Clinical Trial Results:
Investigating the effect of Maraviroc on microbial translocation in HIV-1 infected individuals who are receiving antiretroviral therapy
Summary
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EudraCT number |
2010-023625-38 |
Trial protocol |
GB |
Global end of trial date |
01 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2019
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First version publication date |
09 Feb 2019
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
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 |
JF003
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Additional study identifiers
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ISRCTN number |
ISRCTN81045654 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 02071887188, julie.fox@kcl.ac.uk
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Scientific contact |
Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 02071887188, julie.fox@kcl.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 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2014
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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 |
To determine whether the addition of a CCR5 inhibitor to a stable ART regimen reduces microbial translocation (as determined by plasma bacterial 16s DNA)
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Protection of trial subjects |
Patients will be given information regarding which symptoms should alert them to the possibility of a serious adverse event following their biopsies, in particular perforation or bleeding,. In the event of these symptoms they will be advised to attend their local Accident & Emergency Department directly and to take with them their Patient Information Card and/or inform the medical staff that they are participating in a clinical trial and that the research unit needs to be informed of their admission.
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Background therapy |
Participants must be stable on antiretroviral therapy for at least 12 months. | ||
Evidence for comparator |
n/a | ||
Actual start date of recruitment |
01 May 2012
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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: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
10
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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 recruited from one clinical site in London during 2014. | ||||||
Pre-assignment
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Screening details |
Inclusion Criteria:- Males and females aged between 18-64 stable on antiretroviral therapy for at least 12 months. Screening CD4+ T cell count below 500 cells/mm.3 Screening plasma HIV RNA levels below 100 copies RNA/mL. Ability and willingness of subject to give provide informed consent. | ||||||
Period 1
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Period 1 title |
Whole Group (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Open label proof of concept trial.
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Arms
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Arm title
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Full study | ||||||
Arm description |
All participants as this is a single arm proof of concept trial. | ||||||
Arm type |
Pilot | ||||||
Investigational medicinal product name |
MARAVIROC
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Investigational medicinal product code |
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Other name |
CELCENTRI
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Maraviroc is marketed as CELSENTRI ® by ViiV Healthcare in film-coated tablets either 150mg or 300 mg in 60 tab pack. Maraviroc dose based on each participants current medications in regimen as per SmPC.
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Baseline characteristics reporting groups
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Reporting group title |
Whole Group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Full study
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Reporting group description |
All participants as this is a single arm proof of concept trial. |
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End point title |
Microbial Translocation [1] | ||||||
End point description |
Level of Microbial translocation as quantified by bacterial 16s DNA PCR at week 24
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End point type |
Primary
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End point timeframe |
Week 24 of participation.
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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: See attached document for all results data. |
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Attachments |
Results |
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No statistical analyses for this end point |
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End point title |
Secondary Endpoints | ||||||
End point description |
- Level of gut permeability: changes in level of CD14a
- Immune activation: changes in levels of CD8+CD38+
- Clinical outcome: CD4+ T cell count change and HIV plasma viral load change.
- Biomarkers of inflammation: levels of D-dimer
- Low copy HIV viral quantification
- Neurocognitive function: memory tests
- Gut immune reconstitution : Immunohistochemistry
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End point type |
Secondary
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End point timeframe |
Week 24 of Participation
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Duration of trial
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Whole Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
This is a proof of concept unpowered study involving 10 volunteers. The results of which will be used to provide information about the feasibility of conducting a large scale randomised control study. There is currently no pilot data on the effect of | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/27917639 |