Clinical Trial Results:
Pharmacokinetic interactions between silymarin and Darunavir/Ritonavir
Summary
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EudraCT number |
2010-021159-25 |
Trial protocol |
ES |
Global end of trial date |
20 Jul 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2018
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First version publication date |
05 Jan 2018
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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 |
SILIDAR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01346982 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundació Lluita contra la SIDA
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Sponsor organisation address |
Crta de Canyet s/n, Badalona, Spain, 08916
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Public contact |
CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14, sgel@flsida.org
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Scientific contact |
CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14,
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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 |
20 Jul 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jul 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jul 2011
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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 evaluate the potential of silymarin to interact with a boosted protease inhibitor such as darunavir-ritonavir and to evaluate the risk associated of its joint intake in HIV-Infected patients.
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Protection of trial subjects |
not specific
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Mar 2011
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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 |
Spain: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
15
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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 |
A total of 15 Caucasian HIV-infected males were enrolled. | ||||||
Pre-assignment
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Screening details |
All patients receiving antiretroviral therapy with darunavir-ritonavir (600/100 mg twice daily) for at least 4 weeks were enrolled. | ||||||
Period 1
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Period 1 title |
overall (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Experimental arm | ||||||
Arm description |
darunavir-ritonavir plus one capsule containing 150 mg of silymarin | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Darunavir/ritonavir (DRV/r)
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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 |
600/100 mg twice daily
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Investigational medicinal product name |
silymarin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
150 mg of silymarin every 8 h from days 1 to 14
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Baseline characteristics reporting groups
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Reporting group title |
overall
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental arm
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Reporting group description |
darunavir-ritonavir plus one capsule containing 150 mg of silymarin |
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End point title |
darunavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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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: one single arm study |
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No statistical analyses for this end point |
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End point title |
darunavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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Notes [2] - 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: one single arm study |
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No statistical analyses for this end point |
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End point title |
darunavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [3] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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Notes [3] - 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: one single arm study |
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No statistical analyses for this end point |
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End point title |
ritonavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [4] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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Notes [4] - 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: one single arm study |
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No statistical analyses for this end point |
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End point title |
ritonavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [5] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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Notes [5] - 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: one single arm study |
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No statistical analyses for this end point |
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End point title |
ritonavir pharmacokinetic parameters with and without coadministration of multiple doses of silymarin [6] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 12
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Notes [6] - 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: one single arm study |
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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 |
week 12
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Assessment type |
Non-systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
DAIDS AE GRADING TAB | ||||||||||||||
Dictionary version |
1.0
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Reporting groups
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Reporting group title |
experimental group
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||
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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 |