Kidney and Liver Transplantation in People With HIV
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00074386 |
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Recruitment Status
:
Completed
First Posted
: December 15, 2003
Last Update Posted
: January 17, 2014
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| Condition or disease |
|---|
| HIV Infections Kidney Disease Liver Disease |
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.
| Study Type : | Observational |
| Actual Enrollment : | 275 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Solid Organ Transplantation in HIV: Multi-Site Study |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | August 2013 |
- Subject survival [ Time Frame: 5 years ]
- graft survival [ Time Frame: 5 years ]
- Opportunistic complications [ Time Frame: 5 years ]
- CD4+ T cell counts and HIV-1 RNA levels [ Time Frame: 5 years ]
- 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 ]
- rejection rates and markers of alloresponse [ Time Frame: 5 years ]
- pharmacokinetic interactions between immunosuppressive agents and antiretrovirals [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 1 Year and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074386
| 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 | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| 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 | |
| Principal Investigator: | Peter Stock, MD | University of California, San Francisco | |
| Principal Investigator: | Michelle Roland | University of California, San Francisco |
Additional Information:
Publications of Results:
Other Publications:
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 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 15, 2003 Key Record Dates |
| Last Update Posted: | January 17, 2014 |
| Last Verified: | January 2014 |
Keywords provided by University of California, San Francisco:
|
HIV Transplant Liver Kidney |
Organ Treatment Experienced Kidney Transplant Liver Transplant |
Additional relevant MeSH terms:
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HIV Infections Kidney Diseases Liver Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Urologic Diseases Digestive System Diseases |