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

NCT03500315 | Completed DMC

• 2 other identifiers: IRB00141138U01AI134591
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 29

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• 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 HIV virologic failure or opportunistic infection

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

Secondary Outcomes (35)

• Pre-transplant mortality

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

• Graft failure

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

• Rate of serious adverse events

  From date of transplant through graft failure or administrative censorship at study completion, up to year 4

• 6-month acute rejection

  From date of transplant to end of month 6

• 1-year acute rejection

  From date of transplant to end of year 1

Study Arms (3)

HIV D+/R+

EXPERIMENTAL

HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100

Other: HIV D+/R+

HIV D-/R+

NO INTERVENTION

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100

HIV D-/R+ (observational)

NO INTERVENTION

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

Interventions

HIV D+/R+ OTHER

Kidney from an HIV-infected deceased donor

HIV D+/R+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (29)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94193, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8022, United States

Location

MedStar Georgetown Transplant Institute

Washington D.C., District of Columbia, 20007, United States

Location

Miami Transplant Institute

Miami, Florida, 33136, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 212101, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC-University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Methodist Health System Clinical Research Institute

Dallas, Texas, 75203, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

• Durand CM, Massie A, Florman S, Liang T, Rana MM, Friedman-Moraco R, Gilbert A, Stock P, Mehta SA, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Aslam S, Malinis M, Haidar G, Small CB, Santos CAQ, Schaenman J, Baddley J, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Brown D, Ostrander D, Eby Y, Desai N, Naqvi F, Bagnasco S, Watson N, Brittain E, Odim J, Redd AD, Tobian AAR, Segev DL; HOPE in Action Investigators. Safety of Kidney Transplantation from Donors with HIV. N Engl J Med. 2024 Oct 17;391(15):1390-1401. doi: 10.1056/NEJMoa2403733.

  PMID: 39413376 DERIVED

• 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.

  PMID: 34453519 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 18, 2018
• Study Start: April 19, 2018
• Primary Completion: September 30, 2022
• Study Completion: May 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (29)