The MASH study

Phase 1

• Conditions: on alcoholic steatohepatitis (NASH) in patients with HIV mono-infection; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003172-32-DE
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-06
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 = 6 months from 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 enrollment with a
NAFLD activity score (NAS) = 4 with a score of at least 1 in each component (steatosis, lobular inflammation, and
hepatocyte ballooning)[19] and <10% weight loss since the time of liver biopsy
6. Consent to second liver biopsy after 48 weeks treatment with MVC.
7. Patient able to understand and signed a consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) 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.
2) 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
Full Set of Project Data IRAS Version 5.5.1
12
DRAFT4. 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
3) Lifestyle:
1. 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
4) 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
5) 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 Sponso

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified