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    Clinical Trial Results:
    PRotease-Inhibitors MOnotherapy Strategies as maintenance therapy in persons with fully suppressed HIV replication: results from an open-label randomized comparative trial (PRIMO Trial)

    Summary
    EudraCT number
    		 2009-016697-32
    Trial protocol
    		 IT  
    Global end of trial date
    10 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2019
    First version publication date
    27 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INMI/001/09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    National Institute for Infectious Diseases Lazzaro Spallanzani
    Sponsor organisation address
    Via Portuense 292, Rome, Italy, 00149
    Public contact
    Andrea Antinori, National Institute for Infectious Diseases Lazzaro Spallanzani, +39 0655170546, immunodeficienzevirali@inmi.it
    Scientific contact
    Andrea Antinori, National Institute for Infectious Diseases Lazzaro Spallanzani, +39 0655170546, immunodeficienzevirali@inmi.it
    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
    10 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the trial was to compare the efficacy of different maintenance strategies based on PI/r monotherapy (LPV/r or DRV/RTV) in HIV-1 infected persons with fully suppressive PI/r based therapy.
    Protection of trial subjects
    Exclusion of pregnant or breastfeeding woman
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    108
    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)
    102
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 122 [1]
    Number of subjects completed
    		 108

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 4
    Reason: Number of subjects
    		 Physician decision: 10
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period included 14 subjects who were screening failure and were not included inthe worldwide number enrolled in the trial.
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM B
    Arm description
    		 subjects switched to monotherapy based on LPV/r 800/200 mg QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    monotherapy based on LPV/r 800/200 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ARM B: Lopinavir/ritonavir 800/200 mg QD

    Arm title
    		 ARM C
    Arm description
    		 subjects switched to monotherapy based on DRV/r 800/100 mg QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRV/r 800/100 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects switched to monotherapy based on DRV/r 800/100 mg QD

    Arm title
    		 ARM A
    Arm description
    		 ARM A: standard of care, participants continued triple therapy based on 2NRTI+1 boosted PI
    Arm type
    		 Active comparator

    Investigational medicinal product name
    2NRTI+1 boosted PI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ARM A: standard of care, participants continued triple therapy based on 2NRTI+1 boosted PI

    Number of subjects in period 1
    		ARM B ARM C ARM A
    Started
    35
    38
    35
    Completed
    17
    29
    24
    Not completed
    18
    9
    11
         Consent withdrawn by subject
    3
    1
    6
         Physician decision
    2
    -
    2
         Adverse event, non-fatal
    5
    1
    1
         Pregnancy
    1
    1
    -
         Lost to follow-up
    -
    2
    2
         Lack of efficacy
    7
    4
    -

    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
    		 108 108
    Age categorical
    Age at enrolement is calculated in years as the difference between the birth date and the screening date
    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)
    		 102 102
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 45 (36 to 50) -
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 79 79

    End points

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    End points reporting groups
    Reporting group title
    ARM B
    Reporting group description
    		 subjects switched to monotherapy based on LPV/r 800/200 mg QD

    Reporting group title
    ARM C
    Reporting group description
    		 subjects switched to monotherapy based on DRV/r 800/100 mg QD

    Reporting group title
    ARM A
    Reporting group description
    		 ARM A: standard of care, participants continued triple therapy based on 2NRTI+1 boosted PI

    Subject analysis set title
    Analisys B vs A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population included all participants who were randomized and who have token at least one dose of study medication

    Subject analysis set title
    Analisys C vs A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population included all participants who were randomized and who have token at least one dose of study medication

    Primary: -Difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group B vs group A

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    End point title
    		 -Difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group B vs group A [1]
    End point description
    The end point is the difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group B vs. group A
    End point type
    Primary
    End point timeframe
    week 48
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: the groups of subjects applicable to this end point are only group B and group A
    End point values
    		 ARM B ARM A Analisys B vs A
    Number of subjects analysed
    35
    35
    66
    Units: 40
    17
    23
    40
    Statistical analysis title
    		 non-inferiority design
    Statistical analysis description
    The end point is the difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group B vs. group A
    Comparison groups
    ARM B v ARM A
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 ≤ 0.025 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [2] - This analysis aims to test non-inferiority of arm B (LPV/r) versus arm A (triple regimen), with a non-inferiority margin of 12%, with one-sided significance level of p=0.025 and 80% power.
    [3] - none comment

    Primary: -Difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group C vs group A

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    End point title
    		 -Difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group C vs group A [4]
    End point description
    The end point is the difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group C vs. group A
    End point type
    Primary
    End point timeframe
    week 48
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: the groups of subjects applicable to this end point are only group C and group A
    End point values
    		 ARM C ARM A Analisys C vs A
    Number of subjects analysed
    38
    35
    71
    Units: 27
    27
    23
    50
    Statistical analysis title
    		 non-inferiority design
    Statistical analysis description
    The end point is the difference in percentage of subjects with a plasma HIV-RNA <50 cp/mL at week 48 of group C vs. group A
    Comparison groups
    ARM A v ARM C
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 ≤ 0.025 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [5] - This analysis aims to test non-inferiority of arm C (DRV/r) versus arm A (triple regimen), with a non-inferiority margin of 12%, with one-sided significance level of p=0.025 and 80% power
    [6] - none comment

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to week 96
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Serious adverse events
    		 overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 103 (3.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    Additional description: None additional description
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture
    Additional description: None additional description
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Necrosis
    Additional description: femoral head necrosis
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Febrile infection
    Additional description: None additional description
         subjects affected / exposed
    1 / 103 (0.97%)
         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
    		 overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 103 (30.10%)
    Cardiac disorders
    pain
    Additional description: praecordial pain and dyspnoea on exertion
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Immune system disorders
    Rhinitis allergic
    Additional description: allergic rhinoconjunctivitis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    reaction to ketoprofen
    Additional description: cough, edema and eyelid erythema, itching of the trunk after taking Oki
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    5 / 103 (4.85%)
         occurrences all number
    5
    Pain
    Additional description: anal pain, pubic pain and fever
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Gastroenteritis
    Additional description: gastroenteritis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Pregnancy
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pharyngitis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Bronchospasm
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    folliculitis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Impetigo
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Wound
    Additional description: lesion with secretion to left foot plant
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Onychomycosis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Anal fissure
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Fracture
    Additional description: fibula and tibia fracture and patella right leg fracture
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Umbilical hernia
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Back pain
    Additional description: low back pain
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Head injury
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Infections and infestations
    Anorectal infection
    Additional description: anal condyloma wih high grade SIL
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Herpes zoster
    Additional description: one patient had mono dermatomeric herpes zooster and one patient had Thoracodorsal herpes zooster
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    2 / 103 (1.94%)
         occurrences all number
    2
    Varicella
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    2 / 103 (1.94%)
         occurrences all number
    2
    Viral skin infection
    Additional description: plantar wart
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    diabetes
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Hyperamylasaemia
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1
    Hyperlipidaemia
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 103 (0.97%)
         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
    21 Apr 2011
    PI substitution
    10 Mar 2012
    PI substitution
    20 Mar 2012
    PI substitution

    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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