MVC is a CCR5 inhibitor that may have a positive role in modulating the immune response
following transplantation. The purpose of this study is to evaluate the safety and
tolerability of MVC in HIV-infected adults in need of a kidney transplant. The study will
also evaluate whether using both immunosuppressant drugs and MVC will improve kidney
function after a kidney transplant.
This study will enroll HIV-infected adults on combination antiretroviral therapy (cART) who
need a kidney transplant. At the time of their kidney transplant, study participants will be
randomly assigned to receive either MVC or placebo as an addition to their cART regimen.
(MVC or placebo will be provided by the study. However, the HIV medicines in their cART
regimens will not be provided by the study.) Participants will receive MVC or placebo
throughout their participation in the study, which will be 1 to 3 years depending on when
they enroll in the study.
Study visits will occur at enrollment (Day 0) and post-transplant Weeks 1, 2, 4, 8, 13, 26,
39, 52, 78, 104, 130, and 156. Study visits may include a physical examination, blood
collection, lymph node collection, and a kidney biopsy. During the study, participants will
also be monitored closely for evidence of drug toxicities, HIV treatment failure and