Adding MAraViroc &/or METformin for Hepatic Steatosis in People Living With HIV
NCT ID: NCT03129113
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2017-03-01
2020-11-06
Brief Summary
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Sponsored by University College London Coordinated by MRC Clinical Trials Unit at UCL
Detailed Description
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In HIV-infected individuals, antiretroviral therapy (ART) is very successful at maintaining health long-term. However, despite this, data suggest that HIV-infected individuals are at greater risk of developing fatty liver disease than the general population, even if they are not overweight. Past exposure to some of the older, now obsolete, ART drugs, may have added to this greater risk. What makes things more difficult is that fatty liver disease can be 'silent' with no symptoms or signs until quite advanced.
MAVMET is trying to find out if maraviroc (licensed anti-HIV drug) and metformin (licensed for diabetes), given separately or in combination will reduce the amount of liver fat.
MAVMET participants are HIV-infected adult (aged at least 35), with HIV (but not hepatitis B/C) for 5 years or more, on combination ART for at least 1 year, and likely - because of abnormal liver tests and/or a large waist to have increased liver fat or already have a confirmed diagnosis of fatty liver disease, on a previous scan or a liver biopsy.
Participants will continue on their current ART and be randomised (like the flip of a coin) to receive 48 weeks of maraviroc (Arm A) or metformin (Arm B) or both drugs (Arm C) or no additional drugs (Arm D). Participants have 7 clinic visits over 48 weeks to monitor progress and 2 magnetic liver scans (MRI) (no radiation) at University College Hospital to measure liver fat. Mortimer Market Centre participants can also have optional brain MRI at the Institute of Neurology.
Patients can enrol at one of 3 sites: Mortimer Market Centre, St.Thomas's Hospital, King's College Hospital, London.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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maraviroc (Arm A)
maraviroc dosed BID p/o (dose adjusted depending on background combination antiretroviral therapy).
Maraviroc
1:1:1:1 randomisation to one of four arms for 48 weeks
metformin (Arm B)
metformin 500mg BID p/o.
Metformin
1:1:1:1 randomisation to one of four arms for 48 weeks
maraviroc + metformin (Arm C)
maraviroc dosed BID p/o (dose adjusted depending on background combination antiretroviral therapy) PLUS metformin 500mg BID p/o.
Maraviroc
1:1:1:1 randomisation to one of four arms for 48 weeks
Metformin
1:1:1:1 randomisation to one of four arms for 48 weeks
no adjunctive therapy (Arm D)
no adjunctive therapy
No interventions assigned to this group
Interventions
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Maraviroc
1:1:1:1 randomisation to one of four arms for 48 weeks
Metformin
1:1:1:1 randomisation to one of four arms for 48 weeks
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
35 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
ViiV Healthcare
INDUSTRY
Royal Free Hospital NHS Foundation Trust
OTHER
University College, London
OTHER
Responsible Party
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ADAM CURSLEY
Trial Manager
Principal Investigators
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Sarah Pett
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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Royal London Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
UCL Mortimer Market Centre
London, , United Kingdom
Countries
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Other Identifiers
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MAVMET
Identifier Type: -
Identifier Source: org_study_id