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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02602262
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
University of Colorado, Denver
Yale University
Georgetown University
Emory University
Rush University Medical Center
University of Illinois at Chicago
Indiana University Health
University of Maryland
Columbia University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
University of Pittsburgh
Methodist Health System
Northwestern Memorial Hospital
New York University School of Medicine
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment
HIV Infection Other: HIV-infected deceased donor organ

Detailed Description:

This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.

In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.


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Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients
Study Start Date : November 2015
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV D+/R+
HIV-infected individuals who accept an organ from an HIV-infected deceased donor
Other: HIV-infected deceased donor organ
HIV-infected deceased donor organ transplant

HIV D-/R+
HIV-infected individuals who accept an organ from an HIV-uninfected deceased donor



Primary Outcome Measures :
  1. Survival [ Time Frame: One year ]
    Patient survival at one year


Secondary Outcome Measures :
  1. Graft survival [ Time Frame: one year, two years, 3 years, 4 years ]
    Transplanted organ function

  2. Graft rejection [ Time Frame: One year ]
    Incidence and severity of organ rejection

  3. HIV disease progression [ Time Frame: through study completion, up to 4 years ]
    Incidence of virologic breakthrough or failure

  4. Antiretroviral resistance and X4 tropic virus [ Time Frame: through study completion, up to 4 years ]
    incidence of new antiretroviral drug resistance and/or X4 tropic virus

  5. Incidence of bacterial, fungal, viral, and other opportunistic infection [ Time Frame: through study completion, up to 4 years ]
    incidence of bacterial, fungal, viral, and other opportunistic infections

  6. Surgical complications [ Time Frame: within the first 3 months ]
    incidence of surgical and vascular transplant complications

  7. Recurrent HIV-associated nephropathy [ Time Frame: through study completion, up to 4 years ]
    incidence of recurrent HIV-associated nephropathy in kidney recipients

  8. Incidence of post-transplant Malignancy [ Time Frame: through study completion, up to 4 years ]
    incidence of post-transplant malignancies

  9. Incidence of HIV superinfection in blood and/or tissue [ Time Frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4 ]
    Incidence of HIV superinfection in blood and/or tissue

  10. HIV latent reservoir [ Time Frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4 ]
    Frequency of infected CD4 T cells in blood

  11. Immune activation [ Time Frame: measured at 3 months, 6 months, year 1, year 2, year 3, year 4 ]
    Cytokine levels


Biospecimen Retention:   Samples With DNA
Plasma, serum, peripheral blood mononuclear cells, tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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.

  1. Participant is able to understand and provide informed consent
  2. Participant meets standard listing criteria for transplant.
  3. 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).
  4. Participant is > 18 years old.
  5. 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.
  6. Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.
  7. 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.
  8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.

Exclusion Criteria:

  1. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
  2. Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.
  3. 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.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602262


Contacts
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Contact: Christine Durand, MD 410-955-5684 cdurand2@jhmi.edu
Contact: Dorry Segev, MD, PhD 410-502-6115 dorry@jhmi.edu

Locations
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United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Maheen Abidi, MD    303-724-4930    maheen.abidi@ucdenver.edu   
Principal Investigator: Maheen Abidi, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Maricar Malinis, MD    203-785-2073    maricar.malinis@yale.edu   
Contact: Ricarda Tomlin    203-785-2073    ricarda.tomlin@yale.edu   
Principal Investigator: Maricar Malinis, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Alexander Gilbert, MD    202-444-3700    alexander.j.gilbert@gunet.georgetown.edu   
Principal Investigator: Alexander Gilbert, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nicole Turgeon, MD    404-727-3257    nturgeo@emory.edu   
Principal Investigator: Nicole Turgeon, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Valentina Stosor, MD    312-695-5085    v-stosor@northwestern.edu   
Principal Investigator: Valentina Stosor, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Carlos Santos, MD, MPHS    312-942-5864    carlos_a_santos@rush.edu   
Contact: Mark Mall, RN    312-942-5865    mark_mall@rush.edu   
Principal Investigator: Carlos Santos, MD, MPHS         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Mario Spaggiari, MD    312-675-9570    mspaggia@uic.edu   
Contact: Patricia West-Thielke, PharmD    312-533-1390    pwest@uic.edu   
Principal Investigator: Mario Spaggiari, MD         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Oluwafisayo Adebiyi, MD    317-944-4370    olabiy@iu.edu   
Principal Investigator: Oluwafisayo Adebiyi, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Anthony Amoroso, MD    410-706-4607    aamoroso@ihv.umaryland.edu   
Contact: Jennifer Husson, MD, MPH    410-706-8614    jhusson@ihv.umaryland.edu   
Principal Investigator: Anthony Amoroso, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Christine Durand, MD    410-955-5684    cdurand2@jhmi.edu   
Contact: Diane Brown, RN, MSN    410-614-0648    dbrown22@jhmi.edu   
Principal Investigator: Christine Durand, MD         
Principal Investigator: Dorry Segev, MD, PhD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Sapna Mehta, MD    646-754-1006    sapna.mehta@nyumc.org   
Principal Investigator: Sapna Mehta, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Sander Florman, MD    212-659-8313    sander.florman@mountsinai.org   
Contact: Shirish Huprikar, MD       shirish.huprikar@mountsinai.org   
Principal Investigator: Sander Florman, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Cristina Falo, PhD    212-305-3839    cf2427@cumc.columbia.edu   
Principal Investigator: Marcus Pereira, MD, MPH         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Thangamani Muthukumar, MD    212-746-4430    mut9002@med.cornell.edu   
Contact: Catherine Small, MD    914-552-5960    cbs9003@med.cornell.edu   
Principal Investigator: Thangamani Muthukumar, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ghady Haidar, MD    412-648-6212    haidarg@upmc.edu   
Contact: Fernanda Silveira, MD    412-648-6512    silvfd@upmc.edu   
Principal Investigator: Ghady Haidar, MD         
United States, Texas
Methodist Health System Recruiting
Dallas, Texas, United States, 75203
Contact: Jose A. Castillo-Lugo, MD    214-358-2300    castilloj@dneph.com   
Principal Investigator: Jose A. Castillo-Lugo, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Avinash Agarwal, MD    434-924-9370    AA4VB@hscmail.mcc.virginia.edu   
Principal Investigator: Avinash Agarwal, MD         
Sponsors and Collaborators
Johns Hopkins University
University of Colorado, Denver
Yale University
Georgetown University
Emory University
Rush University Medical Center
University of Illinois at Chicago
Indiana University Health
University of Maryland
Columbia University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
University of Pittsburgh
Methodist Health System
Northwestern Memorial Hospital
New York University School of Medicine
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Christine Durand, MD Johns Hopkins University
Principal Investigator: Dorry Segev, MD, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02602262     History of Changes
Other Study ID Numbers: IRB00085148
JHUHIVDD ( Other Identifier: Site Specific Identifier )
1U01AI134591-01 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases