Kidney and Liver Transplantation in People With HIV

Completed

• Conditions: HIV Infections; Kidney Disease; Liver Disease

• Registration Number: NCT00074386
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-12-11
• Study First Submitted QC: 2003-12-12
• Study First Posted: 2003-12-15
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
graft survival	5 years
Subject survival	5 years

Secondary Outcome Measures

Name	Time	Method
viral markers and host-response (CFC and ELISPOT) to viral co-pathogens, including HBV, HCV,CMV, EBV, HHV-6, HHV-8, and HPV	5 years
rejection rates and markers of alloresponse	5 years
pharmacokinetic interactions between immunosuppressive agents and antiretrovirals	5 years
CD4+ T cell counts and HIV-1 RNA levels	5 years
Opportunistic complications	5 years

Trial Locations

Locations (21)

Cedar-Sinai Hospital; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Miami, Jackson Memorial Medical Center; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

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