Clinical Trial Results:
A prospective, randomised study to assess safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters over 48 weeks in HIV-1 infected subjects undergoing a switch in antiretroviral therapy.
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Summary
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EudraCT number |
2009-011538-93 |
Trial protocol |
IE GB |
Global end of trial date |
29 Mar 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Nov 2019
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First version publication date |
01 Nov 2019
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Other versions |
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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 |
Maraviroc_switch
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00981773 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Prof Alan Winston, Imperial College London, +44 (0)20 3312 1603, a.winston@imperial.ac.uk
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Scientific contact |
Prof Alan Winston, Imperial College London, +44 (0)20 3312 1603, a.winston@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 |
29 Mar 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Mar 2013
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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 |
The aim of this study is to determine whether switching from an antiretroviral regimen containing abacavir and / or didanosine to one containing maraviroc will lead to a reduction in platelet reactivity at 12 and 24 weeks thereby conferring a reduction in risk of heart attack.
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2009
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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: 17
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Country: Number of subjects enrolled |
Ireland: 1
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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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) |
18
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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 |
Participants were enrolled between September 2011 and March 2013, from St Marys Hospital (London, UK) and Mater Misericordiae University Hospital (Dublin, Ireland). | |||||||||
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Pre-assignment
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Screening details |
The initial aim was to recruit 40 subjects, however of the 31 subjects on boosted protease inhibitor containing regimens who were screened, 18 had CCR5-tropic virus of whom 6 were randomised to immediate and 12 to deferred switch. | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Immediate switch | |||||||||
Arm description |
switch NRTI backbone to maraviroc 150 mg twice daily | |||||||||
Arm type |
Active comparator | |||||||||
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 |
150 mg twice daily
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Arm title
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Deferred switch | |||||||||
Arm description |
switch NRTI backbone to maraviroc 150 mg twice daily after `12 weeks | |||||||||
Arm type |
Active comparator | |||||||||
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 |
150 mg twice daily after 12 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Immediate switch
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Reporting group description |
switch NRTI backbone to maraviroc 150 mg twice daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Deferred switch
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Reporting group description |
switch NRTI backbone to maraviroc 150 mg twice daily after `12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
All participants
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Due to difficulties in recruitment (subjects were required to have CCR5 tropic HIV virus), lower numbers of participants than anticipated were recruited.
Analyses are therefore undertaken on the entire study population with no comparisons between study arms (before switch and after switch)
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End points reporting groups
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Reporting group title |
Immediate switch
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Reporting group description |
switch NRTI backbone to maraviroc 150 mg twice daily | ||
Reporting group title |
Deferred switch
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Reporting group description |
switch NRTI backbone to maraviroc 150 mg twice daily after `12 weeks | ||
Subject analysis set title |
All participants
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Due to difficulties in recruitment (subjects were required to have CCR5 tropic HIV virus), lower numbers of participants than anticipated were recruited.
Analyses are therefore undertaken on the entire study population with no comparisons between study arms (before switch and after switch)
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End point title |
Percentage changes in adenosine diphosphate (ADP) before and after switch [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 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: No statistical analyses due to the low number of participants. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Changes in D-dimer 12 weeks after switch | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12 weeks
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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 |
12 weeks
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Assessment type |
Non-systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
All 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: It was no non-serious adverse event |
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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 | |||
