Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    PILOT STUDY ASSESSING TREATMENT SIMPLIFICATION TO DARUNAVIR/RITONAVIR 900/100 mg ONCE DAILY GUIDED BY THE DARUNAVIR INHIBITORY QUOTIENT IN HEAVILY PRETREATED HIV-INFECTED PATIENT

    Summary
    EudraCT number
    		 2007-005979-34
    Trial protocol
    		 ES  
    Global end of trial date
    31 Jul 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2017
    First version publication date
    11 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DRV 900100 QD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00611039
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    Crta de Canyet s/n, Badalona, Spain, 08916
    Public contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14, rescrig@flsida.org
    Scientific contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14,
    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 Jul 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety to switch from darunavir / ritonavir 900/100 mg once daily in HIV-infected patients who maintain plasma HIV-1 RNA load <50 copies / mL while receiving darunavir / ritonavir 600/100 mg twice daily and who have a DRV vIQ equal to or greater than 2.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2008
    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
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 In this clinical trial 45 patients were screened

    Pre-assignment
    Screening details
    		 30 participants were finally enrolled

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QD group
    Arm description
    		 darunavir/ritonavir 900/100 mg qd
    Arm type
    		 Experimental

    Investigational medicinal product name
    darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules (900 mg) / 24 hours.

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet (100 mg) / 24 hours

    Arm title
    		 BID group
    Arm description
    		 darunavir/ritonavir 600/100 mg bid
    Arm type
    		 Active comparator

    Investigational medicinal product name
    darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules (600 mg) / 12 hours.

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet (100 mg) / 12 hours.

    Number of subjects in period 1
    		QD group BID group
    Started
    15
    15
    Completed
    13
    13
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    -
         persistent AE grade 2
    -
    1
         stroke with serious difficulty in swallowing pills
    -
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    QD group
    Reporting group description
    		 darunavir/ritonavir 900/100 mg qd

    Reporting group title
    BID group
    Reporting group description
    		 darunavir/ritonavir 600/100 mg bid

    Reporting group values
    		 QD group BID group Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 15 30
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 47 (39 to 59) 47 (40 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 4 1 5
        Male
    		 11 14 25

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    QD group
    Reporting group description
    		 darunavir/ritonavir 900/100 mg qd

    Reporting group title
    BID group
    Reporting group description
    		 darunavir/ritonavir 600/100 mg bid

    Primary: percentage of patients without therapeutic failure at week 48

    		 Close Top of page
    End point title
    		 percentage of patients without therapeutic failure at week 48 [1]
    End point description
    End point type
    Primary
    End point timeframe
    week 48
    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: No patient developed virologic failure during the follow-up. The proportion of patients without therapeutic failure at week 48 was 13/15 (86.7%) in both study groups together. Nothing to compare
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: percentage (%)
        number (not applicable)
    86.7
    86.7
    No statistical analyses for this end point

    Secondary: changes in the CD4+ T-cell count

    		 Close Top of page
    End point title
    		 changes in the CD4+ T-cell count
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: cells/mm3
    arithmetic mean (standard deviation)
        baseline
    546 ( 242 )
    439 ( 212 )
        week 48
    584 ( 310 )
    430 ( 119 )
    Statistical analysis title
    		 Comparing mean between groups at week 48
    Comparison groups
    BID group v QD group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.093
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Comparing mean between groups at baseline
    Comparison groups
    QD group v BID group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.206
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: changes in lipid profile: Total cholesterol

    		 Close Top of page
    End point title
    		 changes in lipid profile: Total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    179 ( 34 )
    185 ( 39 )
        week 48
    175 ( 34 )
    189 ( 27 )
    No statistical analyses for this end point

    Secondary: changes in lipid profile: HDL-cholesterol

    		 Close Top of page
    End point title
    		 changes in lipid profile: HDL-cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    40 ( 12 )
    44 ( 16 )
        week 48
    40 ( 12 )
    41 ( 13 )
    No statistical analyses for this end point

    Secondary: changes in lipid profile: LDL-cholesterol

    		 Close Top of page
    End point title
    		 changes in lipid profile: LDL-cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    101 ( 25 )
    98 ( 32 )
        week 48
    107 ( 29 )
    102 ( 22 )
    No statistical analyses for this end point

    Secondary: changes in lipid profile: Triglycerides

    		 Close Top of page
    End point title
    		 changes in lipid profile: Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    186 ( 101 )
    227 ( 202 )
        week 48
    164 ( 115 )
    238 ( 121 )
    No statistical analyses for this end point

    Secondary: changes in liver enzymes: AST

    		 Close Top of page
    End point title
    		 changes in liver enzymes: AST
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: IU/l
    median (inter-quartile range (Q1-Q3))
        baseline
    23 (18 to 31)
    25 (18 to 42)
        week 48
    25 (16 to 31)
    24 (21 to 25)
    No statistical analyses for this end point

    Secondary: changes in liver enzymes: ALT

    		 Close Top of page
    End point title
    		 changes in liver enzymes: ALT
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: IU/l
    median (inter-quartile range (Q1-Q3))
        baseline
    26 (16 to 38)
    28 (16 to 50)
        week 48
    23 (17 to 41)
    31 (19 to 88)
    No statistical analyses for this end point

    Secondary: increase ritonavir Ctrough

    		 Close Top of page
    End point title
    		 increase ritonavir Ctrough
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/l
    geometric mean (confidence interval 95%)
        week 48
    0.19 (0.1 to 0.36)
    1.11 (0.72 to 1.73)
    No statistical analyses for this end point

    Secondary: increase darunavir Ctrough

    		 Close Top of page
    End point title
    		 increase darunavir Ctrough
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: mg/l
        geometric mean (confidence interval 95%)
    0.52 (0.37 to 0.73)
    1.07 (0.79 to 1.45)
    No statistical analyses for this end point

    Secondary: patients who remained on the originally assigned dosage

    		 Close Top of page
    End point title
    		 patients who remained on the originally assigned dosage
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 QD group BID group
    Number of subjects analysed
    15
    15
    Units: percentage (%)
        number (not applicable)
    66.7
    86.7
    Statistical analysis title
    		 Comparing percentages
    Comparison groups
    QD group v BID group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.195
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    from baseline to week 48
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE GRADING TAB
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    QD group
    Reporting group description
    		 -

    Reporting group title
    BID group
    Reporting group description
    		 -

    Serious adverse events
    		 QD group BID group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 QD group BID group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    Vascular disorders
    stroke with serious difficulty in swallowing pills
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2008
    Subject withdrawal criteria redefined
    25 Mar 2008
    sample size modified
    16 Apr 2008
    treatment follow up changed from 24 to 48 weeks (protocol plus information sheet form modified)

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 17:48:32 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA