Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients
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|ClinicalTrials.gov Identifier: NCT03170414|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : October 18, 2018
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.
|Condition or disease|
|HIV Awaiting Organ Transplant|
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 Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||A Prospective Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients|
|Actual Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
HIV+ recipients who receive an organ transplant from an HIV+ donor
- Patient Survival [ Time Frame: One Year ]Patient survival at one year.
- Graft Survival [ Time Frame: Months 3, 6, 9, Years 1, 2, 3 ]
- Incidence and Severity of Graft Rejection [ Time Frame: Through study completion, up to three years ]
- HIV Disease Progression [ Time Frame: Through study completion, up to three years ]
- Development of antiretroviral resistance mutations and/or X4 tropic virus in blood and allograft [ Time Frame: Through study completion, up to three years ]
- Incidence of bacterial, fungal, viral and other opportunistic infections [ Time Frame: Through study completion, up to three years ]
- Incidence of other transplant complications (surgical and vascular) [ Time Frame: Through study completion, up to three years ]
- Liver transplant recipients: Impact on liver regeneration [ Time Frame: Through study completion, up to three years ]
- Analysis of recurrent HIV associated nephropathy among kidney transplant recipients [ Time Frame: Through study completion, up to three years ]
- Incidence of other viral-related malignancies (HPV, EBV, HBV, HCV) [ Time Frame: Through study completion, up to three years ]
- Incidence of systemic HIV-superinfection in blood [ Time Frame: Through study completion, up to three years ]
- Incidence of tissue specific HIV-superinfection [ Time Frame: Through study completion, up to three years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170414
|Contact: Timothy L Pruett, MDemail@example.com|
|Contact: Varvara Kirchner, MDfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Contact: Timothy Pruett, M.D.|
|Principal Investigator:||Timothy Pruett, MD||University of Minnesota - Clinical and Translational Science Institute|