Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

May 10, 2022

Study Completion Date

May 10, 2022

Conditions
HIV InfectionsKidney Diseases
Interventions
DRUG

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."

DRUG

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."

Trial Locations (10)

10029

Mt. Sinai Med. Ctr. HIVTR-CCR5 Non-Network CRS, New York

19104

Univ. of Penn HIVTR-CCR5 Non-network CRS, Philadelphia

20007

Georgetown HIVTR-CCR5 Non-Network CRS, Washington D.C.

21201

Univ. of Maryland HIVTR-CCR5 Non-Network CRS, Baltimore

21287

JHU HIVTR-CCR5 Non-Network CRS, Baltimore

30322

Emory HIVTR-CCR5 Non-Network CRS, Atlanta

90024

UCLA HIVTR-CCR5 Non-Network CRS, Los Angeles

94118

UCSF HIVTR-CCR5 Non-network CRS, San Francisco

35233-2060

UAB HIVTR-CCR5 Non-Network CRS, Birmingham

60611-2927

Northwestern HIVTR-CCR5 Non-Network CRS, Chicago

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02741323 - Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter