Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients

Completed

• Conditions: HIV; Awaiting Organ Transplant

• Registration Number: NCT03170414
• Lead Sponsor: University of Minnesota

Brief Summary

The primary objective of this study is to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.

HIV-positive individuals who agree to accept and receive a solid organ transplant from and HIV-positive donor will be followed to determine the safety and efficacy of this practice.

Detailed Description

This is a prospective observational 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, liver) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney, liver) and living donors (liver) will be utilized in this protocol. No living kidney donors will be enrolled.

This study will evaluate overall survival and graft survival. In addition the study will assess potential complications of organ transplant using HIV+ donor organs, including but not limited to: HIV disease progression, development of antiretroviral resistance mutations, incidence of opportunistic infections, incidence of transplant complications, impacts of liver regeneration, incidence of viral-related malignancies, and incidence of HIV-superinfection.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-31
• Study Start: 2017-06-15
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Survival	One Year	Patient survival at one year.

Secondary Outcome Measures

Name	Time	Method
Incidence of other transplant complications (surgical and vascular)	Through study completion, up to three years
Incidence of bacterial, fungal, viral and other opportunistic infections	Through study completion, up to three years
HIV Disease Progression	Through study completion, up to three years
Incidence of tissue specific HIV-superinfection	Through study completion, up to three years
Liver transplant recipients: Impact on liver regeneration	Through study completion, up to three years
Incidence of systemic HIV-superinfection in blood	Through study completion, up to three years
Graft Survival	Months 3, 6, 9, Years 1, 2, 3
Incidence and Severity of Graft Rejection	Through study completion, up to three years
Development of antiretroviral resistance mutations and/or X4 tropic virus in blood and allograft	Through study completion, up to three years
Analysis of recurrent HIV associated nephropathy among kidney transplant recipients	Through study completion, up to three years
Incidence of other viral-related malignancies (HPV, EBV, HBV, HCV)	Through study completion, up to three years

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States