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    Clinical Trial Results:
    Implication for strategies of long term control of viral replication in patient with primary HIV infection (PHI) treated with multitarget antiviral therapy (MT-ART)

    Summary
    EudraCT number
    		 2017-000554-19
    Trial protocol
    		 IT  
    Global end of trial date
    11 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2022
    First version publication date
    27 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P25-INACTION
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04225325
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 P25-INACTION : P25-INACTION
    Sponsors
    Sponsor organisation name
    IRCCS Ospedale San Raffaele
    Sponsor organisation address
    Via Olgettina, 60, Milano, Italy, 20132
    Public contact
    Silvia Nozza, Department of Infectious Disease, 0039 0226437934, nozza.silvia@hsr.it
    Scientific contact
    Silvia Nozza, Department of Infectious Disease, 0039 0226437934, nozza.silvia@hsr.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 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to compare the virological efficacy of an intensive four-drug antiretroviral regimen against a standard regimen (chosen as the best one between an integrase-based or a protease inhibitor-based three drugs regimen) in HIV-1 subjects with Primary HIV Infection (PHI). In addition, we wish to evaluate changes in immunological and safety laboratory parameters, in viral reservoirs and to determine drugs concentrations in plasma, cerebrospinal fluid, lymph nodes and GALT
    Protection of trial subjects
    Approval by the local Ethics Committee was obtained before the beginning of the study and written informed consent was obtained from all patients at time of enrolment. Sponsor has stipulated an insurance to cover damages related to the study.
    Background therapy
    		 -
    Evidence for comparator
    		 Approved by Antiretroviral Therapy Guidelines
    Actual start date of recruitment
    03 May 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    78
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Multicenter, parallel group, randomised, open label, study involved 78 patients (between 18 and 65 years) with PHI never treated among those attending the outpatient Clinic of Infectious Diseases, Ospedale San Raffaele and other Italian centres, involved in the INACTION network. Patients were enrolled between 2018 and 2020.

    Pre-assignment
    Screening details
    		 Subjects with active opportunistic infection or malignancy, positive for Hepatitis B, with unstable liver disease or cirrhosis, with any clinically significant condition or situation that would interfere with the study evaluations or optimal participation, with allergy/sensitivity to drugs or its excipients were excluded

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM A (TAF/FTC+DRV/c)
    Arm description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (standard regimen)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TAF/FTC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/200 mg single tablet QD

    Investigational medicinal product name
    DRV/cobicistato
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg /150 mg single tablet QD

    Arm title
    		 ARM B (TAF/FTC+DTG)
    Arm description
    		 TAF/FTC 25 mg/200 mg single tablet QD + DTG 50 mg QD (standard regimen)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TAF/FTC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg/200 mg single tablet QD

    Investigational medicinal product name
    DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg QD

    Arm title
    		 ARM C (TAF/FTC+DRV/c+DTG)
    Arm description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV/cobicistat 800 mg /150 mg single tablet QD + DTG 50 mg QD (experimental regimen).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAF/FTC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/200 mg single tablet QD

    Investigational medicinal product name
    DRV/cobicistato
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg /150 mg single tablet QD

    Investigational medicinal product name
    DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg QD

    Number of subjects in period 1
    		ARM A (TAF/FTC+DRV/c) ARM B (TAF/FTC+DTG) ARM C (TAF/FTC+DRV/c+DTG)
    Started
    30
    28
    20
    Completed
    26
    27
    19
    Not completed
    4
    1
    1
         Consent withdrawn by subject
    4
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARM A (TAF/FTC+DRV/c)
    Reporting group description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (standard regimen)

    Reporting group title
    ARM B (TAF/FTC+DTG)
    Reporting group description
    		 TAF/FTC 25 mg/200 mg single tablet QD + DTG 50 mg QD (standard regimen)

    Reporting group title
    ARM C (TAF/FTC+DRV/c+DTG)
    Reporting group description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV/cobicistat 800 mg /150 mg single tablet QD + DTG 50 mg QD (experimental regimen).

    Reporting group values
    		 ARM A (TAF/FTC+DRV/c) ARM B (TAF/FTC+DTG) ARM C (TAF/FTC+DRV/c+DTG) Total
    Number of subjects
    		 30 28 20 78
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 30 28 20 78
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 0 1 4
        Male
    		 27 28 19 74

    End points

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    End points reporting groups
    Reporting group title
    ARM A (TAF/FTC+DRV/c)
    Reporting group description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (standard regimen)

    Reporting group title
    ARM B (TAF/FTC+DTG)
    Reporting group description
    		 TAF/FTC 25 mg/200 mg single tablet QD + DTG 50 mg QD (standard regimen)

    Reporting group title
    ARM C (TAF/FTC+DRV/c+DTG)
    Reporting group description
    		 TAF/FTC 10 mg/200 mg single tablet QD + DRV/cobicistat 800 mg /150 mg single tablet QD + DTG 50 mg QD (experimental regimen).

    Primary: HIV-DNA level

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    End point title
    		 HIV-DNA level
    End point description
    The primary end point is the change in total HIV-DNA level from baseline to 48 weeks. HIV-DNA change form baseline to W48 is 0.912 in ARMA A, 0.267 in ARM B and 0.988 in ARM C. No differences between Amrs. Multivariate analysis, change of HIV-DNA was significatly associated to CD4 increase an not to Treatment ARM, Age, Fiebig STage, CD4/CD8 Ratio or HIV-RNA.
    End point type
    Primary
    End point timeframe
    48 weeks post treatment
    End point values
    		 ARM A (TAF/FTC+DRV/c) ARM B (TAF/FTC+DTG) ARM C (TAF/FTC+DRV/c+DTG)
    Number of subjects analysed
    30
    28
    20
    Units: log10(copies/10^6PBMCs)
        log mean (inter-quartile range (Q1-Q3))
    3.79 (3.30 to 4.34)
    3.95 (3.46 to 4.36)
    4.09 (3.57 to 4.24)
    Statistical analysis title
    		 Treatment comparation
    Comparison groups
    ARM A (TAF/FTC+DRV/c) v ARM B (TAF/FTC+DTG) v ARM C (TAF/FTC+DRV/c+DTG)
    Number of subjects included in analysis
    78
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    48 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse event associated to IMPs were recorded.

    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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