Kidney and Liver Transplantation in People With HIV

Condition(s) targeted: HIV Infections; Kidney Disease; Liver Disease

Status: Recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Peter Stock, MD, Principal Investigator, Affiliation: University of California, San Francisco
Michelle Roland, Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Allison Priore, Phone: (301) 451-3151, Email: AGirouard@niaid.nih.gov

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.

Official title: Solid Organ Transplantation in HIV: Multi-Site Study

Study design: Observational, Natural History, Longitudinal, Defined Population, Prospective Study

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.

Minimum age: 1 Year. Gender(s): Both.

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

Allison Priore, Phone: (301) 451-3151, Email: AGirouard@niaid.nih.gov

Cedar-Sinai Hospital, Los Angeles, California 90035, United States; Recruiting
Sandy Leong, Phone: 310-423-5453, Email: leongs@cshs.org
Fred Poordad, MD, Principal Investigator
Nicholas Nissen, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94105, United States; Recruiting
Laurie Carlson, Phone: 415-353-8892, Email: CarlsonL@surgery.ucsf.edu
Annette Klemme, Phone: 415-353-8592, Email: klemmeA@surgery.ucsf.edu
Peter Stock, MD, Principal Investigator
Michelle Roland, MD, Principal Investigator

Georgetown University, Washington, District of Columbia 20007, United States; Recruiting
Dana Maglaris, Phone: 202-444-1769, Email: dxm01@gunet.georgetown.edu
Amy Lu, MD, Principal Investigator
Lynt Johnson, MD, Sub-Investigator

Washington Hospital Center, Washington, District of Columbia 20010-2975, United States; Recruiting
Peggy Cummings, Phone: 202-877-8946, Email: Peggy.W.Cummings@medstar.net
Jimmy Light, MD, Principal Investigator

University of Miami, Jackson Memorial Medical Center, Miami, Florida 33136, United States; Recruiting
Lois Hanson (kidney), Phone: 305-355-5048, Email: LHanson2@med.miami.edu
Debbie Wepler (liver), Phone: 305-585-6092, Email: DWeppler@med.miami.edu
Jorge Diego, MD, Principal Investigator
Dave Roth, MD, Principal Investigator
Andreas Tzakis, Principal Investigator
Arie Regev, Principal Investigator

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Beth Begley, Phone: 404-712-7168, Email: beth_begley@emoryhealthcare.org
Tom Pearson, MD, Principal Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Sara Rosenkoetter, Phone: 773-834-9796, Email: srosenko@medicine.bsd.uchicago.edu
Robert Harland, MD, Principal Investigator

Rush University, Chicago, Illinois 60612, United States; Recruiting
Rick T. Reyes, RN, Email: Richard_Reyes@rush.edu
Kristine Richards, RN, Phone: 312-942-9156, Email: kristine_l_richards@rush.edu
David Simon, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Sarah P. Hively-Johnson, Phone: 312-503-2607, Email: sphively@northwestern.edu
Tina Stosor, MD, Principal Investigator
Richard M Green, MD, Principal Investigator

Tulane University, New Orleans, Louisiana 70112, United States; Recruiting
Angela Solis, RN, Phone: 504-988-8260, Email: angela.solis@hcahealthcare.com
Brandy Haydel, Phone: 504-988-8260, Email: brandy.haydel@hcahealthcare.com
Sander Florman, MD, Principal Investigator
Douglas Slakey, MD, Principal Investigator

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Shannon Berg, Phone: 410-706-2125, Email: bergs@umbi.umd.edu
Robert Redfield, MD, Principal Investigator

Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Cynthia Cohen, CRNP, Phone: 410-502-3895, Email: ccohen@jhmi.edu
Aruna Subramanian, Principal Investigator

Beth Israel Deaconess, Boston, Massachusetts 02215, United States; Recruiting
Tina Healey, RN, Phone: 617-632-9813, Email: cshealey@bidmc.harvard.edu
Louise Riemer, RN, Phone: 617-632-9817, Email: lriemer@bidmc.harvard.edu
Douglas Hanto, MD, PhD, Principal Investigator
Michael Wong, MD, Principal Investigator

Columbia Presbyterian Hospital, New York, New York 10032, United States; Recruiting
Jane Cho, Phone: 212-305-3839, Email: jc2050@columbia.edu
Lorna Dove, MD, Principal Investigator
Jean Emond, MD, Principal Investigator

Mt. Sinai Medical Center, New York, New York 10029, United States; Recruiting
Inci Bijan, Phone: 212-659-8049, Email: inci.bijan@mountsinai.org
Barbara Murphy, MD, Principal Investigator

The University Hospital, Cincinnati, Cincinnati, Ohio 45219-2316, United States; Recruiting
Mike Alonzo, Phone: 513-475-8550, Email: mike.alonzo@uc.edu
Kenneth Sherman, MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Amy Daneri, Phone: 216-445-2116, Email: daneria@ccf.org
John Fung, MD, Principal Investigator

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States; Recruiting
Cynthia Gifford-Hollingsworth, MSN, CPNP, Phone: 215-762-8189, Email: cgiffor1@drexelmed.edu
Anil Kumar, MD, Principal Investigator
Burkhardt Ringe, MD, Principal Investigator
William Short, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Maryann Najdzinowicz, Phone: 215-662-4007, Email: maryann.najdzinowicz@uphs.upenn.edu
Kim Olthoff, MD, Principal Investigator
Emily Blumberg, MD, Principal Investigator

University of Pittsburgh, Thomas E. Starzl Institute, Pittsburgh, Pennsylvania 15213-2582, United States; Recruiting
Laurie Hope, RN, Phone: 412-692-2208, Email: hopelk@upmc.edu
Maggie Ragni, MD, Principal Investigator
Ronald Shapiro, Principal Investigator

University of Virginia, Charlottesville, Virginia 22908-0265, United States; Recruiting
Courtney Garbee, MS, Phone: 434-243-6156, Email: CFG2P@virginia.edu
Timothy Pruett, MD, Principal Investigator

Click here for participating centers, contact information, and additional information on this study

Related publications:

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.

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.

Starting date: October 2003
Last updated: September 17, 2007