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    Clinical Trial Results:
    A Phase II, Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of Triple Therapy with Dolutegravir plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

    Summary
    EudraCT number
    		 2016-000346-61
    Trial protocol
    		 PT  
    Global end of trial date
    02 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2021
    First version publication date
    23 Jul 2021
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    DTG-01-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BlueClinical, Ltd.
    Sponsor organisation address
    Av. Villagarcia de Arosa, 1919 - 1º, Matosinhos, Portugal, 4460-439
    Public contact
    Clinical Trials Information, Blueclinical, Ltd., 00351 220 995 159, regulatory@blueclinical.pt
    Scientific contact
    Clinical Trials Information, Blueclinical, Ltd., 00351 220 995 159, regulatory@blueclinical.pt
    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
    23 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] in the treatment of HIV-2 treatment-naïve subjects, as measured by the proportion of subjects achieving a plasma viral load of <40 copies/mL and/or by the change from baseline in CD4 cell count and in CD4/CD8 ratio at Week 48.
    Protection of trial subjects
    Inclusion and exclusion criteria
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2017
    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
    Portugal: 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)
    28
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were selected from the Institution where the Site belongs.

    Pre-assignment
    Screening details
    		 At the Screening visit, ICF was discussed and obtained from the subject, prior to the performance of any study-related procedure. The screening period was of 45 days (from Day - 45 to Day 0).

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

    Arms
    Arm title
    		 Dolutegravir
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing schedule: One tablet, once daily Route/mode of administration: Orally, without regard of food

    Number of subjects in period 1
    		Dolutegravir
    Started
    30
    Completed
    27
    Not completed
    3
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dolutegravir
    Reporting group description
    		 -

    Reporting group values
    		 Dolutegravir Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 28 28
        From 65-84 years
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Dolutegravir
    Reporting group description
    		 -

    Primary: Overall treatment succes

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    End point title
    		 Overall treatment succes [1]
    End point description
    End point type
    Primary
    End point timeframe
    Global Success at 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: The overall treatment success defined as the proportion of patients with “global success”: n/N, in wich n= number of Subjects that Achieved Success; and N=Total Number of Subjects with Evaluable Data
    End point values
    		 Dolutegravir
    Number of subjects analysed
    27
    Units: number of subjects
        number (confidence interval 95%)
    55.56 (36.81 to 72.88)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    17MAY2017 to 02JUL2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 30 (80.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    4
    Hypertensive crisis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Surgical and medical procedures
    Knee operation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vulvovaginal erythema
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Nasal obstruction
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    5
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Mean cell volume increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Weight increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Fracture
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Anaemia postoperative
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    7 / 30 (23.33%)
         occurrences all number
    7
    Memory impairment
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    3
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    6
    Chronic gastritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    4
    Flatulence
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Rectal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Neck pain
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Tendonitis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Infections and infestations
    Body tinea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Periodontitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Strongyloidiasis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Tracheobronchitis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Latent tuberculosis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2018
    Protocol version 4.0 created after a “Dear Investigator Letter”

    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.

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