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HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

Primary Purpose

Hiv

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV D+/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 kidney transplant at the local center.
  • Participant is able to understand and provide informed consent.
  • Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards.
  • Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).
  • No living donor available.
  • Participant is ≥18 years old.
  • Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease.
  • Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
  • HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements >200 copies/mL.
  • Participant is willing to comply with all medication related to their transplant and HIV management.
  • For participant with a history of aspergillus colonization or disease, no evidence of active disease.
  • The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management.
  • All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control.
  • Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.

Exclusion Criteria:

  • Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.
  • Participant is pregnant or breastfeeding.
  • Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks or may impact the quality or interpretation of the data obtained from the study.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Arkansas for Medical Sciences
  • University of California, Los Angeles
  • University of California, San Diego
  • University of California, San Francisco
  • Yale University School of Medicine
  • MedStar Georgetown Transplant Institute
  • Miami Transplant Institute
  • Cleveland Clinic Florida
  • Emory University
  • Northwestern University
  • Rush University Medical Center
  • University of Illinois at Chicago
  • Indiana University
  • Ochsner Medical Center
  • Johns Hopkins University
  • University of Maryland, Institute of Human Virology
  • Massachusetts General Hospital
  • New York University School of Medicine
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • Weill Cornell Medical College
  • University of Cincinnati
  • Drexel University
  • University of Pennsylvania
  • UPMC-University of Pittsburgh Medical Center
  • Methodist Health System Clinical Research Institute
  • University of Texas Southwestern Medical Center
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

HIV D+/R+

HIV D-/R+

HIV D-/R+ (observational)

Arm Description

HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 80

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 80

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200

Outcomes

Primary Outcome Measures

Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection

Secondary Outcome Measures

Pre-transplant mortality
Time to mortality while enrolled before transplant (survival framework)
Graft failure
Time to mortality or re-transplant or return to maintenance dialysis (survival framework)
Rate of serious adverse events
Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
6-month acute rejection
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 rejection
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)
Incidence of graft rejection
Cumulative incidence of acute rejection (survival framework) 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)
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Graft function -mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function-mean eGFR
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Graft function - slope eGFR
The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis)
Incidence of non-HIV renal disease
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis
Incidence of non-HIV renal disease
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis
Incidence of HIV-related renal disease
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy
Incidence of HIV-related renal disease
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy
Donor and recipient apolipoprotein L1 (APOL1)
Proportion of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient
HIV infection of renal allografts
Proportion of recipients with HIV seen in laser capture microdissection of renal biopsy
Trajectory of recipient plasma HIV RNA over time
Analysis of repeated measures of plasma HIV RNA (longitudinal model)
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model)
Incidence of antiretroviral resistance
Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
Incidence of X4 tropic virus
Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
Incidence of opportunistic infection
Cumulative incidence of opportunistic infections
Incidence of surgical complications
Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Incidence of vascular complications
Number of vascular complications within 1 year of transplant
Incidence of viral-related malignancies
Number of malignancies as determined by local pathology
Incidence 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
Composite event, time to first
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
April 2, 2018
Last Updated
September 25, 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
NCT03500315
Brief Title
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
Official Title
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 1, 2023 (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 deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.
Detailed Description
This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.

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
Non-Randomized
Enrollment
160 (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 80
Arm Title
HIV D-/R+
Arm Type
No Intervention
Arm Description
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 80
Arm Title
HIV D-/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 - enrollment 200
Intervention Type
Other
Intervention Name(s)
HIV D+/R+
Intervention Description
Kidney from an HIV-infected deceased donor
Primary Outcome Measure Information:
Title
Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
Description
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
Time Frame
From date of transplant through administrative censorship at study completion, up to 4 years
Secondary Outcome Measure Information:
Title
Pre-transplant mortality
Description
Time 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
Description
Time 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
Rate of serious adverse events
Description
Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Time Frame
From date of transplant through graft failure or administrative censorship at study completion, up to year 4
Title
6-month acute rejection
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 month 6
Title
1-year acute rejection
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
Incidence of graft rejection
Description
Cumulative incidence of acute rejection (survival framework) 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 through administrative censorship, up to 4 years
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
3 months post-transplant
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
6 months post-transplant
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
9 months post-transplant
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
1 year post-transplant
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
2 years post-transplant
Title
Graft function - Proportion eGFR <60 mL/min/1.73 m2
Description
Proportion of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2
Time Frame
3 years post-transplant
Title
Graft function -mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
3 months post-transplant
Title
Graft function-mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
6 months post-transplant
Title
Graft function-mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
9 months post-transplant
Title
Graft function-mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
1 year post-transplant
Title
Graft function-mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
2 years post-transplant
Title
Graft function-mean eGFR
Description
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time Frame
3 years post-transplant
Title
Graft function - slope eGFR
Description
The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis)
Time Frame
From date of transplant to end of follow-up, up to 4 years
Title
Incidence of non-HIV renal disease
Description
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis
Time Frame
6 months post-transplant
Title
Incidence of non-HIV renal disease
Description
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. focal segmental glomerulosclerosis
Time Frame
1 year post-transplant
Title
Incidence of HIV-related renal disease
Description
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy
Time Frame
6 months post-transplant
Title
Incidence of HIV-related renal disease
Description
Cumulative incidence of non HIV-related renal disease as measured by biopsy, e.g. HIV-associated nephropathy
Time Frame
1 year post-transplant
Title
Donor and recipient apolipoprotein L1 (APOL1)
Description
Proportion of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient
Time Frame
Baseline
Title
HIV infection of renal allografts
Description
Proportion of recipients with HIV seen in laser capture microdissection of renal biopsy
Time Frame
6 months post-transplant
Title
Trajectory of recipient plasma HIV RNA over time
Description
Analysis of repeated measures of plasma HIV RNA (longitudinal model)
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Description
Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model)
Time Frame
From date of transplant through end of follow up, up to 4 years
Title
Incidence of antiretroviral resistance
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
Incidence of X4 tropic virus
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
Incidence of opportunistic infection
Description
Cumulative incidence of opportunistic infections
Time Frame
From date of transplant through end of follow-up, up to 4 years
Title
Incidence 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
Incidence of vascular complications
Description
Number of vascular complications within 1 year of transplant
Time Frame
From date of transplant through year 1
Title
Incidence 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
Incidence 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
Composite event, time to first
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 kidney transplant at the local center. Participant is able to understand and provide informed consent. Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards. Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA). No living donor available. Participant is ≥18 years old. Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant. HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements >200 copies/mL. Participant is willing to comply with all medication related to their transplant and HIV management. For participant with a history of aspergillus colonization or disease, no evidence of active disease. The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management. All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control. Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease. Exclusion Criteria: Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma. Participant is pregnant or breastfeeding. Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks or may impact the quality or interpretation of the data obtained from the study.
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 at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94193
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8022
Country
United States
Facility Name
MedStar Georgetown Transplant Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Miami Transplant Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Maryland, Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212101
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC-University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Methodist Health System Clinical Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

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 Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

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