Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients

Northwestern University will be one of 10 transplant centers from across the country participating in this multi-site study investigating the impact of CCR5 blockade with maraviroc in kidney transplant recipients with HIV. Each participating transplant center will screen, enroll, and transplant patients per the IRB approved study protocol. We expect a total of 120 kidney transplants in HIV positive recipients to be performed in this study from all participating transplant centers (60 on maraviroc + 60 on placebo). In addition, for each HIV+ subject enrolled in the study at each center, an HIV negative control case will be enrolled for mechanistic analysis only (120 total). The HIV negative control cases will have limited follow-up and will not require the same amount of effort/data entry as the HIV positive treatment arm. Controls will be enrolled 1:1 at each center. The budget for each center is based on a predicted number of transplants per year. The budget for Northwestern University is based on the prediction that 2 HIV+ kidney subjects will be transplanted in year one, 3 in year two, 4 in year three, and 1 in year four. Each subject will be followed for 1 - 3 years. In addition, the same number of HIV- control cases for mechanistic analysis will be enrolled each year as well. Continued funding in subsequent fund years will be contingent upon review of the predicted number of transplants used to set up the budget, and actual subjects screened, transplants performed, and data management and site monitoring performance.