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
MD, KP, AP: design of the review, drafting the manuscript; JK: design of the review, critical revision of the manuscript; SAP: conception and design of the review, drafting and critical revision of the manuscript; all the authors: final approval of the version to publish, agreeing to be accountable for all aspects of the work.
The authors declare that they have no conflicts of interest.
© The Author(s) 2020.