| Outcome Measures: |
Main Objective: Does maraviroc change the inflammatory cell infiltrate in the livers of patients with HIV infection and non-alcoholic steatohepatitis?;Secondary Objective: Does Maraviroc have an impact on:<br>1. metabolic parameters e.g. insulin resistance and diabetes, blood pressure<br>2. Circulating inflammatory signals in the blood (cytokines and adiopkines)<br>3. The severity of non-alcoholic steatohepatitis on the liver biopsy, scored by histopathologists using a score called the NAFLD Activity Score ('NAS' Score)<br>4. Non- invasive markers of liver fibrosis<br>5. Levels of liver enzymes in the blood (the standard clinical biochemical tests to assess liver function)<br>6. Create a high- quality biobank repository of samples from patients with well characteristed NAFLD and HIV mono-infection.;Primary end point(s): A change in hepatic immune cells- including CD3+, CD4+, CD8+, T-bet+, CD56, CD68, CD163 and myeloperoxidase positive cells identified on liver biopsy tissue using immunohistochemistry- following 48 weeks MVC therapy. ;Timepoint(s) of evaluation of this end point: Compare values at baseline (within 12 months before enrollment) with values after 48 weeks treatment.Secondary end point(s): 1. Improvement in biochemical (fasting glucose, lipids and HOMA index) metabolic parameters at EOT as compared to baseline.<br>2. Modification of circulating inflammatory cytokines, adipokines and markers of macrophage activation (high sensitive IL6, sTNFR1 /2, sCD14, sCD163, hsCRP, Leptin, Total and High molecular weight adiponectin) at EOT as compared to baseline.<br>3. Number of subjects with a reduction in the NAS score by =2 points without worsening of fibrosis at EOT as compared to baseline.<br>4. Number of subjects with a reduction in the degree of liver steatosis, inflammation and/or ballooning at EOT as compared to baseline<br>5. Number of subjects with a reduction of at least one stage of liver fibrosis in patients with fibrosis at EOT as compared to baseline<br>6. Number of subjects with a reduction of Fibroscan?? values and biochemical markers of fibrosis (APRI, Fib-4, NAFLD Fibrosis Score[5]) from at EOT as compared to baseline<br>7. Number of subjects with normalization of Fibroscan values at the EOT<br>8. Number of subjects with a reduction in liver transaminases (ALT and AST) levels during the course and the EOT<br>9. Additional stool and urine samples will be collected at baseline and EOT and stored in Imperial College Gastroenterology and Hepatology Biobank for analysis of the impact of the intestinal microbiome and associated metabolic biomarkers on the progression of NAFLD/NASH in HIV. <br>;Timepoint(s) of evaluation of this end point: Compare values at baseline with values after 48 weeks treatment.
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