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    Clinical Trial Results:
    A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects

    Summary
    EudraCT number
    		 2013-001969-16
    Trial protocol
    		 IT   DE   ES   Outside EU/EEA  
    Global end of trial date
    03 Nov 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jun 2018
    First version publication date
    10 May 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    • Added more clarification to some endpoints • Changed measure type from "median" to "mean" for "Change from baseline in CD4 Cell Count at Week 24" endpoint (typo) • Updated time frame for “Age of First Menses” endpoint for clarification • Updated measure description for “Adherence to EVG” endpoint and changed unit of measure to “percentage of pills”

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-183-0160
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01923311
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences International Ltd., GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences International Ltd., GileadClinicalTrials@gilead.com
    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
    03 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA > 1,000 copies/mL in Cohort 2, Part A only) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to < 18 years old) containing Part B only.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Uganda: 6
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Thailand: 7
    Country: Number of subjects enrolled
    South Africa: 7
    Worldwide total number of subjects
    31
    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)
    16
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, Asia, and Africa. The first participant was screened on 26 August 2013. The last study visit occurred on 03 November 2017.

    Pre-assignment
    Screening details
    		 48 participants were screened. The study was discontinued after enrollment of only Cohort 1, Part B and Cohort 2, Part A. The study close-out was triggered by the voluntary withdrawal of single-agent Vitekta® sale based solely on low utilization of the product, and was not a result of any ongoing or new safety issue.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL
    Arm description
    		 Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EVG 50 mg
    Investigational medicinal product code
    Other name
    Vitekta®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet(s) administered orally once daily

    Investigational medicinal product name
    EVG 85 mg
    Investigational medicinal product code
    Other name
    Vitekta®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    85 mg tablet(s) administered orally once daily

    Investigational medicinal product name
    EVG 150 mg
    Investigational medicinal product code
    Other name
    Vitekta®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg tablet(s) administered orally once daily

    Arm title
    		 Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Arm description
    		 EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    EVG 50 mg
    Investigational medicinal product code
    Other name
    Vitekta®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet(s) administered orally once daily

    Investigational medicinal product name
    EVG 85 mg
    Investigational medicinal product code
    Other name
    Vitekta®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    85 mg tablet(s) administered orally once daily

    Number of subjects in period 1
    		Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Started
    17
    14
    Completed
    0
    13
    Not completed
    17
    1
         Withdrew Consent
    1
    -
         Non-Compliance with Study Drug
    2
    1
         Investigator's Discretion
    1
    -
         Pregnancy
    1
    -
         Study Terminated by Sponsor
    12
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL
    Reporting group description
    		 Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.

    Reporting group title
    Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Reporting group description
    		 EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)

    Reporting group values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL Total
    Number of subjects
    		 17 14 31
    Age categorical
    Units: Subjects
    Age continuous
    Safety Analysis Set: all participants who were enrolled into the study and received at least 1 dose of study drug.
    Units: years
        arithmetic mean (standard deviation)
    		 14 ± 2.9 9 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    		 11 6 17
        Male
    		 6 8 14
    Race
    Units: Subjects
        Asian
    		 5 2 7
        Black
    		 11 10 21
        White
    		 0 2 2
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 17 13 30
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 0 13 13
        ≥ 50 to ≤ 1000 copies/mL
    		 3 1 4
        > 1000 to ≤ 100000 copies/mL
    		 13 0 13
        > 100000 copies/mL
    		 1 0 1
    Cluster of Differentiation (CD4) Cell Category
    Units: Subjects
        < 50 cells/uL
    		 0 0 0
        ≥ 50 to < 200 cells/uL
    		 6 1 7
        ≥ 200 to < 350 cells/uL
    		 3 0 3
        ≥ 350 to < 500 cells/uL
    		 4 0 4
        ≥ 500 cells/uL
    		 4 13 17
    Type of PI in Background Regimen (Excluding Ritonavir)
    Units: Subjects
        atazanavir
    		 8 1 9
        darunavir
    		 3 0 3
        lopinavir
    		 6 13 19
    HIV-1 RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 4.21 ± 0.802 1.33 ± 0.204 -
    Cluster of Differentiation (CD4) Cell Count
    Units: cells/uL
        arithmetic mean (standard deviation)
    		 356.6 ± 249.45 810.8 ± 303.29 -
    Cluster of Differentiation (CD4) Percentage
    Units: percentage (%)
        arithmetic mean (standard deviation)
    		 17.8 ± 9.60 35.5 ± 9.11 -

    End points

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    End points reporting groups
    Reporting group title
    Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL
    Reporting group description
    		 Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.

    Reporting group title
    Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Reporting group description
    		 EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)

    Subject analysis set title
    Age 6 to <12 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

    Primary: Pharmacokinetic (PK) Parameter: AUCtau of EVG

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    End point title
    		 Pharmacokinetic (PK) Parameter: AUCtau of EVG [1]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Intensive PK Analysis Set (EVG): all enrolled participants who received at least 1 dose of study drug and for whom steady-state pharmacokinetic profiles of the analyte of interest at the Intensive PK visit are evaluable. Includes 12 participants with screening HIV-1 RNA < 50 copies/mL and 2 participants with screening HIV-1 RNA > 1000 copies/mL.
    End point type
    Primary
    End point timeframe
    Predose and up to 12 hours postdose on Day 10
    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 statistical analysis of this primary endpoint is provided in the attachment.
    End point values
    		 Age 6 to <12 Years
    Number of subjects analysed
    14
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    24028.3 ± 7302.44
    Attachments
    		 Primary_Endpoint(1)_StatsAnalysis
    No statistical analyses for this end point

    Primary: Pharmacokinetic (PK) Parameter: Cmax of EVG

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    End point title
    		 Pharmacokinetic (PK) Parameter: Cmax of EVG [2]
    End point description
    Cmax is defined as the maximum concentration of drug. Intensive PK Analysis Set (EVG).
    End point type
    Primary
    End point timeframe
    Predose and up to 12 hours postdose on Day 10
    Notes
    [2] - 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 statistical analysis of this primary endpoint is provided in the attachment.
    End point values
    		 Age 6 to <12 Years
    Number of subjects analysed
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    2022.1 ± 599.94
    Attachments
    		 Primary_Endpoint(2)_StatsAnalysis
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing Treatment-emergent Adverse Events

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    End point title
    		 Percentage of Participants Experiencing Treatment-emergent Adverse Events [3]
    End point description
    Safety Analysis Set
    End point type
    Primary
    End point timeframe
    Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
    Notes
    [3] - 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: No statistical comparison was planned or performed.
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    14
    Units: percentage of participants
        number (not applicable)
    100.0
    35.7
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing Laboratory Abnormalities

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    End point title
    		 Percentage of Participants Experiencing Laboratory Abnormalities [4]
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. Participants in the Safety Analysis Set were analyzed. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).
    End point type
    Primary
    End point timeframe
    Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
    Notes
    [4] - 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: No statistical comparison was planned or performed.
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    14
    Units: percentage of participants
    number (not applicable)
        Grade 1
    11.8
    50.0
        Grade 2
    35.3
    21.4
        Grade 3
    35.3
    7.1
        Grade 4
    17.6
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: Ctau of EVG

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    End point title
    		 Pharmacokinetic (PK) Parameter: Ctau of EVG
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Intensive PK Analysis Set (EVG).
    End point type
    Secondary
    End point timeframe
    Predose and up to 12 hours postdose on Day 10
    End point values
    		 Age 6 to <12 Years
    Number of subjects analysed
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    494.3 ± 261.05
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: CL/F of EVG

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    End point title
    		 Pharmacokinetic (PK) Parameter: CL/F of EVG
    End point description
    CL/F is defined as the apparent oral clearance following administration of the drug. Intensive PK Analysis set (EVG)
    End point type
    Secondary
    End point timeframe
    Predose and up to 12 hours postdose on Day 10
    End point values
    		 Age 6 to <12 Years
    Number of subjects analysed
    14
    Units: mL/h
        arithmetic mean (standard deviation)
    2863.5 ± 871.07
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: Vz/F of EVG

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    End point title
    		 Pharmacokinetic (PK) Parameter: Vz/F of EVG
    End point description
    Vz/F is defined as the apparent volume of distribution of the drug. Participants in the Intensive PK Analysis Set: EVG with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose and up to 12 hours postdose on Day 10
    End point values
    		 Age 6 to <12 Years
    Number of subjects analysed
    13
    Units: mL
        arithmetic mean (standard deviation)
    39508.3 ± 14071.51
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    0 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    76.5 (50.1 to 93.2)
    ( to )
    Notes
    [5] - Week 24 HIV-1 RNA copies were not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    0 [6]
    Units: percentage of participants
        number (confidence interval 95%)
    58.8 (32.9 to 81.6)
    ( to )
    Notes
    [6] - Week 48 HIV-1 RNA copies were not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm

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    End point title
    		 Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    0 [7]
    Units: percentage of participants
        number (confidence interval 95%)
    82.4 (56.6 to 96.2)
    ( to )
    Notes
    [7] - Week 24 HIV-1 RNA copies were not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm

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    End point title
    		 Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    0 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    76.5 (50.1 to 93.2)
    ( to )
    Notes
    [8] - Week 48 HIV-1 RNA copies were not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24

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    End point title
    		 Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    16
    0 [9]
    Units: Log₁₀ copies/mL
        arithmetic mean (standard deviation)
    -2.44 ± 1.132
    ±
    Notes
    [9] - Week 24 data for participants was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48

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    End point title
    		 Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    15
    0 [10]
    Units: Log₁₀ copies/ mL
        arithmetic mean (standard deviation)
    -2.23 ± 1.293
    ±
    Notes
    [10] - Week 48 data for participants was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count at Week 24

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    End point title
    		 Change From Baseline in CD4 Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    16
    0 [11]
    Units: cells/uL
        arithmetic mean (standard deviation)
    77.6 ± 138.06
    ±
    Notes
    [11] - Week 24 CD4 Cell Count data was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count at Week 48

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    End point title
    		 Change From Baseline in CD4 Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    15
    0 [12]
    Units: cells/uL
        arithmetic mean (standard deviation)
    131.3 ± 195.04
    ±
    Notes
    [12] - Week 48 CD4 Cell Count data was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 24

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    16
    0 [13]
    Units: Percentage (%)
        arithmetic mean (standard deviation)
    3.56 ± 4.109
    ±
    Notes
    [13] - Week 24 CD4 Percentage data was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 48

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    15
    0 [14]
    Units: percentage (%)
        arithmetic mean (standard deviation)
    5.31 ± 5.772
    ±
    Notes
    [14] - Week 48 CD4 Percentage data was not analyzed due to the short duration of treatment (10 days).
    No statistical analyses for this end point

    Secondary: Tanner Stage Evaluation by Sex at Week 24: Pubic Hair

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    End point title
    		 Tanner Stage Evaluation by Sex at Week 24: Pubic Hair
    End point description
    Tanner Stage at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17 [15]
    0 [16]
    Units: participants
        Female: Stage 1
    1
        Female: Stage 2
    0
        Female: Stage 3
    4
        Female: Stage 4
    5
        Female: Stage 5
    1
        Female: Missing
    0
        Male: Stage 1
    2
        Male: Stage 2
    2
        Male: Stage 3
    0
        Male: Stage 4
    0
        Male: Stage 5
    2
        Male: Missing
    0
    Notes
    [15] - 11 females, 6 males
    [16] - No postbaseline assessments were scheduled in the protocol for these participants
    No statistical analyses for this end point

    Secondary: Tanner Stage Evaluation by Sex at Week 24: Breasts (Female), Genitalia (Male)

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    End point title
    		 Tanner Stage Evaluation by Sex at Week 24: Breasts (Female), Genitalia (Male)
    End point description
    Tanner Stage (breasts for females; genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17 [17]
    0 [18]
    Units: participants
        Female: Breasts- Stage 1
    0
        Female: Breasts- Stage 2
    0
        Female: Breasts- Stage 3
    3
        Female: Breasts- Stage 4
    5
        Female: Breasts- Stage 5
    3
        Female: Breasts- Missing
    0
        Male: Genitalia- Stage 1
    2
        Male: Genitalia- Stage 2
    2
        Male: Genitalia- Stage 3
    0
        Male: Genitalia- Stage 4
    0
        Male: Genitalia- Stage 5
    2
        Male: Genitalia- Missing
    0
    Notes
    [17] - 11 females, 6 males
    [18] - No postbaseline assessments were scheduled in the protocol for these participants
    No statistical analyses for this end point

    Secondary: Tanner Stage Evaluation by Sex at Week 48: Pubic Hair

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    End point title
    		 Tanner Stage Evaluation by Sex at Week 48: Pubic Hair
    End point description
    Tanner Stage at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17 [19]
    0 [20]
    Units: participants
        Female: Stage 1
    0
        Female: Stage 2
    1
        Female: Stage 3
    4
        Female: Stage 4
    4
        Female: Stage 5
    1
        Female: Missing
    1
        Male: Stage 1
    3
        Male: Stage 2
    1
        Male: Stage 3
    0
        Male: Stage 4
    1
        Male: Stage 5
    1
        Male: Missing
    0
    Notes
    [19] - 11 females, 6 males
    [20] - No postbaseline assessments were scheduled in the protocol for these participants.
    No statistical analyses for this end point

    Secondary: Tanner Stage Evaluation by Sex at Week 48: Breasts (Female), Genitalia (Male)

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    End point title
    		 Tanner Stage Evaluation by Sex at Week 48: Breasts (Female), Genitalia (Male)
    End point description
    Tanner Stage (breasts for females; genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17 [21]
    0 [22]
    Units: participants
        Female: Breasts- Stage 1
    0
        Female: Breasts- Stage 2
    0
        Female: Breasts- Stage 3
    2
        Female: Breasts- Stage 4
    5
        Female: Breasts- Stage 5
    3
        Female: Breasts- Missing
    1
        Male: Genitalia- Stage 1
    2
        Male: Genitalia- Stage 2
    2
        Male: Genitalia- Stage 3
    0
        Male: Genitalia- Stage 4
    0
        Male: Genitalia- Stage 5
    2
        Male: Genitalia- Missing
    0
    Notes
    [21] - 11 females, 6 males
    [22] - No postbaseline assessments were scheduled in the protocol for these participants
    No statistical analyses for this end point

    Secondary: Age of First Menses

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    End point title
    		 Age of First Menses
    End point description
    Age of first menses for female participants.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    11
    0 [23]
    Units: years
        arithmetic mean (standard deviation)
    13 ± 1.9
    ±
    Notes
    [23] - First menstruation cycle was not observed in any participant during or prior to the study.
    No statistical analyses for this end point

    Secondary: Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group

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    End point title
    		 Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group
    End point description
    Palatability was only to be assessed for participants taking EVG suspension formulation. As no participants were dosed with the EVG oral suspension formulation, no data are available on its palatability.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: percentage of participants
        number (not applicable)
    Notes
    [24] - Not assessed since none of the participants received EVG powder for oral suspension.
    [25] - Not assessed since none of the participants received EVG powder for oral suspension.
    No statistical analyses for this end point

    Secondary: Adherence to EVG

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    End point title
    		 Adherence to EVG
    End point description
    Adherence was calculated as the number of pills taken divided by number of pills prescribed. Participants in the Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
    End point values
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Number of subjects analysed
    17
    14
    Units: percentage of pills
        arithmetic mean (standard deviation)
    91.1 ± 8.94
    100.0 ± 0.00
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
    Adverse event reporting additional description
    Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL
    Reporting group description
    		 EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.

    Reporting group title
    Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Reporting group description
    		 EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)

    Serious adverse events
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmodium falciparum infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin candida
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 copies/mL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    5 / 14 (35.71%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Genital ulceration
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Asthma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Crystal urine present
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Lymph node palpable
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Muscle injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Parosmia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Dental caries
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Rash papular
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vitiligo
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 17 (64.71%)
    0 / 14 (0.00%)
         occurrences all number
    18
    0
    Otitis media acute
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Tonsillitis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Body tinea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Otitis externa
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Parotid abscess
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperamylasaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hyperlipasaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0

    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? Yes
    Date
    Interruption
    Restart date
    03 Nov 2017
    The study was discontinued after enrollment of only Cohort 1, Part B and Cohort 2, Part A. The study close-out was triggered by the voluntary withdrawal of single-agent Vitekta® sale based solely on low utilization of the product, and was not a result of any ongoing or new safety issue.
    -

    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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