UC makes $1 million dollar award for first study of kidney and liver transplants in HIV patients

A $1 million grant has been awarded by the Universitywide AIDS Research Program
of the University of California to conduct the first pilot study on liver and
kidney transplantation in persons with HIV infection.

The funds have been awarded to the University of California, San Francisco, to
study the safety, efficacy and long-term benefits of the transplant procedures
in up to seven HIV- infected patients receiving treatment at UC San Francisco.

Assemblywoman Carole Migden of San Francisco played a key role in authoring and
carrying the legislation for $1 million for research on liver and kidney
transplants for people with HIV. “People with HIV and AIDS are too often deemed
ineligible for organ transplants on the basis that more research needs to be
done,” Migden said. “This important research is needed to show whether organ
transplantation should be included in the list of procedures that are covered
by insurance payers for persons with HIV.”

AIDS Activist Jeff Getty, one of the most vocal proponents of organ transplants
for HIV-patients, said, “AIDs activists have been involved in the process of
developing this study every step of the way because we believe it is vitally
important. There are many people with HIV who are living longer and healthier
lives, yet we can see that organ failure is the next wave that is claiming
their lives. Until now, no one has done anything.”

Like all patients considered for transplant, the patients likely to be included
in this study are evaluated and placed on a waiting list.

The UC San Francisco study team is led by Peter Stock, MD, and Michelle Roland,
MD, physicians from the Departments of Surgery and Medicine, respectively, at

“We view this initial study as a proof of principle study,” Stock said. “While
we recognize that many people are in need of solid organ transplantation, such
procedures cannot be performed until and unless this ‘proof of principle’ is
established. Once that happens, many more centers and payers will be willing to
perform these procedures and provide reimbursement for them.”

Tom Coates, Ph.D., director of the UCSF AIDS Research Institute, said, “A
number of crucial scientific and clinical questions will be addressed in this
pilot study that can provide information to guide the safest management of
other HIV-positive people with end-stage kidney or liver disease. We are also
working with the National Institutes of Health and a group of collaborators
from transplant centers across the United States to discuss the feasibility of
a future national multi-center trial.”

“The results of this innovative and cutting-edge study are likely to help
persons with HIV in California as well as throughout the United States,” said
George Lemp, Dr. P.H., director of the Universitywide AIDS Research Program,
which allocated the funds.

Lemp explained, “Although the new combination therapies are extending the lives
of many persons with HIV, a substantial number now die from other causes, such
as end-stage liver and kidney disease. A careful study to demonstrate safety
and efficacy of organ transplantation in HIV-infected patients is essential
given the increasing numbers of HIV-infected persons confronted with end-stage
liver and kidney diseases.”

Indeed, a recent report from the Tufts University School of Medicine in
Massachusetts revealed that 50 percent of the 22 deaths among HIV-infected
patients treated at that institution in 1998-99 were attributable to end-stage
liver disease. Co-infection with hepatitis C virus, which can cause chronic
liver damage and failure, is often the reason for end-stage liver disease in
HIV-infected patients, although some deaths may result from the potential
toxicity of the combination drugs used in highly active antiretroviral therapy.

Current policy and practice have generally excluded HIV-infected individuals
with end-stage liver and kidney diseases from receiving transplants. The
concern has been that patients with HIV would have a poor prognosis because of
their shorter life expectancy and because their immune system already may have
been compromised due to their disease and the therapies used to treat HIV. It
was felt that organ transplants, which require lifelong suppression of the
immune system, would only worsen their condition.

However, recent advances in therapy have extended the life expectancy of many
with HIV, and recent but limited studies have indicated that some HIV infected
individuals could tolerate immunosuppressive treatments and benefit from
transplantation of organs.

The University of California established the Universitywide AIDS Research
Program in 1983 at the request of the state Legislature. The program, which is
part of the UC Office of the President in Oakland, has awarded a total of 1,600
research grants totaling more than $135 million.   

Jeff Getty can be reached for comment at (510) 653-6278
George Lemp is available for comment at (510) 987-9004
Peter Stock can be reached at (415) 353-1117 or via UCSF News Services (415)