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Kidney and Liver Transplantation in People With HIV
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), January 2008
First Received: December 11, 2003   Last Updated: February 16, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00074386
  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: Cohort, Prospective
Official Title: Solid Organ Transplantation in HIV: Multi-Site Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Biospecimen Description:

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


Estimated Enrollment: 275
Study Start Date: October 2003
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: February 2009 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074386

Contacts
Contact: Rodney Rogers 415-514-2194 rogersr@surgery.ucsf.edu
Contact: Helena Diopp (301) 402-7257 dioph@niaid.nih.gov

Locations
United States, California
Cedar-Sinai Hospital Recruiting
Los Angeles, California, United States, 90035
Contact: Sandy Leong     310-423-5453     leongs@cshs.org    
Principal Investigator: Fred Poordad, MD            
Principal Investigator: Nicholas Nissen, MD            
University of California, San Francisco Recruiting
San Francisco, California, United States, 94105
Contact: Laurie Carlson     415-353-8892     CarlsonL@surgery.ucsf.edu    
Contact: Annette Klemme     415-353-8592     klemmeA@surgery.ucsf.edu    
Principal Investigator: Peter Stock, MD            
Principal Investigator: Michelle Roland, MD            
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Dana Maglaris     202-444-1769     dxm01@gunet.georgetown.edu    
Principal Investigator: Lynt Johnson, MD            
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010-2975
Contact: Peggy Cummings     202-877-8946     Peggy.W.Cummings@medstar.net    
Principal Investigator: Jimmy Light, MD            
United States, Florida
University of Miami, Jackson Memorial Medical Center Recruiting
Miami, Florida, United States, 33136
Contact: Lois Hanson (kidney)     305-355-5048     LHanson2@med.miami.edu    
Contact: Debbie Wepler (liver)     305-585-6092     DWeppler@med.miami.edu    
Principal Investigator: Jorge Diego, MD            
Principal Investigator: Dave Roth, MD            
Principal Investigator: Andreas Tzakis            
Principal Investigator: Arie Regev            
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Beth Begley     404-712-7168     beth_begley@emoryhealthcare.org    
Principal Investigator: Tom Pearson, MD            
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Sara Rosenkoetter     773-834-9796     srosenko@medicine.bsd.uchicago.edu    
Principal Investigator: Robert Harland, MD            
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Rick T. Reyes, RN         Richard_Reyes@rush.edu    
Contact: Kristine Richards, RN     312-942-9156     kristine_l_richards@rush.edu    
Principal Investigator: David Simon, MD            
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Sarah P. Hively-Johnson     312-503-2607     sphively@northwestern.edu    
Principal Investigator: Tina Stosor, MD            
Principal Investigator: Richard M Green, MD            
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Brandy Haydel     504-988-8260     brandy.haydel@hcahealthcare.com    
Contact: Susan Staulcup     504-988-3312     Susan.Staulcup@HCAhealthcare.com    
Principal Investigator: Sander Florman, MD            
Principal Investigator: Douglas Slakey, MD            
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jane Hannon, RN, BSN, MPH     410-706-8927     jhannonihvrn@gmail.com    
Principal Investigator: Robert Redfield, MD            
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Cynthia Cohen, CRNP     410-502-3895     ccohen@jhmi.edu    
Principal Investigator: Aruna Subramanian            
United States, Massachusetts
Beth Israel Deaconess Recruiting
Boston, Massachusetts, United States, 02215
Contact: Louise Riemer, RN     617-632-9813     lriemer@bidmc.harvard.edu    
Principal Investigator: Douglas Hanto, MD, PhD            
Principal Investigator: Michael Wong, MD            
United States, New York
Columbia Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Jane Cho     212-305-3839     jc2050@columbia.edu    
Principal Investigator: Lorna Dove, MD            
Principal Investigator: Jean Emond, MD            
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Inci Bijan     212-659-8049     inci.bijan@mountsinai.org    
Principal Investigator: Barbara Murphy, MD            
United States, Ohio
The University Hospital, Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219-2316
Contact: Mike Alonzo     513-475-8550     mike.alonzo@uc.edu    
Principal Investigator: Kenneth Sherman, MD            
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amy Daneri     216-445-2116     daneria@ccf.org    
Principal Investigator: John Fung, MD            
United States, Pennsylvania
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Cynthia Gifford-Hollingsworth, MSN, CPNP     215-762-8189     cgiffor1@drexelmed.edu    
Principal Investigator: Anil Kumar, MD            
Principal Investigator: Burkhardt Ringe, MD            
Principal Investigator: Jeffrey Jacobson, MD            
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maryann Najdzinowicz     215-662-4007     maryann.najdzinowicz@uphs.upenn.edu    
Principal Investigator: Kim Olthoff, MD            
Principal Investigator: Emily Blumberg, MD            
University of Pittsburgh, Thomas E. Starzl Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Laurie Hope, RN     412-692-2208     hopelk@upmc.edu    
Principal Investigator: Maggie Ragni, MD            
Principal Investigator: Ronald Shapiro            
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908-0265
Contact: Courtney Garbee, MS     434-243-6156     CFG2P@virginia.edu    
Principal Investigator: Timothy Pruett, MD            
Sponsors and Collaborators
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:
Carter JT, Melcher ML, Carlson LL, Roland ME, Stock PG. Thymoglobulin-associated Cd4+ T-cell depletion and infection risk in HIV-infected renal transplant recipients. Am J Transplant. 2006 Apr;6(4):753-60.
Frassetto L, Baluom M, Jacobsen W, Christians U, Roland ME, Stock PG, Carlson L, Benet LZ. Cyclosporine pharmacokinetics and dosing modifications in human immunodeficiency virus-infected liver and kidney transplant recipients. Transplantation. 2005 Jul 15;80(1):13-7.
Roland ME, Carlson LL, Frassetto LA, Stock PG. Solid organ transplantation: referral, management, and outcomes in HIV-infected patients. AIDS Read. 2006 Dec;16(12):664-8, 675-8. Review.
Roland ME, Stock PG. Liver transplantation in HIV-infected recipients. Semin Liver Dis. 2006 Aug;26(3):273-84. Review.
Roland ME, Stock PG. Solid organ transplantation is a reality for patients with HIV infection. Curr HIV/AIDS Rep. 2006 Sep;3(3):132-8. Review.
Terrault NA, Carter JT, Carlson L, Roland ME, Stock PG. Outcome of patients with hepatitis B virus and human immunodeficiency virus infections referred for liver transplantation. Liver Transpl. 2006 May;12(5):801-7.
Bihl FK, Loggi E, Chisholm JV 3rd, Hewitt HS, Henry LM, Linde C, Suscovich TJ, Wong JT, Frahm N, Andreone P, Brander C. Simultaneous assessment of cytotoxic T lymphocyte responses against multiple viral infections by combined usage of optimal epitope matrices, anti- CD3 mAb T-cell expansion and "RecycleSpot" J Transl Med. 2005 May 11;3(1):20.
Frassetto LA, Browne M, Cheng A, Wolfe AR, Roland ME, Stock PG, Carlson L, Benet LZ. Immunosuppressant pharmacokinetics and dosing modifications in HIV-1 infected liver and kidney transplant recipients. Am J Transplant. 2007 Dec;7(12):2816-20. Epub 2007 Oct 19.
Stock PG, Roland ME. Evolving clinical strategies for transplantation in the HIV-positive recipient. Transplantation. 2007 Sep 15;84(5):563-71.

Responsible Party: University of California, San Francisco ( Peter Stock, MD, PhD/ Professor in Residence )
Study ID Numbers: 1U01AI052748
Study First Received: December 11, 2003
Last Updated: February 16, 2009
ClinicalTrials.gov Identifier: NCT00074386     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
Transplant
Liver
Kidney
Organ
Treatment Experienced
Kidney Transplant
Liver Transplant

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

ClinicalTrials.gov processed this record on February 08, 2010