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Summary of Trials for Liver and Kidney Transplant Patients

Liver and Kidney Transplant Patients


Title:
Kidney and Liver Transplantation For People with HIV: A Multi-Site Study

BIDMC Principal Investigator - Transplant Surgeon, Douglas Hanto, MD, PhD

Type of Study - Observational Study

Trial Status - Active but closed to enrollment

Sponsor - National Institutes of Health

BIDMC Contact Person: Susan McDermott, RN, MPH: 617.632.9841 or smcderm2@bidmc.harvard.edu

Why is This Study Being Done? - People with HIV infection are at risk for kidney and liver disease for the same reasons that people without HIV infection are at risk. They also may be at increased risk because of HIV-related kidney or liver disease or due to viral infections such as hepatitis B or hepatitis C. Due to improvements in the treatment of HIV, HIV-infected patients may now be better candidates for organ transplant. In the past, people with HIV infection have often not been offered a transplant because of concerns that the anti rejection drugs (immunosuppressants) required after organ transplantation might worsen the patient's HIV infection. This concern is a major focus of this study.

The purpose of this study is to evaluate safety and efficacy of kidney and liver transplantation for people who have HIV disease. The study's long-range 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 antiretroviral (ARV) medications together; and

3. to better understand the basic scientific mechanisms to improve clinical management.

What's Involved? - Patients are invited to participate in the study at the time of their evaluation for transplant. After transplant, additional blood and urine samples are collected for study purposes. Otherwise, management of care is specific to the each transplant center's standard practice. Participants are followed for 5 years post transplant. Study visits are scheduled to coincide with regular care appointments at the Transplant Center.

Find out More on the National Clinical Trials Registry: This study and other clinical trials are included in the National Clinical Trials Registry, which summarizes information about a clinical trial's purpose, who may participate, trial site locations, and contact phone numbers. Related research publications and study results are also posted to the Registry site as they become available.

 Use this link to read more about this study on the National Clinical Trials Registry: http://clinicaltrials.gov/ct2/show/NCT00074386