Investigating the impact of Maraviroc on liver inflammation in patients with HIV and fatty liver disease

Phase 2

Completed

• Conditions: Specialty: Hepatology, Primary sub-specialty: Hepatology; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of liver, Infection/ Human immunodeficiency virus [HIV] disease; Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN15410818
• Lead Sponsor: Imperial College of Science, Technology and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Study Completion: 2020-03-01
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. HIV-1 infected individuals (males and females) aged 18-75 years
2. Stable antiretroviral therapy for at least one year on a regimen that is unlikely to change in the next 12 months
3. At least two consecutive undetectable HIV viral loads defined by HIV RNA =50 copies/mm3 for at least 6 months prior to the date of inclusion
4. CD4 count = 200 cells/mm3
5. Histological evidence of NASH based on liver histology performed within 12 months prior to visit 1 (Week 0) with a NAFLD activity score (NAS) = 4 with a score of at least 1 in each component (steatosis, lobular inflammation, and hepatocyte ballooning)[26] and <10% weight loss since the time of liver biopsy (see appendix 2 for criteria for offering liver biopsy)
6. Consent to second liver biopsy after 48 weeks treatment with MVC.
7. Patient able to understand and sign a consent form

Exclusion Criteria

Liver co-morbidities:
1. Positive HBs antigen (HBsAg)
2. Positive HCV antibody (HCVAb), with the exception of subjects with the presence of HCVAb but negative hepatitis C virus RNA without treatment (i.e. spontaneous clearance following acute infection).
3. Underlying acute or chronic liver disease including non- B non- C viral hepatitis (A & E), autoimmune liver disease, biliary disease, hemochromatosis, Wilson´s disease, alpha-1-antitrypsin deficiency.
4. History of decompensated cirrhosis including ascites, hepatic encephalopathy, or variceal bleeding.
5. Suspicion of drug-related toxicity defined by abnormal LFTs following the recent introduction of a new medication.

Additional co-morbidities:
1. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to screening visit.
2. Active AIDS-defining disease other than oesophageal candidiasis.
3. Any active life- threatening disease
4. Active malignancy (except for early dysplastic lesions eg anal dysplasia)
5. Congestive cardiac failure
6. Platelet count < 100x103 cells/mm3 and/or INR > 1.4
7. Severe renal impairment with CrCl< 30mL/min

Lifestyle:
Excessive alcohol consumption during the last 6 months prior inclusion defined by more than 14 units/week for women or 21 units/week for men

Concomitant medications:
1. Patients actively treated with Maraviroc or having received Maraviroc over the last 12 months.
2. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study.
3. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents or immunomodulating agents.
4. Receiving any experimental medications within 30 days prior to screening or anticipated use during the trial.
5. Patients receiving pioglitazone, rosiglitazone, vitamin E 800 IU/day, , and/or ursodeoxycholic acid since these drugs may have confounding effect on efficacy of MVC

Others
1. Females who are pregnant or breastfeeding
2. Allergy to the study drug or its components (including peanut and soya)
3. Participation in any other clinical trial at Screening without approval from the Sponsor

Study & Design

• Study Type: Interventional
• Study Design: Not specified