97
Participants
Start Date
January 1, 2017
Primary Completion Date
May 10, 2022
Study Completion Date
May 10, 2022
Maraviroc
"Initial dose of 300 mg twice daily (150mg twice daily if co-prescribed with a potent CYP3A inhibitor or 600mg twice daily if co-prescribed with a potent CYP3A inducer). Will be modified if GFR \< 30, if co-prescribed with a potent CYP3A inhibitor or inducer, or if the calcineurin inhibitor used for maintenance immunosuppression is changed to cyclosporine (which is only allowed for tacrolimus toxicity).~Once GFR is greater than or equal to 30, the dose should be returned to the non-renal dosage. If GFR is consistently fluctuating (especially immediately post-transplant), the site investigator may choose when to resume normal dosing of study product based on clinical assessment of stability."
Placebo
"Initial dose of 300 mg twice daily (150mg twice daily if co-prescribed with a potent CYP3A inhibitor or 600mg twice daily if co-prescribed with a potent CYP3A inducer). Will be modified if GFR \< 30, if co-prescribed with a potent CYP3A inhibitor or inducer, or if the calcineurin inhibitor used for maintenance immunosuppression is changed to cyclosporine (which is only allowed for tacrolimus toxicity).~Once GFR is greater than or equal to 30, the dose should be returned to the non-renal dosage. If GFR is consistently fluctuating (especially immediately post-transplant), the site investigator may choose when to resume normal dosing of study product based on clinical assessment of stability."
Mt. Sinai Med. Ctr. HIVTR-CCR5 Non-Network CRS, New York
Univ. of Penn HIVTR-CCR5 Non-network CRS, Philadelphia
Georgetown HIVTR-CCR5 Non-Network CRS, Washington D.C.
Univ. of Maryland HIVTR-CCR5 Non-Network CRS, Baltimore
JHU HIVTR-CCR5 Non-Network CRS, Baltimore
Emory HIVTR-CCR5 Non-Network CRS, Atlanta
UCLA HIVTR-CCR5 Non-Network CRS, Los Angeles
UCSF HIVTR-CCR5 Non-network CRS, San Francisco
UAB HIVTR-CCR5 Non-Network CRS, Birmingham
Northwestern HIVTR-CCR5 Non-Network CRS, Chicago
National Institute of Allergy and Infectious Diseases (NIAID)
NIH