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Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients | Clinical Trials | Clareo Health

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

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

NCT02602262•Johns Hopkins University

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.

Exclusion Criteria

•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.
•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.

Locations (18)

University of Colorado Denver

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Georgetown University Medical Center

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

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland, Institute of Human Virology

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

June 12, 2020

Completion Date

June 16, 2023

Last Updated

August 14, 2025

Enrollment

105

ACTUAL participants

Conditions

HIV Infection

Interventions

HIV-infected deceased donor organ

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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