Clinical Trial: Kidney and Liver Transplantation in People with HIV

This study is currently recruiting patients.

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

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 Treatment or Intervention
HIV Infections
Kidney Transplantation
Liver Transplantation
 Procedure: Kidney Transplantation
 Procedure: Liver Transplantation

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  275

Study start: October 2003

Patients with HIV infection are at significant risk for end stage organ disease. Prior to the advent of highly active antiretroviral therapy (HAART), such patients were often not considered transplant candidates based on poor prognosis. However, with the use of HAART, HIV infected patients have experienced significant improvements in morbidity and mortality. HIV infected patients 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 disease by following a prospective, multi-center cohort of HIV infected patients 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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • HIV infection
  • Undetectable HIV viral load (generally, less than 50 copies/ml) for at least 3 months prior to study entry
  • On the same HIV treatment drugs without any changes for at least 3 months prior to study entry, or have had undetectable viral load without drugs for the entire course of infection
  • Meet all eligibility requirements for a transplant (same requirements that HIV uninfected patients must meet)
  • Willing to take medication to prevent certain infections
  • If participant has hepatitis B or C, willing to undergo frequent monitoring, including liver biopsies, and treatment
  • 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 for the 6 months prior to study entry for adults. 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 for the 6 months prior to study entry for adults. 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:

  • Pregnancy
  • Significant wasting

Location and Contact Information

Natasha Watson      301-435-4420    nwatson@niaid.nih.gov
Rodney Rogers      415-514-2194    rogersr@surgery.ucsf.edu

California
      Cedars-Sinai, Los Angeles,  California,  90035,  United States; Recruiting
Sandy Leong  310-423-5453    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  415-353-8892    CarlsonL@surgery.ucsf.edu 
Peter Stock, MD,  Principal Investigator
Michelle Roland, MD,  Principal Investigator

District of Columbia
      Georgetown University, Washington,  District of Columbia,  20007,  United States; Recruiting
Leslie Broseker  202-444-6043    laa29@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
Diana Barhyte  202-877-8948    diana.y.barhyte@medstar.net 
Jimmy Light, MD,  Principal Investigator

Florida
      University of Miami, Jackson Memorial Medical Center, Miami,  Florida,  33136,  United States; Recruiting
Ann Rosen  305-585-5454    arosen@med.miami.edu 
Jorge Diego, MD,  Principal Investigator
Dave Roth, MD,  Principal Investigator

Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Kim Baio  404-712-7168    kim_baio@emoryhealthcare.org 
Vicki Carol  404-727-1625    vicki_carroll@emoryhealthcare.org 
Tom Pearson, MD,  Principal Investigator

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Penny Pearson  773-934-9796    ppearson@medicine.bsd.uchicago.edu 
Kim Rusk  773-702-5457    krusk@medicine.bsd.uchicago.edu 
Robert Harland, MD,  Principal Investigator

Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
Onyinye Erondu  410-706-5487    erondu@umbi.umd.edu 
Robert Redfield, MD,  Principal Investigator

Massachusetts
      Beth Israel Deaconess, Boston,  Massachusetts,  02215,  United States; Recruiting
Nina Grenon, RN  617-632-9700    ngrenon@bidmc.harvard.edu 
Douglas Hanto, MD, PhD,  Principal Investigator
Michael Wong, MD,  Principal Investigator

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Leslie L. Studenski  612-624-2433    debel1003@umn.edu 
Isaac Johnson  612-624-6649    john4472@umn.edu 
Abhinav Humar, MD,  Principal Investigator
Arthur Matas, MD,  Principal Investigator

New York
      Columbia Presbyterian Hospital, New York,  New York,  10032,  United States; Recruiting
Cabilia Gomez-Picardo  212-342-0426    cgp2101@columbia.edu 
Lorna Dove  212-305-0914    lmd62@columbia.edu 
Jean Emond, MD,  Principal Investigator

      Mt. Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Charlene Toro - Liver  212-659-8049    carlene.toro@msnyuhealth.org 
Kristy Putnam - Kidney  212-659-8044    Kristy.Putnam@msnyuhealth.org 
Barbara Murphy, MD,  Principal Investigator

Ohio
      The University Hospital, Cincinatti, Cincinatti,  Ohio,  45219-2316,  United States; Recruiting
Mike Alonzo - Liver  513-584-0985    mike.alonzo@uc.edu 
Martha Kidd - Kidney  513-584-1173    kiddm@ucmail.uc.edu 
Kenneth Sherman, MD,  Principal Investigator

Pennsylvania
      Drexel University College of Medicine, Philadelphia,  Pennsylvania,  19102,  United States; Recruiting
Marjorie Hepler  215-762-4429    marjorie.e.hepler@drexel.edu 
Regina Anthony  215-762-3251    rla24@drexel.edu 
Anil Kumar, MD,  Principal Investigator

      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Maryann Najdzinowicz  215-662-4007    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
Holly Chapman  412-648-3309    chapmanhl@upmc.edu 
John Fung,  Principal Investigator

Virginia
      University of Virginia, Charlottesville,  Virginia,  22908-0265,  United States; Recruiting
Meredith Gross  434-243-6156    MPG8B@hscmail.mcc.virginia.edu 
Timothy Pruett, MD,  Principal Investigator

Study chairs or principal investigators

Peter Stock, MD,  Principal Investigator,  University of California, San Francisco   

More Information

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

Study ID Numbers:  1U01AI052748
Record last reviewed:  November 2004
Last Updated:  November 3, 2004
Record first received:  December 11, 2003
ClinicalTrials.gov Identifier:  NCT00074386
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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