
mrodri57@jhu.edu
First Name & Middle Initial & Last Name & Degree
Christine Durand, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahel Elias, MD
Phone
617-726-0174
Email
elias.nahel@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Margaret Thomas Mutty, BS
Phone
617-643-6266
Email
mvthomas@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Nahel Elias, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Pruett, MD
Email
tlpruett@umn.edu
First Name & Middle Initial & Last Name & Degree
Michelle Landweer
Email
mland@umn.edu
First Name & Middle Initial & Last Name & Degree
Timothy Pruett, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Florman, MD
Phone
212-659-8313
Email
sander.florman@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Brandy Haydel
Phone
212-241-0255
Email
brandy.haydel@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Sander Florman, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Pereira, MD, MPH
Phone
212-305-3839
Email
mp2323@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Dominique Piquant
Email
dp2997@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Marcus Pereira, MD, MPH
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Small, MD
Email
cbs9003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Salsgiver
Email
els7021@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Catherine Small, MD
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
11016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sapna Mehta, MD
Phone
646-754-1006
Email
sapna.mehta@nyumc.org
First Name & Middle Initial & Last Name & Degree
Rebecca Dieter, PharmD
Email
rebecca.dieter@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Sapna Mehta, MD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senu Apewokin, MD
Phone
513-558-4253
Email
apewoksu@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Samantha Kramer
Email
kramers5@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Senu Apewokin, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Blumberg, MD
Phone
215-662-7066
Email
blumbere@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Maryann Najdzinowicz, RN
Email
maryann.najdzinowicz@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Emily Blumberg, MD
Facility Name
UPMC - University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghady Haidar, MD
Phone
412-648-6212
Email
haidarg@upmc.edu
First Name & Middle Initial & Last Name & Degree
Kailey Hughes
Phone
412-648-6453
Email
hugheskl4@upmc.edu
First Name & Middle Initial & Last Name & Degree
Ghady Haidar, MD
Facility Name
University of Tennessee Health and Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasanthi Balarman, MD
Email
vbalara1@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Quentin Youngman
Email
qthacker@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Vasanthi Balarman, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wojciechowski, DO
Email
David.Wojciechowski@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Witney Baah
Email
witney.baah@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
David Wojciechowski, DO

12. IPD Sharing Statement

Citations:
PubMed Identifier
34453519
Citation
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.
Results Reference
derived

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

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