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    Clinical Trial Results:
    Studio PKCT - Pharmacokinetics of chemotherapy when given concurrently with antiretroviral (Protocol no. CSL01).

    Summary
    EudraCT number
    		 2010-023749-30
    Trial protocol
    		 IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2020
    First version publication date
    06 Mar 2020
    Other versions
    Summary report(s)
    		 Poster

    Trial information

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    Trial identification
    Sponsor protocol code
    PKCTnrCSL01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ospedale San Raffaele Srl
    Sponsor organisation address
    Via Stamira d'Ancona 20, Milan, Italy, 20127
    Public contact
    Ospedale San Raffaele Srl, Ospedale San Raffaele Srl, 0039 0226437934, carini.elisabetta@hsr.it
    Scientific contact
    Ospedale San Raffaele Srl, Ospedale San Raffaele Srl, 0039 0226433473, castagna.antonella1@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
    Interim
    Date of interim/final analysis
    31 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    to study the pharmacokinetics of DX before and after the replacement of antiretroviral therapy that may alter the activity of the subunit CYP3A4 of the cytochrome p450 with raltegravir (drug that does not affect the activity of cytochrome p450).
    Protection of trial subjects
    Helsinky Declaration, CEE Regulations, GCP for trials on medical products in the European Coomunity, Italian ICH.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2011
    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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject with HIV infection and diagnosis of HL and NHL treated with ABVD abd R-CHOP respectively, doxorubicin PK on course of initial treatment with NNRTI or boosted PI and after switch to raltegravir including regimen.

    Pre-assignment
    Screening details
    		 Patients already on antiretroviral therapy and already being treated at our center, aged> 18 years and HD or NHL who require CT according to ABVD or (r) CHOP were enrolled.

    Period 1
    Period 1 title
    ABVD or CHOP treatment+cART ongoing
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ABVD or R-CHOP + ongoing cART
    Arm description
    		 -
    Arm type
    		 prospective evaluation

    Investigational medicinal product name
    ABVD or R-CHOP + ongoing cART
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABVD+EFV+TDF/FCT or R-CHOP+DRV/R+TDF/FCT or R-CHOP+LPV/R+3TC+DDI

    Number of subjects in period 1
    		ABVD or R-CHOP + ongoing cART
    Started
    3
    Completed
    3
    Period 2
    Period 2 title
    Raltegravir period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ABVD or R-CHOP + RAL + cART
    Arm description
    		 ABVD+RAL+TDF/FTC R-CHOP+RAL+TDF/FTC R-CHOP+RAL+3TC+DDI
    Arm type
    		 Active comparator

    Investigational medicinal product name
    RALTEGRAVIR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RALTEGRAVIR 400 MG/bid STANDARD DOSAGE

    Number of subjects in period 2
    		ABVD or R-CHOP + RAL + cART
    Started
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABVD or CHOP treatment+cART ongoing
    Reporting group description
    		 -

    Reporting group values
    		 ABVD or CHOP treatment+cART ongoing Total
    Number of subjects
    		 3 3
    Age categorical
    Adult patients
    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)
    		 3 3
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 3 3
    Subject analysis sets

    Subject analysis set title
    Prospective evaluation per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Prospective evaluation on HIV-subjects treated with 2 NRTIs in association with boosted PI or NNRTI receiving R-CHOP or ABVD chemotherapy for NHL and HL.

    Subject analysis sets values
    		 Prospective evaluation per protocol
    Number of subjects
    3
    Age categorical
    Adult patients
    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)
    3
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    ABVD or R-CHOP + ongoing cART
    Reporting group description
    		 -
    Reporting group title
    ABVD or R-CHOP + RAL + cART
    Reporting group description
    		 ABVD+RAL+TDF/FTC R-CHOP+RAL+TDF/FTC R-CHOP+RAL+3TC+DDI

    Subject analysis set title
    Prospective evaluation per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Prospective evaluation on HIV-subjects treated with 2 NRTIs in association with boosted PI or NNRTI receiving R-CHOP or ABVD chemotherapy for NHL and HL.

    Primary: PK concentration of doxorubicine co-administered with antiretroviral therapy and DX PK after switch to Raltegravir

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    End point title
    		 PK concentration of doxorubicine co-administered with antiretroviral therapy and DX PK after switch to Raltegravir
    End point description
    11 timepoints of PK concentration at baseline (period 1) and 11 timepoints of PK concentration at period 2 (chemotherapy + raltegravir)
    End point type
    Primary
    End point timeframe
    11 timepoints of PK concentration at baseline (period 1) and 11 timepoints of PK concentration at period 2 (chemotherapy + raltegravir)
    End point values
    		 ABVD or R-CHOP + ongoing cART ABVD or R-CHOP + RAL + cART
    Number of subjects analysed
    3
    3
    Units: pharmacokinetic
    3
    3
    Statistical analysis title
    		 Per protocol
    Statistical analysis description
    per protocol
    Comparison groups
    ABVD or R-CHOP + ongoing cART v ABVD or R-CHOP + RAL + cART
    Number of subjects included in analysis
    6
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 per protocol
    Confidence interval
    Notes
    [1] - per protocol based on 3 subject completed
    [2] - Analysis per protocol based on 3 subject completed P-value is not applicable

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Untill the end of the participation in the study (end of treatment with raltegravir)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    R-CHOP + ARV
    Reporting group description
    		 R-CHOP + DRV/r+TDF/FTC (first cycle) R-CHOP + RAL + TDF/FTC (second cycle)

    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: None non serious Adverse Events were observed during the study
    Serious adverse events
    		 R-CHOP + ARV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Dead for progression of diseases
         subjects affected / exposed [2]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: 1 subject dead for progression of diseases
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 R-CHOP + ARV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)

    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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