NCT03170414

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• HIV
• Awaiting Organ Transplant

Timeline

• Start date: 2017-06-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-05-31
• Last updated: 2024-02-12

Locations

1 site across 1 country: United States