Kidney and Liver Transplantation in People With HIV
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|ClinicalTrials.gov Identifier: NCT00074386|
Recruitment Status : Completed
First Posted : December 15, 2003
Last Update Posted : January 17, 2014
|Condition or disease|
|HIV Infections Kidney Disease Liver Disease|
HIV infected people are at significant risk for end stage organ disease. Prior to the advent of highly active antiretroviral therapy (HAART), these people were often not considered transplant candidates based on concern about potential adverse effects of immunosuppressive drugs on HIV disease progression. However, with the use of HAART, HIV infected people have experienced significant improvements in morbidity and mortality. HIV infected people with end stage kidney and liver disease are now potential candidates for transplantation, yet patients and clinicians lack the necessary data to determine the safety and efficacy of transplantation and immunosuppression in this group. This lack of conclusive data has led to continued denial of care by many transplant centers and third party payers, resulting in frustration and confusion for both patients and their health care providers.
This study will evaluate the safety and efficacy of solid organ transplantation in people with HIV infection by following a prospective, multi-center cohort of HIV infected people who undergo kidney or liver transplantation. The long-term goals are: 1) to provide patients and clinicians with information regarding the HIV-specific risks of transplantation; 2) to provide clinicians with information necessary to manage immunosuppressive and HAART medications together; and 3) to understand underlying basic science mechanisms that explain patient outcomes so that clinical management can be adjusted to improve outcomes.
Approximately 150 kidney and 125 liver transplant patients will be enrolled in this study over a 3-year period at medical research centers throughout the United States. Participants will be enrolled in the study for five years from the day of the transplant.
|Study Type :||Observational|
|Actual Enrollment :||275 participants|
|Official Title:||Solid Organ Transplantation in HIV: Multi-Site Study|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
- Subject survival [ Time Frame: 5 years ]
- graft survival [ Time Frame: 5 years ]
- Opportunistic complications [ Time Frame: 5 years ]
- CD4+ T cell counts and HIV-1 RNA levels [ Time Frame: 5 years ]
- viral markers and host-response (CFC and ELISPOT) to viral co-pathogens, including HBV, HCV,CMV, EBV, HHV-6, HHV-8, and HPV [ Time Frame: 5 years ]
- rejection rates and markers of alloresponse [ Time Frame: 5 years ]
- pharmacokinetic interactions between immunosuppressive agents and antiretrovirals [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
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): NCT00074386
|Principal Investigator:||Peter Stock, MD||University of California, San Francisco|
|Principal Investigator:||Michelle Roland||University of California, San Francisco|