Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
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:
๐Ÿฆ  HIV Infection
๐Ÿ—“๏ธ Study Start (Actual) November 2015
๐Ÿ—“๏ธ Primary Completion (Estimated) July 2025
โœ… Study Completion (Estimated) 1 July 2026
๐Ÿ‘ฅ Enrollment (Estimated) 125
๐Ÿ”ฌ Study Type OBSERVATIONAL
๐Ÿ“Š Phase N/A
Locations:
๐Ÿ“ Aurora, Colorado, United States
๐Ÿ“ New Haven, Connecticut, United States
๐Ÿ“ Washington, District of Columbia, United States
๐Ÿ“ Atlanta, Georgia, United States
๐Ÿ“ Chicago, Illinois, United States
๐Ÿ“ Chicago, Illinois, United States
๐Ÿ“ Chicago, Illinois, United States
๐Ÿ“ Indianapolis, Indiana, United States
๐Ÿ“ Baltimore, Maryland, United States
๐Ÿ“ Baltimore, Maryland, United States
๐Ÿ“ Saint Louis, Missouri, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ Pittsburgh, Pennsylvania, United States
๐Ÿ“ Dallas, Texas, United States
๐Ÿ“ Charlottesville, Virginia, United States

๐Ÿ“‹ Eligibility Criteria

Description

    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/ยตL 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 November 2015
  • First Submitted that Met QC Criteria 9 November 2015
  • First Posted 11 November 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 December 2023
  • Last Update Posted 15 December 2023
  • Last Verified December 2023