Adding MAraViroc &/or METformin for Hepatic Steatosis in People Living With HIV

• Status: Completed
• Trial end date: 2020-11-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre, phase IV, randomised, open-label, trial exploring adjunctive maraviroc and/or metformin for liver steatosis over 48 weeks.

Sponsored by University College London Coordinated by MRC Clinical Trials Unit at UCL

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MRC [ycm]; University College, London
• Collaborators: Medical Research Council; Royal Free Hospital NHS Foundation Trust; ViiV Healthcare
• Treatments: Maraviroc; Metformin

Criteria

PATIENT INCLUSION CRITERIA

1. Signed informed consent

2. Males or females ≥35 years of age

3. Chronic HIV-1-infection for ≥5 years

4. On combination antiretroviral therapy (cART) and with virological suppression (<50 copies/mL) for ≥1 year

5. i) >1 abnormal (above the upper limit) of LFTS (ALT or AST) in the last 2 years with no other explanation (e.g. secondary syphilis) and/or ii) increased waist circumference ≥94 cm (≥90cm if South Asian origin) in men, ≥80cm in women and/or iii) a confirmed diagnosis of NAFLD on liver imaging (CT/MRI/ultrasound), FibroScan and/or iv) liver biopsy confirmed diagnosis of NALFD

6. Females of child bearing potential (CBP) who agree to avoid pregnancy for the duration of the trial

7. Able to comply with protocol requirements

PATIENT EXCLUSION CRITERIA

1. Co-infection with hepatitis B or C

2. Confirmed chronic liver disease from any other cause (e.g. hepatitis C, hepatitis B)

3. Daily intake of alcohol >20g in women and >30g in men

4. Current illicit drug use that in the opinion of the investigator would interfere with patient's ability to comply with the protocol

5. On metformin or another biguanide agent;

6. Currently on maraviroc

7. Any contraindication to the receipt of maraviroc and/or metformin

8. Known B12 deficiency

9. Pregnant or breast feeding

10. Contraindication to MRI scanning

11. Peanut or soya allergy

12. eGFR <60 ml/min/1.73m2

13. ALT ≥10 x ULN

14. History of cardiovascular (ischaemic heart disease) or cerebrovascular disease.

15. Any other condition that in the opinion of the investigator would not make the patient suitable for the trial.