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    Clinical Trial Results:
    The Safety and Efficacy of The Histone Deacetylase Inhibitor Panobinostat for Purging HIV-1 from The Latent Reservoir (CLEAR) Study

    Summary
    EudraCT number
    		 2012-000240-94
    Trial protocol
    		 DK  
    Global end of trial date
    16 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2021
    First version publication date
    27 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLEAR0001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus, Denmark, 8200
    Public contact
    Department of Infectious Diseases, Aarhus University Hospital, 0045 78452841, thomrasm@rm.dk
    Scientific contact
    Department of Infectious Diseases, Aarhus University Hospital, 0045 78452841, thomrasm@rm.dk
    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
    15 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To re-activate HIV transcription in latently infected CD4+ T-cells as measured by an increase >0.5 log10 from baseline in copies of unspliced HIV-RNA/μg total RNA in the CD4+ T-cells of HIV-infected patients on suppressive HAART
    Protection of trial subjects
    Frequent clinical and lab test monitoring; strategy for dose-reduction; exclusion of participants with conditions believed to enhance risks of participation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    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
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Written information and advertisements approved by The Research Ethics Committee and Investigator databases may be used for recruitment purposes. Eligible study subjects will receive written invitation to participate in the study unless the subject has asked not be contacted in such matters.

    Pre-assignment
    Screening details
    		 5.1 Inclusion Criteria • Documented HIV-1 infection • Age >18 years • HIV-1 plasma RNA <50 copies/ml for at least 2 years with at least 2 viral load measures per year. Episodes of a single HIV plasma RNA 50-199 copies/ml will not exclude participation if the subsequent HIV plasma RNA was <50 copies/ml • Receiving HAART, defined as at least 2 nu

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Number of subjects completed
    		 15

    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
    		 Intervention arm (single-arm study)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Panobinostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg 3 times per week every other week

    Number of subjects in period 1
    		Intervention arm (single-arm study)
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 47 (28 to 53) -
    Gender categorical
    Units: Subjects
        Male
    		 15 15
        Female
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Pre-therapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Before starting Panobinostat

    Subject analysis sets values
    		 Pre-therapy
    Number of subjects
    15
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    15
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    47 (28 to 53)
    Gender categorical
    Units: Subjects
        Male
    15
        Female
    0

    End points

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    End points reporting groups
    Reporting group title
    Intervention arm (single-arm study)
    Reporting group description
    		 -

    Subject analysis set title
    Pre-therapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Before starting Panobinostat

    Primary: Cell-associated HIV RNA

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    End point title
    		 Cell-associated HIV RNA
    End point description
    End point type
    Primary
    End point timeframe
    During 8 weeks of study therapy
    End point values
    		 Intervention arm (single-arm study) Pre-therapy
    Number of subjects analysed
    15
    15
    Units: Maximum fold-change from baseline
        geometric mean (full range (min-max))
    3.5 (2.1 to 14.4)
    1 (1 to 1)
    Statistical analysis title
    		 repeated measures anova
    Comparison groups
    Intervention arm (single-arm study) v Pre-therapy
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Fold-change from baseline
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Oct 2012 - Jan 2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 15 (93.33%)
    Cardiac disorders
    Palpitations
    Additional description: Cardiac assessment normal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nervous system disorders
    Post lumbar puncture headache
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    7
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    8
    Insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Immune system disorders
    Fever
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Polyp found during sigmoidoscopy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    stomach ache
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    sinusitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Fungal skin infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Psychiatric disorders
    Emotional stress
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Endocrine disorders
    Increased TSH
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hypoglycaemia
    Additional description: Postprandial
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Lower back ache after lumbar puncture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Fracture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    Influenza like illness
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Syphilis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

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    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
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    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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