The Emory Transplant Center will soon begin enrolling HIV (human immunodeficiency virus) positive patients in need of a kidney transplant into a new clinical trial to evaluate the safety and tolerability of a drug that blocks the CCR5 receptor. The CCR5 receptor is an entrance point for HIV into cells of the immune system. The drug being studied, generic name maraviroc, is an antiretroviral drug currently FDA-approved for the treatment of HIV infection.
Ten centers across the U.S. are involved in this prospective, double-blind, Phase II 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 arms: In one arm, 65 patients will receive maraviroc and in a second arm, 65 patients will receive 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. At all sites, participants will only receive kidneys from donors who are not infected with HIV.
“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.” 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.
“Besides testing CCR5 for safety and tolerability, we will also study its effects on quieting the immune response to transplant in HIV positive patients,” explains Pearson. “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.”
All participants in the study will receive immunosuppressive medications following their transplant, as any transplant patient would. They will be followed for up to three years after transplant.
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).