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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 : May 27, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Yale University
Georgetown University
Emory University
Rush University Medical Center
University of Illinois at Chicago
Indiana University
University of Maryland, College Park
Columbia University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
University of Pittsburgh Medical Center
Methodist Health System
Northwestern University
NYU Langone Health
University of Virginia
Washington University School of Medicine
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
Show Show 18 study locations
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
University of Maryland, College Park
Columbia University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
University of Pittsburgh Medical Center
Methodist Health System
Northwestern University
NYU Langone Health
University of Virginia
Washington University School of Medicine
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02602262    
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: May 27, 2020
Last Verified: May 2020

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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