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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
  Purpose

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.


Condition
HIV Infections
Kidney Disease
Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Solid Organ Transplantation in HIV: Multi-Site Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Subject survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • graft survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 275
Study Start Date: October 2003
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-positive patients who undergo kidney or liver transplantation.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074386

Locations
United States, California
Cedar-Sinai Hospital
Los Angeles, California, United States, 90035
University of California, San Francisco
San Francisco, California, United States, 94105
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Washington Hospital Center
Washington, District of Columbia, United States, 20010-2975
United States, Florida
University of Miami, Jackson Memorial Medical Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
Columbia Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
The University Hospital, Cincinnati
Cincinnati, Ohio, United States, 45219-2316
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh, Thomas E. Starzl Institute
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908-0265
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Peter Stock, MD University of California, San Francisco
Principal Investigator: Michelle Roland University of California, San Francisco
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00074386     History of Changes
Obsolete Identifiers: NCT00023478, NCT00473629
Other Study ID Numbers: 1U01AI052748, 1U01AI052748
Study First Received: December 11, 2003
Last Updated: January 16, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
HIV
Transplant
Liver
Kidney
Organ
Treatment Experienced
Kidney Transplant
Liver Transplant

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Kidney Diseases
Liver Diseases
Digestive System Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Urologic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014