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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    A PROSPECTIVE, RANDOMIZED, CONTROLLED AND PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SAQUINAVIR/RITONAVIR MONOTHERAPY vs HAART THERAPIES AS A NEW NUCLEOSIDE-SPARING MAINTENANCE STRATEGY.

    Summary
    EudraCT number
    		 2006-001136-47
    Trial protocol
    		 ES  
    Global end of trial date
    14 May 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SQV/RTV-MONOTERAPIA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00379405
    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, jtoro@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
    14 May 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of saquinavir/ritonavir monotherapy twice daily (as a nucleoside-sparing maintenance strategy), compare to HAART therapies.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 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
    Spain: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 28 patients were enrolled

    Pre-assignment
    Screening details
    		 Participants were randomized in a 2:1 ratio

    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
    		 SQV/r group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saquinavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg twice daily

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg twice daily

    Arm title
    		 control group
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		SQV/r group control group
    Started
    17
    11
    Completed
    13
    10
    Not completed
    4
    1
         Adverse event, non-fatal
    2
    -
         virological failure
    1
    -
         Lost to follow-up
    -
    1
         voluntary discontinuation of therapy
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    SQV/r group
    Reporting group description
    		 -

    Reporting group title
    control group
    Reporting group description
    		 -

    Reporting group values
    		 SQV/r group control group Total
    Number of subjects
    		 17 11 28
    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)
    		 17 11 28
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44 ± 8.13 42 ± 10.72 -
    Gender categorical
    Units: Subjects
        Female
    		 2 0 2
        Male
    		 15 11 26

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    SQV/r group
    Reporting group description
    		 -

    Reporting group title
    control group
    Reporting group description
    		 -

    Primary: patients who maintained virological suppression in plasma

    		 Close Top of page
    End point title
    		 patients who maintained virological suppression in plasma [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: Only 1 patient from the SQV/r group experienced virological failure at week 48. No need of comparison
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: percentage
        number (not applicable)
    96.4
    100
    No statistical analyses for this end point

    Secondary: changes in CD4+ T-cell counts

    		 Close Top of page
    End point title
    		 changes in CD4+ T-cell counts
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: cels/mm3
    number (not applicable)
        baseline
    838
    552
        week 48
    869
    604
    Statistical analysis title
    		 Comparing mean at baseline
    Comparison groups
    SQV/r group v control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.053
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: changes in HDL cholesterol

    		 Close Top of page
    End point title
    		 changes in HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: mg/dL
    number (not applicable)
        baseline
    41
    40
        week 48
    56
    46
    Statistical analysis title
    		 Comparing mean at week 48
    Comparison groups
    SQV/r group v control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.314
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: changes in total cholesterol

    		 Close Top of page
    End point title
    		 changes in total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: mg/dL
    number (not applicable)
        baseline
    200
    192
        week 48
    198
    187
    Statistical analysis title
    		 Comparing mean at week 48
    Comparison groups
    SQV/r group v control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.41
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: changes in LDL cholesterol

    		 Close Top of page
    End point title
    		 changes in LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: mg/dL
    number (not applicable)
        baseline
    127
    129
        week 48
    127
    107
    Statistical analysis title
    		 Comparing mean at week 48
    Comparison groups
    SQV/r group v control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.114
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: changes in triglycerides

    		 Close Top of page
    End point title
    		 changes in triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 SQV/r group control group
    Number of subjects analysed
    17
    11
    Units: mg/dL
    number (not applicable)
        baseline
    155
    144
        week 48
    116
    150
    Statistical analysis title
    		 Comparing mean at week 48
    Comparison groups
    SQV/r group v control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.376
    Method
    		 t-test, 2-sided
    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
    SQV/r group
    Reporting group description
    		 -

    Serious adverse events
    		 SQV/r group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Hepatobiliary disorders
    acute hepatitis B
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SQV/r group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    Hepatobiliary disorders
    2-fold increase in transaminase
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2006
    co-investigator added
    16 May 2006
    monitor changed
    26 Sep 2006
    exclusion criteria number 7 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 Apr 26 23:29:24 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA