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   43861   clinical trials with a EudraCT protocol, of which   7284   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:
    One arm, Open label, Interventional, non-comparative Study to assess Changes in Lipids and Lipoproteins in HIV infected Women with Hyperlipidemia after Switch from boosted Protease Inhibitors to Raltegravir

    Summary
    EudraCT number
    		 2013-001564-37
    Trial protocol
    		 AT  
    Global end of trial date
    17 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    13 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AGMT_HIV1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02097108
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AGMT
    Sponsor organisation address
    Gentzgasse 60/20, Vienna, Austria, 1180
    Public contact
    Daniela Wolkersdorfer, AGMT, 0043 6626404411, d.wolkersdorfer@agmt.at
    Scientific contact
    Richard Greil, AGMT, 0043 5725525801, r.greil@salk.at
    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 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Objective: A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.
    Protection of trial subjects
    Patients will be assessed at baseline, after 4, 12 and 24 weeks. At each visit clinical data and blood samples will be collected. Safety will be monitored by reporting of clinical adverse events and laboratory abnormalities.
    Background therapy
    		 antiretroviral agents other than Protease inhibitor
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2013
    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
    Austria: 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

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 HIV infected women with hyperlipidemia receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months

    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
    		 Raltegravir
    Arm description
    		 Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Patients will be assessed at baseline, after 4, 12 and 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    ISENTRESS®
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg twice daily

    Number of subjects in period 1
    		Raltegravir
    Started
    11
    Completed
    9
    Not completed
    2
         Adverse event, non-fatal
    1
         patient was abroad for 6 months
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
    Gender categorical
    Units: Subjects
        Female
    		 11 11

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Raltegravir
    Reporting group description
    		 Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Patients will be assessed at baseline, after 4, 12 and 24 weeks.

    Primary: LDL cholesterol reduction

    		 Close Top of page
    End point title
    		 LDL cholesterol reduction [1]
    End point description
    A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.
    End point type
    Primary
    End point timeframe
    12 weeks
    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 statistical analyses is provided as this is an one arm, open label, non-comparative study. In summary, 10 out of 11 patients = 90.9% (95%CI 58.7% - 99.8%) reached the study goal to reduce their cholesterol levels. The null hypothesis of 35% can be rejected (p=0.0001).
    End point values
    		 Raltegravir
    Number of subjects analysed
    11
    Units: patients
    10
    No statistical analyses for this end point

    Secondary: changes from baseline in total cholesterol

    		 Close Top of page
    End point title
    		 changes from baseline in total cholesterol
    End point description
    To assess changes and from baseline in total cholesterol
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Raltegravir
    Number of subjects analysed
    11
    Units: mg/dl
    arithmetic mean (standard deviation)
        Baseline
    247.55 ( 21.07 )
        24 weeks
    215.7 ( 28.55 )
    No statistical analyses for this end point

    Secondary: changes from baseline in triglycerides

    		 Close Top of page
    End point title
    		 changes from baseline in triglycerides
    End point description
    To assess changes from baseline in triglycerides at endpoint
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Raltegravir
    Number of subjects analysed
    11
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    168.45 ( 57.08 )
        24 weeks
    83.3 ( 28.94 )
    No statistical analyses for this end point

    Secondary: changes from baseline HDL cholesterol

    		 Close Top of page
    End point title
    		 changes from baseline HDL cholesterol
    End point description
    To assess changes from baseline in HDL cholesterol at endpoint
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Raltegravir
    Number of subjects analysed
    11
    Units: mg/dl
    arithmetic mean (standard deviation)
        baseline
    58 ( 14.09 )
        24 weeks
    64 ( 12.75 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All (serious) adverse events occurring during study treatment were collected until 28 days after the end of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    Investigations
    GOT increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    GPT increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gamma GT increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Hair loss
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Renal and urinary disorders
    Pain during emiction
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    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-Thu Apr 25 15:29:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA