Clinical Trial Results:
Efficacy of Lopinavir in Pregnancy: Pharmacokinetic and Virological Studies with Kaletra melt extruded tablet formulation
Summary
|
|
EudraCT number |
2007-000438-38 |
Trial protocol |
GB |
Global end of trial date |
28 Jul 2010
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
21 Sep 2019
|
First version publication date |
21 Sep 2019
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
CRO 682
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Imperial College London
|
||
Sponsor organisation address |
Norfolk Place, London, United Kingdom, W2 1PG
|
||
Public contact |
Graham Taylor, Imperial College London, +44 02075943910, g.p.taylor@imperial.ac.uk
|
||
Scientific contact |
Graham Taylor, Imperial College London, +44 02075943910, g.p.taylor@imperial.ac.uk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
31 Aug 2011
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
26 Jan 2010
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 Jul 2010
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To determine the plasma concentrations of lopinavir during pregnancy (when adminstered as a film coated tablet).
|
||
Protection of trial subjects |
No specific protection.
|
||
Background therapy |
General therapy | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jul 2006
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 11
|
||
Worldwide total number of subjects |
11
|
||
EEA total number of subjects |
11
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
11
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
Participant were recruited at St Mary Hospital between 01.06.2006-31.01.2010. | ||||||
Pre-assignment
|
|||||||
Screening details |
A total of 11 pregnant participant with HIV taking lopinavir enrolled to the study. | ||||||
Period 1
|
|||||||
Period 1 title |
Overall trial (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
All participant taking Lopinavir | ||||||
Arm description |
All participant taking Lopinavir 400mg twice a day (weeks 13 through pregnancy to 8 weeks postpartum) | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Lopinavir
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Tablet
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
400mg twice a day
|
||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
All participant taking Lopinavir
|
||
Reporting group description |
All participant taking Lopinavir 400mg twice a day (weeks 13 through pregnancy to 8 weeks postpartum) | ||
Subject analysis set title |
Trimester 1
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Measurement of the concentration at Trimester 1
|
||
Subject analysis set title |
Trimester 2
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Measurement of the concentration at Trimester 2
|
||
Subject analysis set title |
Trimester 3
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Measurement of the concentration at Trimester 3
|
||
Subject analysis set title |
Postpartum
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Measurement of the concentration at Postpartum
|
|
|||||||||||||||||||||
End point title |
Concentration of the Lopinavir in plasma | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Trimester 1, 2, 3, and postpartum
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Concentration differences in T1 vs. T3 | ||||||||||||||||||||
Comparison groups |
Trimester 1 v Trimester 3
|
||||||||||||||||||||
Number of subjects included in analysis |
14
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.008 | ||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
Statistical analysis title |
Concentration differences in T3 vs. postpartum | ||||||||||||||||||||
Comparison groups |
Trimester 3 v Postpartum
|
||||||||||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.004 | ||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||
Confidence interval |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
3 years
|
||||||||||
Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
10
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
Overall study
|
||||||||||
Reporting group description |
- | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
|
|||||||||||
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 adverse event recorded. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
|||
http://www.ncbi.nlm.nih.gov/pubmed/22106215 |