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Kidney and Liver Transplantation in People with HIV Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Kidney and Liver Transplantation in People with HIV conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Kidney and Liver Transplantation in People with HIV Clinical research trials and Kidney and Liver Transplantation in People with HIV medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Kidney and Liver Transplantation in People with HIV. Kidney and Liver Transplantation in People with HIV Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Kidney and Liver Transplantation in People with HIV clinical trial. Test subjects typically obtain the finest healthcare available for their Kidney and Liver Transplantation in People with HIV condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "K" Clinical Trials Conditions > Kidney and Liver Transplantation in People with HIV  Kidney and Liver Transplantation in People with HIV
Kidney and Liver Transplantation in People with HIV
For Condition: Kidney Transplantation,Liver Transplantation,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 1 Year/
Genders: Both
Protocol Entry 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
Total Enrollment: 275
Location and Contact Information:
Overall Study Official:
PeterStock, Principal Investigator, University of California, San Francisco
Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Kim Baio 404-712-7168
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Maryann Najdzinowicz 215-662-4007
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Lisa Pulkrabek 612-624-2433
Columbia Presbyterian Hospital *Recruiting*
New York City, New York, 10032
United States
Recruiting Claudia Musat 212-342-0258
University of California, San Francisco *Recruiting*
San Francisco, California, 94105
United States
Recruiting Laurie Carlson 415-502-8322
Washington Hospital Center *Recruiting*
Washington D.C., District of Columbia, 20010-2975
United States
Recruiting Diana Barhyte 202-877-8948
Georgetown University *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Leslie Broseker 202-444-6043
University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Camille Carter 410-706-2125
University of Pittsburgh, Thomas E. Starzl Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213-2582
United States
Recruiting Deborah Mayher 412-648-3309
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Valerie Hansen 773-702-3244
The University Hospital, Cincinatti *Recruiting*
Cincinnati, Ohio, 45219-2316
United States
Recruiting Mike Alonzo 513-584-0985
Mt. Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting Jenny Figueroa 212-659-8053
Drexel University College of Medicine *Recruiting*
Philadelphia, Pennsylvania, 19102
United States
Recruiting Camran Farahani 215-762-7974
Beth Israel Deaconess *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Tina Seminara 617-632-9813
University of Miami, Jackson Memorial Medical Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Ann Rosen 305-585-5454
Cedars-Sinai *Recruiting*
Los Angeles, California, 90035
United States
Recruiting Sandy Leong 310-423-5453
University of Virginia *Recruiting*
Charlottesville, Virginia, 22908-0265
United States
Recruiting Terry Ryan 434-982-3665
Additional Information:
Study ID Numbers: 1U01AI052748;
Study Start Date: October 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074386
Other Hiv Infections Studies:
1. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
2. Kidney and Liver Transplantation in People with HIV
Related Studies:
Other HIV Infections Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Kidney and Liver Transplantation in People with HIV
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