Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTulane University
About this trial
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol.
The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant meets standard listing criteria for transplant.
Greater than or equal to 18 years of age.
Participant has documented HIV infection using an FDA-licensed, approved, or cleared test device(s).
CD4+ T-cell count ≥200/μL within 16 weeks prior to transplant; any patient with history of Opportunistic Infections must have a CD4 positive T-cell count ≥200/uL.
Disqualifiers
Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
Less than 18 years of age.
Requires multi-organ transplantation.
Participant is pregnant or breastfeeding.
Trial population
Participants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Kidney transplant
Procedure/SurgeryParticipants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Kidney transplant recipients1 intervention
Group B: Kidney living donors1 intervention
Trial outcomes
Primary outcomes
1
Patient mortality rate after kidney transplant
Patient will be followed after kidney transplant and the mortality rate will be measured by patient survival post op.
Time frame
1 YearSecondary outcomes
1
Graft survival in transplant recipients
The graft survival will be measured in transplant recipients by: 1. Proportion of participants with Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \< 60 mL/min/1.73 m2 . 2. Proportion of participants with defined Chronic Kidney Disease (CKD) stage 4 or 5. 3. Mean calculated eGFR by CKD-EPI.
Time frame
3, 6, 9, 12, 24, 36, 48, 60 Months2
Incidence and severity of graft rejection for transplant recipients
The incidence and severity of graft rejection in transplant recipients will be measured by: 1. Incidence of clinically suspected and biopsy proven acute rejection within the study period as defined as histologic evidence of rejection and graft dysfunction on biopsy. 2. The severity of first and highest grade of acute cellular rejection within the study period. 3. The incidence of antibody mediated rejection. 4. The type of treatment for rejection. (The graft biopsy or kidney transplant recipients of HIV+ donor at month 6 and year 1 and for all transplant recipients at any point the clinical team feels is indicated).
Time frame
6, 9, 12, 24, 36, 48, 60 MonthsSponsors and contacts
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Source ClinicalTrials.gov