Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074386
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2003-12-11
Brief Title:
Kidney and Liver Transplantation in People With HIV
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Solid Organ Transplantation in HIV Multi-Site Study
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With improved anti-HIV drug therapy HIV infected patients are now living longer These patients are at risk for liver and kidney failure and may need organ transplants However little is know about the safety and effectiveness of organ transplants in patients with HIV This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01AI052748 | NIH | None | httpsreporternihgovquickSearch1U01AI052748 |