Status:
COMPLETED
Kidney and Liver Transplantation in People With HIV
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Kidney Disease
Eligibility:
All Genders
1+ years
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 ...
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 candidat...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- HIV infection
- Undetectable HIV viral load
- Meet all eligibility requirements for a transplant (same requirements that HIV uninfected patients must meet)
- Willing to take medication to prevent certain infections
- Willing to undergo frequent monitoring, including liver biopsies, and treatment, if participant has hepatitis B or C virus infection
- Willing to submit laboratory test results within 7 days of blood draw
- Willing to notify the transplant team before changing any medications
- If participant has a history of HIV-related cancers or opportunistic infections, some additional eligibility criteria must be met.
- Inclusion Criteria for Patients Undergoing Kidney Transplant:
- CD4 count greater than 200 cells/mm3. CD4 count requirement for children will be based on child's age. Participant cannot have used the drugs IL-2 or GM-CSF in order to increase the CD4 count in the 6 months prior to transplant.
- Inclusion Criteria for Patients Undergoing Liver Transplant:
- CD4 count greater than 100 cells/mm3. CD4 count requirement for children will be based on child's age. Some participants with certain HIV-related diseases must have a CD4 count that is greater than 200 cells/ml for the 6 months prior to study entry.
- Exclusion Criteria for All Participants:
- Pregnancy
- Significant wasting or weight loss
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00074386
Start Date
October 1 2003
End Date
August 1 2013
Last Update
January 17 2014
Active Locations (21)
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1
Cedar-Sinai Hospital
Los Angeles, California, United States, 90035
2
University of California, San Francisco
San Francisco, California, United States, 94105
3
Georgetown University
Washington D.C., District of Columbia, United States, 20007
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010-2975