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