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   43857   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:
    Evaluation of the efficacy and tolerability of long-term administration of Acetyl-L-Carnitine in the treatment of HIV related lipodystrophy. Parallel-group, randomized, double blind, placebo-controlled study.

    Summary
    EudraCT number
    		 2005-004665-42
    Trial protocol
    		 IT  
    Global end of trial date
    20 Jan 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Nov 2020
    First version publication date
    05 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ST 200 DS 05-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sigma Tau
    Sponsor organisation address
    Viale Shakespeare 47, Rome, Italy,
    Public contact
    Serena Principe, Alfasigma, serena.principe@alfasigma.com
    Scientific contact
    Serena Principe, Alfasigma, serena.principe@alfasigma.com
    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
    07 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is the evaluation of the efficacy and tolerability of Acetyl-L-Carnitine administered at the dose of 3 g/die for 48 weeks in patients affected by HIV related lipodystrophy. The primary objective consists in the variation of the following parameters: • Homeostasis Model of Assessment (HOMA), i.e. the evaluation of the ratio between glycemia and insulinemia. • Mitochondrial DNA content of CD4 and CD8 cells.
    Protection of trial subjects
    The study was performed in accordance with the Declaration of Helsinki, GCP guidelines and applicable normative dispositions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 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
    Italy: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of a screening period of up to 4 weeks.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acetyl-L-Carnitine arm
    Arm description
    		 Patients randomized to this arm of the study were treated with Acetyl-L-Carnitine granules for oral solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acetyl-L-Carnitine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Patients randomized to this arm of the study were treated with Acetyl-L-Carnitine granules for oral solution administered orally in one 1 g sachet tris in die (after breakfast, after lunch and after dinner) for 48 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Patients randomized to this arm of the study were treated with placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Patients randomized to this arm of the study were treated with Placebo granules for oral solution administered orally in one sachet tris in die (after breakfast, after lunch and after dinner) for 48 weeks.

    Number of subjects in period 1
    		Acetyl-L-Carnitine arm Placebo
    Started
    20
    20
    Completed
    15
    14
    Not completed
    5
    6
         Drop out
    5
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Acetyl-L-Carnitine arm
    Reporting group description
    		 Patients randomized to this arm of the study were treated with Acetyl-L-Carnitine granules for oral solution.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to this arm of the study were treated with placebo.

    Reporting group values
    		 Acetyl-L-Carnitine arm Placebo Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20 40
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 6.4 ) 46 ( 5.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 2 6
        Male
    		 16 18 34

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Acetyl-L-Carnitine arm
    Reporting group description
    		 Patients randomized to this arm of the study were treated with Acetyl-L-Carnitine granules for oral solution.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to this arm of the study were treated with placebo.

    Subject analysis set title
    Per protocol Acetyl-L-Carnitine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population includes all patients who completed the study. The PP Population is the primary population for the efficacy analysis

    Subject analysis set title
    Per Protocol Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population includes all patients who completed the study. The PP Population is the primary population for the efficacy analysis.

    Primary: Homeostasis Model of Assessment (HOMA) variation

    		 Close Top of page
    End point title
    		 Homeostasis Model of Assessment (HOMA) variation
    End point description
    HOMA absolute change at visit 4 (after 48 ± 2 weeks of treatment) vs visit 1 (baseline).
    End point type
    Primary
    End point timeframe
    46-54 weeks.
    End point values
    		 Per protocol Acetyl-L-Carnitine Per Protocol Placebo
    Number of subjects analysed
    15
    14
    Units: HOMA absolute change
        arithmetic mean (standard deviation)
    -0.19 ( 1.52 )
    1.25 ( 9.51 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per protocol Acetyl-L-Carnitine v Per Protocol Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 Welch two sample t-test
    Confidence interval

    Primary: CD4 mitochondrial DNA content variation

    		 Close Top of page
    End point title
    		 CD4 mitochondrial DNA content variation
    End point description
    End point type
    Primary
    End point timeframe
    46-50 weeks
    End point values
    		 Per protocol Acetyl-L-Carnitine Per Protocol Placebo
    Number of subjects analysed
    15
    14
    Units: CD4 mit. DNA content absolute change
        arithmetic mean (standard deviation)
    -26.9 ( 93.6 )
    8.2 ( 91.8 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per protocol Acetyl-L-Carnitine v Per Protocol Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Welch two sample t-test
    Confidence interval

    Primary: CD8 mitochondrial DNA content variation

    		 Close Top of page
    End point title
    		 CD8 mitochondrial DNA content variation
    End point description
    End point type
    Primary
    End point timeframe
    46-50 weeks
    End point values
    		 Per protocol Acetyl-L-Carnitine Per Protocol Placebo
    Number of subjects analysed
    15
    14
    Units: CD8 mit. DNA content absolute change
        arithmetic mean (standard deviation)
    -37.1 ( 81.6 )
    -40.8 ( 160.5 )
    Statistical analysis title
    		 Efficacy statistical analysis
    Comparison groups
    Per protocol Acetyl-L-Carnitine v Per Protocol Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Welch two sample t-test
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    46-50 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ND
    Dictionary version
    ND
    Reporting groups
    Reporting group title
    ITT population
    Reporting group description
    		 -

    Serious adverse events
    		 ITT population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 40 (7.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute hepatitis C
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    		 ITT population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 40 (75.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid cyst
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Sinusitis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Bundle branch block right
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Aortic dilatation
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hyperamylasaemia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Proteinuria
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Leukocyturia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    6
    Oropharyngeal pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Osteoporosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Osteopenia
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    Penile wart
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperinsulinaemia
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Diabetes mellitus
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Dyslipidaemia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Insulin resistance
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hypovitaminosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2006
    Changes in some administrative informations
    14 Jul 2008
    Change of the CRO

    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 04:28:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA