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Hepatic SteatosisPhase 2/3MAVMETNCT03129113

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

A Phase 2/3 study testing Maraviroc and Metformin in people with Hepatic Steatosis and HIV-1-infection, run by University College, London at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Hepatic Steatosis, HIV-1-infection
What is being tested?
Maraviroc and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
6 sitesUnited Kingdom
Study dates
1 Mar 2017to 6 Nov 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • Royal London Hospital

    London, E1 1FR

  • Royal Free Hospital

    London, NW3 2QG

  • St Thomas' Hospital

    London, SE1 9RT

  • King's College Hospital

    London, SE5 9RJ

  • St Mary's Hospital

    London, W2 1NY

  • UCL Mortimer Market Centre

    London, WC1E 6JB

Other trials in United Kingdom

About this study

Official title: A Multicentre, 48 Week Randomised Controlled Factorial Trial of Adding Maraviroc and/or Metformin for Hepatic Steatosis in HIV-1-infected Adults on Combination Antiretroviral Therapy.

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

Read the detailed description

There is a global epidemic of obesity and/or being overweight. Fatty liver disease associated with overweight/obesity, can cause liver inflammation, which can lead to scarring of the liver (cirrhosis), liver cancer and early death. It is predicted that fatty liver disease will become the number one cause of liver cirrhosis in the next 20 years. There are no effective treatments, except weight loss, which is rarely successful.

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.

Being tested
Maraviroc, Metformin
Medical subject headings
Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaravirocDrug

    1:1:1:1 randomisation to one of four arms for 48 weeks

  • MetforminDrug

    1:1:1:1 randomisation to one of four arms for 48 weeks

Study groups in NCT03129113
Study groupRoleWhat they receive
maraviroc (Arm A)Experimentalmaraviroc dosed BID p/o (dose adjusted depending on background combination antiretroviral therapy).
Receives: Drug: Maraviroc
metformin (Arm B)Experimentalmetformin 500mg BID p/o.
Receives: Drug: Metformin
maraviroc + metformin (Arm C)Experimentalmaraviroc dosed BID p/o (dose adjusted depending on background combination antiretroviral therapy) PLUS metformin 500mg BID p/o.
Receives: Drug: Maraviroc; Drug: Metformin
no adjunctive therapy (Arm D)No interventionno adjunctive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percentage of liver fat as measured by MR PDFF between baseline and week 48.

    MR PDFF

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2017
  2. Study start1 Mar 2017
  3. Primary completion5 Nov 2020
  4. Study completion6 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2 by 2 factorial randomisation to one of the 4 arms.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03129113
Sponsor's protocol ID
MAVMET
Acronym
MAVMET
Status last verified
Nov 2021
First submitted
21 Apr 2017
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Maraviroc and Metformin in people with Hepatic Steatosis and HIV-1-infection, run by University College, London at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percentage of liver fat as measured by MR PDFF between baseline and week 48. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03129113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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