Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients

NCT02602262 | Completed

• 3 other identifiers: IRB00085148JHUHIVDD1U01AI134591-01
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 18

Brief Summary

HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Survival

  Patient survival at one year

  One year

Secondary Outcomes (11)

• Graft survival

  one year, two years, 3 years, 4 years

• Graft rejection

  One year

• HIV disease progression

  through study completion, up to 4 years

• Antiretroviral resistance and X4 tropic virus

  through study completion, up to 4 years

• Incidence of bacterial, fungal, viral, and other opportunistic infection

  through study completion, up to 4 years

Study Arms (2)

HIV D+/R+

HIV-infected individuals who accept an organ from an HIV-infected deceased donor

Other: HIV-infected deceased donor organ

HIV D-/R+

HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor

Interventions

HIV-infected deceased donor organ OTHER

HIV-infected deceased donor organ transplant

HIV D+/R+

Eligibility Criteria

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

Study Population

All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.

You may not qualify if:

• Participant is able to understand and provide informed consent
• Participant meets standard listing criteria for transplant.
• Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).
• Participant is \> 18 years old.
• Opportunistic Complications: None or previous history of protocol allowed opportunistic infections or neoplasms with appropriate acute and maintenance therapy and no evidence of active disease.
• Participant CD4+ T-cell count is \>/= 200/µL in the 16 weeks prior to transplant.
• Participant most recent HIV-1 RNA \< 50 copies/mL (by any FDA-approved assay performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL) should be \< 50 copies, but this result can be documented outside the 16 week window according to the judgement of the local clinical team and site investigator. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen to be used by the recipient once organ function is restored after transplantation.
• Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.
• Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
• Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of \> 1 month duration, or primary Central Nervous System (CNS) lymphoma.
• Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease free state for 2 years. History of leukemia and disease-free duration will be per site policy.
• 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 clinical practice. Women that become pregnant should not breastfeed.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Colorado, Denver: collaborator
• Yale University: collaborator
• Georgetown University: collaborator
• Emory University: collaborator
• Rush University Medical Center: collaborator
• University of Illinois at Chicago: collaborator
• Indiana University: collaborator
• University of Maryland: collaborator
• Columbia University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Pittsburgh Medical Center: collaborator
• Methodist Health System: collaborator
• Northwestern University: collaborator
• NYU Langone Health: collaborator
• University of Virginia: collaborator
• Washington University School of Medicine: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (18)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, 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

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, 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 Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Methodist Health System

Dallas, Texas, 75203, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (4)

• Arant EC, Davy-Mendez T, Liang T, Rodrigues M, Gay CL, 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 JW, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Morsheimer M, van Delden C, Manuel O, Mueller NJ, Neofyotos D, Tobian AAR, Massie A, Segev DL, Werbel W, Durand CM. Infections After Kidney Transplantation From Donors With Human Immunodeficiency Virus (HIV) to Recipients With HIV. Clin Infect Dis. 2026 Jan 12:ciaf656. doi: 10.1093/cid/ciaf656. Online ahead of print.

  PMID: 41524130 DERIVED

• Benner SE, Zhu X, Hussain S, Florman S, Eby Y, Fernandez RE, Ostrander D, Rana M, Ottmann S, Hand J, Price JC, Pereira MR, Wojciechowski D, Simkins J, Stosor V, Mehta SA, Aslam S, Malinis M, Haidar G, Massie A, Smith ML, Odim J, Morsheimer M, Quinn TC, Laird GM, Siliciano R, Balagopal A, Segev DL, Durand CM, Redd AD, Tobian AAR. HIV-Positive Liver Transplant Does not Alter the Latent Viral Reservoir in Recipients With Antiretroviral Therapy-Suppressed HIV. J Infect Dis. 2023 Nov 2;228(9):1274-1279. doi: 10.1093/infdis/jiad241.

  PMID: 37379584 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

• Bonny TS, Kirby C, Martens C, Rose R, Desai N, Seisa M, Petropoulos C, Florman S, Friedman-Moraco RJ, Turgeon NA, Brown D, Segev DL, Durand CM, Tobian AAR, Redd AD. Outcomes of donor-derived superinfection screening in HIV-positive to HIV-positive kidney and liver transplantation: a multicentre, prospective, observational study. Lancet HIV. 2020 Sep;7(9):e611-e619. doi: 10.1016/S2352-3018(20)30200-9. Epub 2020 Jul 27.

  PMID: 32730756 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, peripheral blood mononuclear cells, tissue

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; 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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: June 12, 2020
• Study Completion: June 16, 2023
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (18)