Tom Pearson Emory-Pi of Study of FDA-Approved Drug in HIV Positive Patients Receiving Kidney Transplants
Thomas Pearson, MD, professor of surgery and executive director of the Emory Transplant Center, is principal investigator of the Emory site in a multi-center, prospective, double-blind phase II study of the impact of CCR5 blockade in HIV-infected adults receiving a kidney transplant. This $1.6 million research study for all 10 sites combined is supported by the National Institute of Allergy and Infectious Diseases.
The CCR5 receptor is an entrance point for HIV into cells of the immune system. Maraviroc (MVC), the generic name of the antiretroviral drug that is currently FDA-approved for the treatment of HIV infection, is the CCR5 blocker being studied. The investigators will evaluate the safety and tolerability of MVC in HIV-infected adults in need of a kidney transplant, and whether using both immunosuppressant drugs and MVC will improve kidney function after a kidney transplant. While CCR5 blockade is currently used in combination with other drugs to control HIV infection, it has not been studied at the time of transplantation in HIV positive individuals.
A total of 130 participants with well-controlled HIV infection (they must be on an antiretroviral regimen for at least three months) and in need of a kidney transplant will be enrolled in the study. Eleven patients will be enrolled at the Emory site. At all sites, participants will only receive kidneys from donors who are not infected with HIV. At the time of transplant, the study participants will be randomized to receive MVC or 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).
"Besides testing CCR5 for safety and tolerability, we will also study its effects on quieting the immune response to transplant in HIV positive patients," Pearson explains. "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.