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    Clinical Trial Results:
    A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

    Summary
    EudraCT number
    		 2015-001339-19
    Trial protocol
    		 Outside EU/EEA   GB  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Aug 2021
    First version publication date
    14 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-311-1269
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02285114
    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, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001577-PIP02-14
    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?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    13 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to confirm the tenofovir alafenamide (TAF) dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of emtricitabine/tenofovir alafenamide (F/TAF) in human immunodeficiency virus-1 (HIV-1) infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid [RNA] for a period of at least 6 months) while on a stable nucleoside reverse transcriptase inhibitor (NRTI) containing regimen.
    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
    		 A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG). Boosted protease inhibitors (PIs) of the participant's pre-existing regimen may include one of the following: ATV, LPV, or DRV.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jan 2015
    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
    Panama: 19
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    South Africa: 12
    Worldwide total number of subjects
    41
    EEA total number of subjects
    0
    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)
    12
    Adolescents (12-17 years)
    29
    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 Panama, South Africa, and United States. The first participant was screened on 20 January 2015. Participants will not be enrolled in Cohort 2 (Group 1 and 2 in Part B), Cohorts 3 and 4 (Parts A and B).

    Pre-assignment
    Screening details
    		 The last Week 48 study visit for participants in Cohort 1 and 2, Group 1 and 2 in Part A occurred on 13 December 2019. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 F/TAF+3rd ARV Agent (Cohort 1)
    Arm description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent, administered orally once daily

    Arm title
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)
    Arm description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg administered orally once daily

    Arm title
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Arm description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120/15 mg administered orally once daily

    Number of subjects in period 1 [1]
    		F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Started
    28
    9
    3
    Completed
    7
    2
    0
    Not completed
    21
    7
    3
         Still on study
    21
    5
    2
         Withdrew Consent
    -
    -
    1
         Investigator's Discretion
    -
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was enrolled in Cohort 1 was not treated and was not included in the Safety Analysis Set for Period 1 table reported above.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Reporting group values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A) Total
    Number of subjects
    		 28 9 3 40
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14 ( 1.6 ) 10 ( 1.0 ) 7 ( 1.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 5 2 19
        Male
    		 16 4 1 21
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 14 5 1 20
        Not Hispanic or Latino
    		 14 4 2 20
    Race
    Units: Subjects
        Asian
    		 1 0 0 1
        Black
    		 12 4 2 18
        White
    		 3 0 0 3
        Other
    		 12 5 1 18
    Human Immunodeficiency Virus, Type 1 Ribonucleic Acid (HIV-1 RNA)
    Units: Subjects
        < 50 copies/mL
    		 27 9 3 39
        ≥ 50 copies/mL
    		 1 0 0 1
    Cluster of Differentiation 4 (CD4) Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 909 ( 242.7 ) 871 ( 364.8 ) 1209 ( 306.3 ) -
    CD4 Percentage (%)
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    		 36.1 ( 6.40 ) 36.7 ( 4.35 ) 36.1 ( 3.35 ) -

    End points

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    End points reporting groups
    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Subject analysis set title
    F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV)

    Subject analysis set title
    F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Primary: Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF)

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    End point title
    		 Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF) [1]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Participants in the Intensive PK (IPK) Analysis Set (participants who were enrolled in Cohort 1 for IPK evaluation, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest [e.g., emtricitabine {FTC}, TAF, and tenofovir {TFV}]) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Any time at Week 2 visit
    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: No statistical comparison was planned or performed.
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    139.9 ( 113.23 )
    200.6 ( 83.80 )
    No statistical analyses for this end point

    Primary: PK Parameter (Cohort 2): AUCtau of TAF

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    End point title
    		 PK Parameter (Cohort 2): AUCtau of TAF [2] [3]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). The PK Analysis Set included all participants who were enrolled into the study, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., FTC, TAF, and TFV).
    End point type
    Primary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    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: No statistical comparison was planned or performed.
    [3] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    210.8 ( 97.35 )
    220.2 ( 187.96 )
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24 [4]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. The Safety Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Primary
    End point timeframe
    Baseline through Week 24
    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
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Any AEs
    82.1
    66.7
    66.7
        SAEs
    7.1
    0
    0
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV

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    End point title
    		 PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax of TAF
    89.1 ( 77.63 )
    139.3 ( 76.17 )
        Cmax of FTC
    2259.2 ( 470.75 )
    2320.0 ( 482.18 )
        Cmax of TFV
    21.2 ( 4.89 )
    11.6 ( 2.74 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2): Cmax of TAF, FTC, and TFV

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    End point title
    		 PK Parameter (Cohort 2): Cmax of TAF, FTC, and TFV [5]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [5] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax of TAF
    230.4 ( 264.70 )
    232.0 ( 253.59 )
        Cmax of FTC
    2074.4 ( 565.91 )
    2020.0 ( 1151.91 )
        Cmax of TFV
    55.8 ( 19.20 )
    48.1 ( 8.07 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Clast of TAF

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    End point title
    		 PK Parameter (Cohort 1): Clast of TAF
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
        arithmetic mean (standard deviation)
    2.2 ( 0.98 )
    5.5 ( 3.76 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2) : Clast of TAF

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    End point title
    		 PK Parameter (Cohort 2) : Clast of TAF [6]
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [6] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: ng/mL
        arithmetic mean (standard deviation)
    2.9 ( 2.32 )
    2.1 ( 0.86 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): CL/F of TAF

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    End point title
    		 PK Parameter (Cohort 1): CL/F of TAF
    End point description
    CL/F is defined as the apparent oral clearance following administration of the drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: L/hr
        arithmetic mean (standard deviation)
    129.8 ( 101.67 )
    143.4 ( 53.55 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2): CL/F of TAF

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    End point title
    		 PK Parameter (Cohort 2): CL/F of TAF [7]
    End point description
    CL/F is defined as the apparent oral clearance following administration of the drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [7] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: L/hr
        arithmetic mean (standard deviation)
    174.3 ( 156.75 )
    102.1 ( 60.75 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Vz/F of TAF

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    End point title
    		 PK Parameter (Cohort 1): Vz/F of TAF
    End point description
    Vz/F is defined as the apparent volume of distribution of the drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: liters
        arithmetic mean (standard deviation)
    87.3 ( 60.68 )
    95.3 ( 43.47 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2): Vz/F of TAF

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    End point title
    		 PK Parameter (Cohort 2): Vz/F of TAF [8]
    End point description
    Vz/F is defined as the apparent volume of distribution of the drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [8] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: liters
        arithmetic mean (standard deviation)
    160.8 ( 145.57 )
    63.1 ( 63.39 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): AUCtau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 1): AUCtau of FTC and TFV
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUCtau of FTC
    14769.9 ( 4481.23 )
    14339.8 ( 6099.55 )
        AUCtau of TFV
    415.5 ( 105.92 )
    193.2 ( 46.73 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2): AUCtau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 2): AUCtau of FTC and TFV [9]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Participants in the PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [9] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUCtau of FTC (N = 8, 3)
    12360.8 ( 2928.36 )
    11171.7 ( 2921.64 )
        AUCtau of TFV (N = 9, 3)
    999.4 ( 409.33 )
    908.2 ( 90.62 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Ctau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 1): Ctau of FTC and TFV
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctau of FTC
    223.4 ( 482.59 )
    301.7 ( 624.77 )
        Ctau of TFV
    15.7 ( 4.11 )
    6.7 ( 3.00 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2): Ctau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 2): Ctau of FTC and TFV [10]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [10] - 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 end point is reporting statistics for Cohort 2 only.
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    9
    3
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctau of FTC (N = 8, 3)
    75.4 ( 22.71 )
    75.4 ( 27.63 )
        Ctau of TFV (N = 9, 3)
    34.8 ( 16.39 )
    30.9 ( 3.53 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing TEAEs and SAEs Through Week 48

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    End point title
    		 Percentage of Participants Experiencing TEAEs and SAEs Through Week 48
    End point description
    An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Any AEs
    85.7
    77.8
    66.7
        SAEs
    7.1
    0
    0
    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 United States Food and Drug Administration (US FDA)-Defined 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 United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. The Full Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
        number (not applicable)
    92.9
    100.0
    66.7
    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 US FDA-Defined 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 US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
        number (not applicable)
    89.3
    77.8
    66.7
    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. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    8
    2
    Units: cells/µL
        arithmetic mean (standard deviation)
    -130 ( 272.6 )
    68 ( 352.5 )
    -299 ( 48.8 )
    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. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    2
    Units: cells/µL
        arithmetic mean (standard deviation)
    -105 ( 162.9 )
    210 ( 406.5 )
    -124 ( 37.5 )
    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. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    8
    2
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.2 ( 3.84 )
    1.3 ( 2.40 )
    0.6 ( 5.80 )
    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. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    7
    2
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.2 ( 3.41 )
    0.7 ( 3.52 )
    3.7 ( 7.28 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Palatability of F/TAF Formulation

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    End point title
    		 Percentage of Participants With Palatability of F/TAF Formulation
    End point description
    Palatability was reported based on the product taste of being normal or abnormal. Missing data were reported separately. Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. Here, '99999' signifies data not available since no participants were analyzed at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 2 (for Cohort 1), Week 2 and Week 4 (for Cohort 2)
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Week 2: Product Taste Normal (N=28,9,3)
    89.3
    77.8
    66.7
        Week 2: Product Taste Abnormal (N=28,9,3)
    0
    22.2
    0
        Week 2: Missing (N=28,9,3)
    10.7
    0
    33.3
        Week 4: Product Taste Normal (N=0,9,3)
    99999
    66.7
    100.0
        Week 4: Product Taste Abnormal (N=0,9,3)
    99999
    33.3
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Acceptability of F/TAF Formulation

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    End point title
    		 Percentage of Participants With Acceptability of F/TAF Formulation
    End point description
    Acceptability was reported based on the the product size and shape. Missing data were reported separately. Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 4
    End point values
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Acceptable Shape and Size
    89.3
    100.0
    100.0
        Product Shape Issue
    0
    0
    0
        Product Size Issue
    0
    0
    0
        Missing
    10.7
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to Week 48
    Adverse event reporting additional description
    Safety Analysis Set: all participants who were enrolled in study and had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)

    Serious adverse events
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A) F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 28 (75.00%)
    7 / 9 (77.78%)
    2 / 3 (66.67%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 28 (25.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    7
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Vernal keratoconjunctivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    5 / 28 (17.86%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    6
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 9 (22.22%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    Nausea
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    Nasal congestion
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 9 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    5
    6
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 9 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    1
    0
    3
    Hordeolum
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Influenza
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2014
    - Study design has been updated from “tenofovir disoproxil fumarate (TDF)-containing regimen” to “2-NRTI-containing regimen” as stable TDF use prior to study entry is no longer a requirement. - There is no longer a requirement to stratify participants by 3rd ARV agents. - Participants are now allowed to use ATV/r and DVR/r as 3rd ARV. - Information regarding recommended F/TAF and FTC/TDF doses for Cohort 2 has been included. - Timing of assessments specific to Cohort 2 is included.
    02 Aug 2017
    - F/TAF was approved in the US and EU for use in adolescents based on Genvoya data, which provides support for opening Cohorts 2 enrollment and adding Cohorts 3 and 4. Dose, statistical methods and study procedures have been amended as appropriate. - FTC/TDF reference therapy has been removed from Cohort 2 since F/TAF has been approved for use in adolescents. Participants will no longer be randomized 2:1 ratio into F/TAF and FTC/TDF. Instead, all participants enrolled into Cohorts 2, 3 and 4 will receive F/TAF. - Treatment Assessment period has been changed from 96 weeks to 48 weeks since FTC/TDF reference therapy has been removed from Cohort 2. Study procedures have been updated to reflect the change. Gilead was interested in long-term (96-week) evaluation of TDF on bone and renal parameters during the initial design of this study due to associations between TDF and early-onset bone demineralization in adults and nephrotoxicity, and because the renal and bone safety of TAF had not yet been established. However, since the initiation of Study GS-US-311-1269, recent studies have demonstrated that renal and bone effects were significantly reduced in participants receiving TAF- versus TDF-containing regimens. As such, randomization to TDF is not deemed pertinent to the clinical development of pediatric DVY and has been removed as the reference therapy from Study GS-US-311-1269. The elimination of the TDF reference therapy arm in the study thus allows for a shortened treatment duration of 48 weeks.

    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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