Clinical Trial Results:
A randomised prospective study assessing changes in neuro-cognitive function, using a computerised test battery, in treatment naïve HIV-1 positive subjects commencing two different antiretroviral regimens.
Summary
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EudraCT number |
2007-002405-47 |
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 |
16 Oct 2019
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First version publication date |
16 Oct 2019
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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 |
The CogNaive Study
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00540137 | ||
WHO universal trial number (UTN) |
- | ||
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 |
01 Oct 2015
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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 assess the changes in simple reaction time of study period as measured by a computerised test battery
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2008
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
20
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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 |
Participant were recruited at Imperial College Healthcare NHS Trust (St Mary’s Hospital, London, UK) and the Heart of England NHS Foundation Trust (Birmingham, UK) between February 2008 and October 2012. | ||||||||||||||||||
Pre-assignment
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Screening details |
24 subjects were screened, 20 were enrolled and 14 completed all study procedures. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (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-labelled
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Atazanavir | ||||||||||||||||||
Arm description |
emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily)+ atazanavir (300 mg once daily) | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Emtricitabine
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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 |
200mg daily
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Investigational medicinal product name |
Atazanavir
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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 |
300mg daily
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Investigational medicinal product name |
Tenofovir disoproxil fumarate
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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 |
245 mg once daily
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Investigational medicinal product name |
Ritonavir
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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 |
100mg daily
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Arm title
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Nevirapine | ||||||||||||||||||
Arm description |
Participants received emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily) plus nevirapine 400 mg (once daily). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Emtricitabine
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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 |
200mg daily
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Investigational medicinal product name |
Tenofovir disoproxil fumarate
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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 |
245 mg once daily
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Investigational medicinal product name |
Nevirapine
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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 |
400 mg once daily
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atazanavir
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Reporting group description |
emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily)+ atazanavir (300 mg once daily) | ||
Reporting group title |
Nevirapine
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Reporting group description |
Participants received emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily) plus nevirapine 400 mg (once daily). | ||
Subject analysis set title |
All participants_24weeks
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Given only 14 subjects completed our study, this analysis is descriptive with no formal comparisons across treatment arms, we merged the two arm from the beginning to one arm.
Results on 24weeks
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Subject analysis set title |
All participants_48weeks
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Given only 14 subjects completed our study, this analysis is descriptive with no formal comparisons across treatment arms, we merged the two arm from the beginning to one arm.
Results on 48weeks
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End point title |
Changes in Cognitive Function | ||||||||||||
End point description |
Cognitive scores were transformed using standardised z-scores according to the pooled baseline standard deviation, score increase means better cognitive function
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End point type |
Primary
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End point timeframe |
24 weeks, 48 weeks
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Statistical analysis title |
Cognitive Function | ||||||||||||
Comparison groups |
All participants_24weeks v All participants_48weeks
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.43 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
1 year
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Assessment type |
Non-systematic | |||||||||||||||
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 |
Atazanavir
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Reporting group description |
emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily)+ atazanavir (300 mg once daily) | |||||||||||||||
Reporting group title |
Nevirapine
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Reporting group description |
Participants received emtricitabine (200 mg once daily) + tenofovir disoproxil fumarate (245 mg once daily) plus nevirapine 400 mg (once daily). | |||||||||||||||
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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: No none serious adverse event on the study. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/27081393 |