HOPE Heart HIV D+/R+ Transplant

Prospective Observational Study of Heart Transplantation from Deceased Donors with HIV to Transplant Recipients with HIV

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Heart transplantation, HIV/AIDS
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All genders
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Overview
Principal Investigator: Jennifer Chow, MD,MS

This is a prospective observational study to evaluate the safety and clinical outcomes in heart transplant recipients with HIV (R+) who receive hearts from donors with (D+) vs without HIV (D-). Adults with HIV in need of a heart transplant who meet study-specified criteria for will be offered enrollment in the study. The primary objective is to determine whether receiving a heart from a donor with (D+) vs without HIV (D-) is safe in regard to major transplant-related and HIV-related complications. Secondary Objectives: The secondary objective is to measure post-transplant outcomes of D+ and D- heart transplant (HT) in HIV+ recipients (R+).

Contact Us

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Jennifer Chow, MD, MS

Study details
Inclusion Criteria
  • Participant meets local criteria for heart transplant and is listed at Tufts MC
  • Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
  • Participant is ≥ 18 years old.
Exclusion Criteria
  • Participant has prior progressive multifocal leukoencephalopathy, cryptosporidiosis of > 1 month, or primary CNS lymphoma.
  • Participant is pregnant or breastfeeding.
  • Participents listed for simultaneous heart-kidney transplant.
Study Requirements

This is an observational study with no additional research visits of blood collections/procedures. Data collection for all participants will occur at day 0, weeks 1, 2, 4, 8, 13 (month 3), 26 (month 6), 39 (month 9), 52 (year 1), and every 6 months up to 10 years post-transplant to coincide with routine post-heart transplant care. At each study time point, data will be reviewed from the participant’s clinical evaluations and physical examinations, focusing on signs and symptoms suggestive of HIV disease progression, impaired allograft function, rejection, and opportunistic infections. CD4+ T-cell numbers and percent, and quantitative HIV-1 RNA by PCR assays will be reviewed . At each study time point, the study team member will collect and enter data into the web-based data system, including medications of interest, labs, and events of interest, such as deaths, infections, and graft loss.