Registered clinical trials on CCR antagonists (other than CVC) in patients with NAFLD

ID, registration date (DD/MM/YYYY)* Title Design Arms Patients (n) Duration Primary outcome(s)
ISRCTN31461655, 23/02/2018 A phase IV, open-label pilot study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomized to receiving optimized background therapy (OBT) plus maraviroc or OBT Multicenter, randomized, open-label, phase 4 MVC (NA mg) vs. No treatment (ART only) 60 24 months 1) Number of participants with adverse events
2) Adherence to MVC treatment (questionnaire)
3) Parameters related to the participation and missing values
EUC-TR2017-003172-32, 06/02/2018 Maraviroc Add-On Therapy for Steatohepatitis in HIV (MASH study) Multicenter, non-randomized, open-label, phase 2 MVC (150 mg) vs. MVC (300 mg) 30 12 months Change in hepatic immune cells identified on liver biopsy (immuno-histochemistry)
NCT03129113, 26/04/2017 EUC-TR2016-003575-21, 09/05/2018 A Multicentre, 48 Week Randomized Controlled Factorial Trial of Adding Maraviroc and/or Metformin for Hepatic Steatosis in HIV-1-infected Adults on Combination Antiretroviral Therapy (MAVMET) Multicenter, randomized, open label, phase 2 MVC (NA mg) vs. Metformin (500 mg) vs. MVC (NA mg) + Metformin 500 mg) vs. No treatment (ART only) 90 12 months Change in percentage of liver fat, measured by MR-PDFF

References are presented in date of registration order (newer to older); ART: antiretroviral treatment; HIV: human immunodeficiency virus; MR-PDFFl: magnetic resonance spectroscopy measuring the hepatic proton density fat fraction; MVC: Maraviroc; NA: not available; OBT: optimized background therapy