Clinical Trial Results:
A randomised, open label, prospective study to assess two different therapeutic strategies following first treatment failure in HIV-1 infected subjects.
‘The First Failure Study’ : ‘FAST’
Summary
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EudraCT number |
2009-011816-39 |
Trial protocol |
GB |
Global end of trial date |
28 Apr 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Dec 2019
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First version publication date |
28 Dec 2019
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Other versions |
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Summary report(s) |
Prematurely Ended |
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 |
13SM1317
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Additional study identifiers
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ISRCTN number |
- | ||
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 |
South Kensington Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Alan Winston-OKeefe, Imperial College London, a.winston@imperial.ac.uk
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Scientific contact |
Alan Winston-OKeefe, Imperial College London, 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 |
28 Apr 2014
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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 |
28 Apr 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences between two such treatment approaches include differences in body fat distribution, in blood fat levels, in adherence and in neurocognitive function.
The primary objective is to measure the changes from baseline in peripheral and central body fat, as measured by DEXA scan at weeks 48 and 96 between the treatment arms.
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2010
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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: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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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 |
This trial was prematurely ended due to failure to recruit participants. 99999 is "Not applicable" value or 0 participants. | ||||||
Pre-assignment
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Screening details |
N/A | ||||||
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 |
N/A
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Arms
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Arm title
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4 active comparator drugs and a placebo | ||||||
Arm description |
- | ||||||
Arm type |
Trial ended prematurely | ||||||
Investigational medicinal product name |
Trial ended prematurely
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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 |
N/A
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
4 active comparator drugs and a placebo
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Reporting group description |
- |
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End point title |
Mean change from baseline in peripheral and central adipose tissue, as measured by DEXA, at weeks 48 and 96 between treatment arms [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
N/A
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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 trial ended prematurely due to insufficient recruitment numbers so statistical analysis was done. |
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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 |
N/A
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
4 active comparator drugs and a placebo
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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: The trial ended prematurely due to insufficient recruitment numbers so no adverse events occurred. |
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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. | |||
The trial ended prematurely due to insufficient recruitment. 99999 is "Not applicable" value or 0 participants. |