Liver & Kidney Transplant in HIV Study
"SOLID ORGAN TRANSPLANTATION IN HIV: MULTI-SITE STUDY"
Hepatitis is a leading cause of death in HIV. HIV can accelerate disease progression of chronic hepatitis C & B. Hepatitis C is the leading reason for liver transplantation in the US. This study was designed to address the issues that HIV+ individuals have had difficulty in gaining access to liver & kidney transplants. Insurance reimbursement is difficult to obtain. There was not much clinical experience in transplants for liver & kidney in HIV until recent years. This recent but short term & preliminary research found HIV+ individuals can respond well to transplant. These recent findings and the outcome of this large study can help to overcome the barriers to access to liver & kidney transplantation.
The project is a cooperative effort with 17 centers, sponsored by UCSF and supported by NIAID/NIH and other sources. Our multidisciplinary team of investigators and clinicians from high volume transplant centers will support the project whose aim is to evaluate the safety and efficacy of solid organ transplantation in people with HIV disease by conducting a prospective, multi-center cohort study of HIV-positive (+) patients who undergo kidney or liver transplantation. Our long-range goals are:
* To provide patients and clinicians with information regarding the HIV-specific risks of transplantation,
* To provide clinicians with information necessary to manage immunosuppression and Antiretroviral (ARV) medications together, and
* To understand underlying basic science mechanisms that explain patient outcomes so that clinical management may be adjusted to maximize these outcomes.
The primary aim of this study is to evaluate the safety & efficacy of solid organ transplantation in people with HIV disease by conducting a prospective, multi-center cohort study of HIV+ patients who undergo kidney or liver transplantation.
You can go to the study website to read the entire study protocol.
If you are interested in transplantation for yourself or someone you know, please contact the study coordinator at the closest center.
This is an introductory letter from the study investigators:
Why is it time to study transplantation in people with HIV?
• People with HIV are living longer and doing better with their HIV.
Advances in HIV treatment with antiretroviral therapy have resulted in decreasing AIDS-related deaths. Unfortunately, as HIV-positive people are living longer, there are increasing numbers of deaths from organ failure, rather than AIDS-associated infections. While people with HIV infection have often been excluded from consideration for solid organ transplantation in the past, with the significant improvements in prognosis for people with HIV and AIDS, it is now time to generate adequate safety and efficacy data so that patients, transplant programs, and health insurers can re-evaluate this policy.
• People with HIV disease are at risk for kidney and liver diseases, just like people who do not have HIV.
Increasing numbers of patients with end-stage liver and kidney disease are seeking transplantation. Yet people with HIV infection have been considered ineligible for organ transplantation in the past for two important reasons. First, prior to the recent improvements in HIV treatment, people with HIV infection had a shortened lifespan as a result of their HIV. With the severe shortage of organs, transplant centers have made allocation decisions based in part on the likelihood of survival. Second, the immunosuppressive drugs required post-transplant to prevent organ rejection may worsen HIV-induced immune problems, causing rapid HIV disease progression and increased death rates.
• Poor survival from HIV is no longer a reason to deny a transplant to a person with well-treated HIV.
Highly active antiretroviral therapy (HAART) has changed the natural history of HIV infection in the developed world. People are living longer, healthier lives. Excluding people with HIV infection from consideration for organ transplantation based on the single criterion of length of survival can no longer be considered legitimate policy.
• Why is a study necessary?
In spite of the tremendous advances in the treatment of HIV disease, and the growing problems associated with end-stage organ failure among HIV-infected people, questions remain about the safety and efficacy of organ transplantation in people with HIV infection. Fortunately, small pilot studies are showing good outcomes. However, these findings need to be replicated in a larger, longer study for us to know with confidence that this is the right this to do and who might be at greater risk for not doing well with a transplant. In addition, it remains unknown how and to what extent anti-rejection therapies will interact with antiretroviral (ARV) medications. Understanding these drug interactions in HIV-positive transplant recipients will be essential to improving the management of anti-rejection therapy in the setting of HIV.
A study to evaluate the safety and effectiveness of kidney and liver transplants in a select population of HIV infected individuals is currently underway at 19 transplant centers across the country.
The "Solid Organ Transplantation in HIV: Multi-Site Study" is supported by the National Institute of Allergy and Infectious Diseases and sponsored by the University of California, San Francisco. To be eligible, patients must meet criteria for transplantation, have a CD4+ T-cell count > 200 (kidney) or > 100 (liver), and meet HIV viral load criteria depending on which organ is needed. Patients with certain opportunistic infections in the past will be considered at some centers.
• The study has a target enrollment of 150 kidney and 125 liver transplant recipients. We need to get the word out so people who are interested can join the study!
It is important that care providers and people with HIV facing organ failure be informed about this issue, the information available to date, and the status of the current study. The study has formed a Community Advisory Board (CAB) comprised of representatives of many stakeholder interests. Together, the CAB and investigators want to ensure that people with HIV infection and their care-givers are aware of this option.
For more information about this study, and for a complete list of participating centers, please visit the study website at http://spitfire.emmes.com/study/htr/.
Peter G. Stock, M.D.
Division of Transplant Surgery
University of CA, Moffitt Hospital
505 Parnassus Avenue.
San Francisco, CA 94143 Michelle Roland, M.D.
San Francisco General Hospital
Ward 84, Building 80
995 Potrero Avenue
San Francisco, CA 94110
For general project questions, please contact:
UCSF Project Manager
Email: email@example.com NIAID Project Manager
(K=Kidney, L=Liver, Peds=Pediatric Centers)
If you are interested in transplantation for yourself or someone you know, please contact the study coordinator at the closest center listed below.
Georgetown Medical Center
Amy Lu, Principal Investigator
Lynt Johnson, Co-Principal Investigator
Renee Loughlin, Coordinator
University of California,
(San Francisco, CA)
(K, L; Peds K, Peds L) Peter Stock, Principal Investigator
Michelle Roland Co-Principal Investigator
Laurie Carlson, Coordinator
University of Minnesota
Abhinav Humar, Principal Investigator
Arthur Matas, Co-Principal Investigator
Leslie Studenski, Coordinator
University of Pennsylvania
Kim Olthoff, Principal Investigator
Emily Blumberg, Co-Principal Investigator
Maryann Najdzinowicz, Coordinator
University of Virginia
Timothy Pruett, Principal Investigator
Meredith Gross, Coordinator
Cedars-Sinai Medical Center
(Los Angeles, CA)
(L) Fred Poordad, Principal Investigator
Nicholas Nissen, Co-Principal Investigator
Sandy Leong, Coordinator
University of Maryland
(K) Robert R. Redfield, Principal Investigator
Stephen Bartlett, Co-Principal Investigator
Onyinye Erondu, Coordinator
(K) Anil Kumar, Principal Investigator
Marjorie Hepler, Coordinator
University of Pittsburgh
Margaret Ragni, Principal Investigator
Ron Shapiro, Co-Principal Investigator
Holly Koff, Coordinator
Washington Hospital Center
(K) Jimmy Light, Principal Investigator
Diana Barhyte, Coordinator
Mount Sinai School of Medicine
(New York, NY)
(K, L; Peds K) Barbara Murphy, Principal Investigator
Thomas Dominic Schiano, Co-Principal Investigator
Charlene Toro, Liver Coordinator
Kristy Putnam, Kidney Coordinator
(New York, NY)
(L; Peds L) Jean Emond, Principal Investigator
Cabila Gomez-Picardo, Coordinator
University of Chicago
(K, L; Peds K, L) Robert Harland, Principal Investigator
Penny Pearson, Coordinator
University of Cincinnati
(K, L) Kenneth Sherman, Principal Investigator
Rita Alloway, Pharmacologist
Mike Alonzo, Liver Coordinator
University of Miami
(K) Jorge Diego, Principal Investigator
Dave Roth, Co-Principal Investigator
Ann Rosen, Coordinator
Beth Israel Deaconess Medical Center
Douglas W. Hanto, Principal Investigator
Michael Wong, Co-Principal Investigator
Nina Grenon, Coordinator
(K) Tom Pearson, Principal Investigator
Bethany Lane, Coordinator
The EMMES Corporation
Please address all Questions and Comments about this web site to:
Data Coordinator/Protocol Manager
The EMMES Corporation
401 N. Washington Street,
Rockville, MD 20850
Phone: (301) 251-1161
Fax: (301) 251-1355