Kidney and Liver Transplantation in People With HIV

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00074386
First received: December 11, 2003
Last updated: January 16, 2014
Last verified: January 2014

December 11, 2003
January 16, 2014
October 2003
August 2013   (final data collection date for primary outcome measure)
  • Subject survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • graft survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Subject survival
  • graft survival
Complete list of historical versions of study NCT00074386 on ClinicalTrials.gov Archive Site
  • Opportunistic complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • CD4+ T cell counts and HIV-1 RNA levels [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • rejection rates and markers of alloresponse [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • pharmacokinetic interactions between immunosuppressive agents and antiretrovirals [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Opportunistic complications
  • CD4+ T cell counts and HIV-1 RNA levels
  • viral markers and host-response (CFC and ELISPOT) to viral co-pathogens, including HBV, HCV,CMV, EBV, HHV-6, HHV-8, and HPV
  • rejection rates and markers of alloresponse
  • pharmacokinetic interactions between immunosuppressive agents and antiretrovirals
Not Provided
Not Provided
 
Kidney and Liver Transplantation in People With HIV
Solid Organ Transplantation in HIV: Multi-Site Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole Blood, serum, PBMC, kidney and liver biopsy slides, saliva, spleen tissue

Probability Sample

HIV-positive patients who undergo kidney or liver transplantation.

  • HIV Infections
  • Kidney Disease
  • Liver Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074386
1U01AI052748, 1U01AI052748
Yes
University of California, San Francisco
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Peter Stock, MD University of California, San Francisco
Principal Investigator: Michelle Roland University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP