Clinical Trial Details

Trial ID: L0509
Source ID: ISRCTN31461655
Associated Drug: Maraviroc
Title: A pilot study to investigate whether adding maraviroc to existing therapy has any effect for people with HIV and fatty liver disease
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: HIV and fatty liver disease <br>Infections and Infestations <br>Human immunodeficiency virus [HIV] disease
Interventions: <br> The trialists plan to recruit people with well controlled HIV (that is, an undetectable viral load) and evidence of NAFLD on a scan, who attend care at Brighton and Sussex University Hospitals NHS Trust.<br><br> The web-
Outcome Measures: <br> Current primary outcome measure as of 02/02/2022:<br> 1. Proportion of eligible individuals approached who are successfully recruited using MACRO electronic case report form at week 96<br> 2. Monthly participant recruitment rate collected by completed CRFS up to recruitment completion 07/01/2020<br> 3. Participant retention collected through eCRF completion in the study at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 4. Proportion of participants for whom there is missing data collected by eCRF at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 5. Proportion of participants reporting adverse events collected by eCRF at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 6. Level of self-reported adherence to the study drug as collected by patient questionnaire at 48 and 96 weeks in those allocated to the maraviroc group<br><br><br> Previous primary outcome measure:<br> 1. Proportion of eligible individuals approached who are successfully recruited using MACRO electronic case report form at week 96<br> 2. Monthly participant recruitment rate collected by completed CRFS up to recruitment completion 30/09/2019<br> 3. Participant retention collected through eCRF completion in the study at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 4. Proportion of participants for whom there is missing data collected by eCRF at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 5. Proportion of participants reporting adverse events collected by eCRF at 48 and 96 weeks in the maraviroc and non-maraviroc assigned groups<br> 6. Level of self-reported adherence to the study drug as collected by patient questionnaire at 48 and 96 weeks in those allocated to the maraviroc group<br> <br> 1. ELF score using ELF blood test at baseline, 48 and 96 weeks<br> 2. Fibroscan stiffness fibroscan test at baseline, 48 and 96 weeks<br> 3. Fibroscan Controlled Attenuation Parameter (CAP) using fibroscan test score at baseline, 48 and 96 weeks<br> 4. % with a CT liver: spleen attenuation ratio <1.0 measured using patient notes and CT of liver at baseline and 96 weeks<br> 5. Blood-derived biochemistry (fasting HDL:chol ratio, LDL, HDL, TG, glucose, plus Hb1AC and ALT) measured using blood test at baseline, 48 and 96 weeks<br> 6. Clinical signs of the metabolic syndrome (BMI, waist circumference and weight) measured at baseline, 48 and 96 weeks<br> 7. HIV parameters (CD4 cell count and % with undetectable HIV VL) measured using a blood test at baseline, 24, 48, 72, 96 weeks<br> 8. Quality of life assessed using the chronic liver disease questionnaire for NAFLD (CLDQ:NAFLD), and the SF-36 and WPAI:SHP questionnaires at baseline, 48 and 96 weeks<br>
Sponsor/Collaborators: University Hospitals Sussex NHS Foundation Trust
Gender: All
Age: nannan
Phases: Phase 4
Enrollment: 60
Study Type: Interventional
Study Designs: Randomised; Interventional; Design type: Treatment, Drug (Treatment)
Start Date: 23/02/2018
Completion Date: 30/03/2022
Results First Posted: --
Last Update Posted: 21 February 2022
Locations: United Kingdom;England
URL: https://www.isrctn.com/ISRCTN31461655