HIV-positive patients may be eligible for kidney transplants despite the fact they have the virus that causes AIDS. Due to therapeutic advances in HIV/AIDS care, those with the AIDS virus now can be considered as candidates for a multi-center five-year clinical trial evaluating the safety and effectiveness of this life-saving procedure in HIV-infected patients.
"Until recently, people with HIV infection have not been considered as eligible candidates for this procedure due to concerns that the immune system suppression required for organ transplantation might worsen the patient's HIV infection and, potentially, be fatal," says Dr. Robert Redfield, director of the Clinical Care & Research Division of the Institute of Human Virology in Baltimore, Md.
"With the advent of combination therapies, however, HIV-infected patients are living healthier and longer lives. A growing number, in fact, are dying from consequences of end stage kidney and liver disease rather than AIDS-related infections and tumors. Due to the therapeutic advances in treatment of HIV infection, these same patients may now be better candidates for a kidney transplant," Dr. Redfield adds.
Despite the fact that HIV-positive patients historically could not be considered eligible for solid organ transplant, some had undergone this life-saving procedure before being diagnosed with the virus that causes AIDS. Their experiences provided pilot data that paved the way for the current clinical trial being conducted jointly by the Institute of Human Virology and the University of Maryland Medical Center.
This study, funded by the National Institutes of Health, will evaluate whether post-transplant medications used to prevent the body from rejecting the new kidney negatively affect HIV infection; whether HIV infection negatively affects the transplanted kidney; and how antiretrovirals (drugs used to treat HIV) and the anti-rejection drugs interact with each other.
Approximately 75 patients will be enrolled nationwide; one-third of them at the University of Maryland Medical Center, with which the IHV is affiliated, and which performs more kidney transplants than any other center in the United States.
Dr. Stephen T. Bartlett, co-principal investigator for the study, head of the University of Maryland Medical Center's Division of Transplantation Surgery and professor of surgery at the University of Maryland School of Medicine, has been a pioneer in the development of new treatment strategies for patient populations previously denied transplantation. The Maryland transplant team also has pioneered minimally invasive surgery for kidney donation by living donors, potentially a significant benefit for those study participants who have identified a living donor. This study, evaluating how to best manage HIV-infected patients who undergo kidney transplantation, will utilize kidneys both from living donors and cadavers.
Eligibility requirements include documented HIV infection (by any licensed ELISA and confirmation by the Western Blot), current CD4+ T-cell counts at or above 200/mL for the past six months, HIV-1 RNA less than 50 copies/mL for three months. Patients must meet standard listing criteria for placement on a transplant waiting list and must be able to provide informed consent and participate in close clinical follow-up for blood tests and various examinations over a five-year period of time.
"Findings presented just last week at the International Congress of the Transplantation Society meeting indicate that HIV-positive patients are just as likely to survive solid organ transplantation as other transplant recipients. And the waiting list has been growing for years," says Dr. Redfield, who adds that more than 25 patients already are on a waiting list at the Institute of Human Virology. Further testing could help solidify preliminary data, he adds, and validate insurance coverage for the life-saving procedure, which averages approximately $75,000 per transplant.
Other participating centers include the University of California - San Francisco, Cornell University, Duke University, Georgetown University, Mount Sinai School of Medicine, University of Minnesota, University of Pittsburgh, University of Virginia and Washington Hospital Center.
Those interested in the IHV/UMMC clinical trial can contact 410-706-1476 or 410-706-1684.
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