Emory Transplant Center will soon begin enrolling patients into a new clinical trial that will test an FDA-approved drug in HIV positive patients receiving a kidney transplant. The research study will evaluate the safety and tolerability of a drug that blocks the CCR5 receptor. The CCR5 receptor is an entry point that allows HIV into the cells of the immune system. The drug being studied, generic name maraviroc, is an antiretroviral drug that helps block the virus from entering these cells. It is currently FDA-approved for the treatment of HIV infection.
Emory will be one of ten centers across the U.S. that will be play a part in this study. A total of 130 participants with well-controlled HIV infection (must be on an antiretroviral regimen for at least three months) will be randomized into one of two study groups. In the first group, patients will receive maraviroc, with the second group receiving a placebo. Neither doctors nor patients will know if the kidney recipients are receiving the study drug or the placebo (known as the standard of care). Up to 11 participants will be enrolled at Emory.
This $1.6 million research study for all 10 sites combined is supported by the National Institute of Allergy and Infectious Diseases (ClinicalTrials.gov Identifier: NCT02741323).
“When it comes to transplanting organs in HIV positive patients, it is known that these patients have more rejection and more severe rejection than non-HIV transplant recipients,” says Thomas Pearson, MD, DPhil, professor of surgery, and executive director of the Emory Transplant Center. “This is likely because their immune systems are dysregulated and some components are overactive. This may contribute to the high rate of transplant rejection.” Dr. Pearson is the principal investigator of the Emory clinical trial.
CCR5 blockade is currently used in combination with other drugs to control HIV infection, but it has not been studied at the time of transplantation in HIV positive individuals.
“This clinical trial will help us better understand the drug’s effects on renal function at 52-weeks post-transplant and if the drug can have a dual effect in controlling the HIV infection and improving kidney transplant outcomes,” explains Dr. Pearson.
All study participants will receive immunosuppressive medications following their transplant, as any transplant patient would. Participants will be followed for up to three years after transplant.