Clinical Trial Results:
Maraviroc Add-on Therapy for Steatohepatitis in HIV
Summary
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EudraCT number |
2017-003172-32 |
Trial protocol |
DE GB |
Global end of trial date |
01 Mar 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Nov 2022
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First version publication date |
03 Nov 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MASHVs1.118-08-17
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Additional study identifiers
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ISRCTN number |
ISRCTN15410818 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
Exhibition Rd, London, United Kingdom,
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Public contact |
James Maurice, Imperial College London, james.maurice@imperial.ac.uk
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Scientific contact |
James Maurice, Imperial College London, james.maurice@imperial.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Mar 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Mar 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Mar 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Does maraviroc change the inflammatory cell infiltrate in the livers of patients with HIV infection and non-alcoholic steatohepatitis?
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Dec 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 7
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Country: Number of subjects enrolled |
Germany: 7
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Worldwide total number of subjects |
14
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Adult patients between the age of 18 and 75 and history of HIV-1 mono-infection with histological evidence of NASH, based on liver histology performed within 12 months before visit HIV infection treated and controlled | ||||||
Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
NA
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Arms
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Arm title
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Single arm | ||||||
Arm description |
Add on Maraviroc: patients received 150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions | ||||||
Arm type |
proof of concept study | ||||||
Investigational medicinal product name |
Maraviroc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions
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Period 2
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Period 2 title |
Endline
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Is this the baseline period? |
No | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A
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Arms
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Arm title
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Single arm | ||||||
Arm description |
Add on Maraviroc: patients received 150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions | ||||||
Arm type |
proof of concept study | ||||||
Investigational medicinal product name |
Maraviroc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Single arm
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Reporting group description |
Add on Maraviroc: patients received 150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions | ||
Reporting group title |
Single arm
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Reporting group description |
Add on Maraviroc: patients received 150mg, 300mg, or 600mg of Maraviroc taken twice daily for 48 weeks as add-on therapy with the dosing adjusted for any drug interactions | ||
Subject analysis set title |
primary endpoint
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
the change in hepatic immune cell and inflammatory infiltrate of the HIV-NASH patients to determine the efficacy of Maraviroc in treating such cases.
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End point title |
primary endpoint [1] | ||||||||
End point description |
the change in hepatic immune cell and inflammatory infiltrate of the HIV-NASH patients
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End point type |
Primary
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End point timeframe |
48 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: the change in hepatic immune cell and inflammatory infiltrate of the HIV-NASH patients to determine the efficacy of Maraviroc in treating such cases using paired liver biopsy The endpoint has not been reached since no statistical difference was observed after treatment with Maraviroc compared to baseline liver histology |
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Notes [2] - one patient did not get the second liver biopsy |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
48 weeks
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
1.0
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Reporting groups
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Reporting group title |
study participants
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: None |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |