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    Clinical Trial Results:
    A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations

    Summary
    EudraCT number
    		 2015-003616-20
    Trial protocol
    		 GB   FR  
    Global end of trial date
    28 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2021
    First version publication date
    01 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1439A-030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02629822
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    28 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naive HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations. This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    10
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at study sites in Canada, France, Spain, UK, and USA.

    Period 1
    Period 1 title
    Base Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DOR/3TC/TDF
    Arm description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doravirine/lamivudine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    MK-1439A DELSTRIGO™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-1439A FDC tablet of MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.

    Number of subjects in period 1
    		DOR/3TC/TDF
    Started
    10
    Completed
    7
    Not completed
    3
         Non-Compliance With Study Drug
    1
         Lost to follow-up
    2
    Period 2
    Period 2 title
    Extension Study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DOR/3TC/TDF
    Arm description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doravirine/lamivudine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    MK-1439A DELSTRIGO™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-1439A FDC tablet of MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.

    Number of subjects in period 2 [1]
    		DOR/3TC/TDF
    Started
    6
    Completed
    4
    Not completed
    2
         Adverse event, non-fatal
    1
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participation in the Extension Study was optional.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DOR/3TC/TDF
    Reporting group description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.

    Reporting group values
    		 DOR/3TC/TDF Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Participants
        Adults (18-64 years)
    		 10 10
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 37.1 ± 32.5 -
    Sex: Female, Male
    Units: Participants
        Female
    		 2 2
        Male
    		 8 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 3 3
        White
    		 5 5
        More than one race
    		 0 0
        Unknown or Not Reported
    		 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 6 6
        Unknown or Not Reported
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    DOR/3TC/TDF
    Reporting group description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
    Reporting group title
    DOR/3TC/TDF
    Reporting group description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.

    Primary: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48 [1]
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Primary
    End point timeframe
    Week 48
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    8
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (63.1 to 100.0)
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48

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    End point title
    		 Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48 [2]
    End point description
    The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. All participants who received ≥1 dose of MK-1439A were included.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    10
    Units: Percentage of Participants
        number (not applicable)
    90.0
    No statistical analyses for this end point

    Primary: Percentage of participants who discontinued treatment due to an AE up to Week 48

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    End point title
    		 Percentage of participants who discontinued treatment due to an AE up to Week 48 [3]
    End point description
    The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. All participants who received ≥1 dose of MK-1439A were included.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    10
    Units: Percentage of Participants
        number (not applicable)
    0.0
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96

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    End point title
    		 Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96 [4]
    End point description
    The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. All participants who received ≥1 dose of MK-1439A were included.
    End point type
    Primary
    End point timeframe
    Up to Week 96
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    10
    Units: Percentage of Participants
        number (not applicable)
    90.0
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96

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    End point title
    		 Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96 [5]
    End point description
    The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. All participants who received ≥1 dose of MK-1439A were included.
    End point type
    Primary
    End point timeframe
    Up to Week 96
    Notes
    [5] - 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    10
    Units: Percentage of Participants
        number (not applicable)
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    7
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (59.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    8
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (63.1 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    7
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (59.0 to 100.0)
    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
    The change from baseline in CD4 cell count at Week 48 was calculated. All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    8
    Units: Cells/mm^3
    arithmetic mean (confidence interval 95%)
        Baseline for the Week 48 Population
    409 (293.5 to 525.0)
        Change from Baseline at Week 48
    132 (24.4 to 239.8)
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4 Cell Count at Week 96

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    End point title
    		 Change from Baseline in CD4 Cell Count at Week 96
    End point description
    The change from baseline in CD4 cell count at Week 96 was calculated. All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 96
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    7
    Units: Cells/mm^3
    arithmetic mean (confidence interval 95%)
        Baseline for the Week 96 Population
    437 (323.9 to 550.7)
        Change from Baseline at Week 96
    153 (23.0 to 282.8)
    No statistical analyses for this end point

    Secondary: Time to Loss of Virologic Response

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    End point title
    		 Time to Loss of Virologic Response
    End point description
    The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement. All participants who experienced protocol-defined virologic failure, received ≥1 dose of MK-1439A, had baseline and later data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included. Participants who did not experience virologic failure were excluded from the analysis population.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    1
    Units: Days
        arithmetic mean (full range (min-max))
    166 (166 to 166)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Other pre-specified
    End point timeframe
    Week 192
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    4
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (39.8 to 100.0)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192

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    End point title
    		 Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192
    End point description
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Other pre-specified
    End point timeframe
    Week 192
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    4
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (39.8 to 100.0)
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in CD4 Cell Count at Week 192

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    End point title
    		 Change from Baseline in CD4 Cell Count at Week 192
    End point description
    The change from baseline in CD4 cell count at Week 192 was calculated. All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance-associated mutations were included.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1) and Week 192
    End point values
    		 DOR/3TC/TDF
    Number of subjects analysed
    4
    Units: Cells/mm^3
    arithmetic mean (confidence interval 95%)
        Baseline for the Week 192 Population
    479 (310.0 to 648.5)
        Change from Baseline at Week 192
    196 (27.4 to 364.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 192 weeks
    Adverse event reporting additional description
    All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    DOR/3TC/TDF Study Extension: Week 97 to Week 192
    Reporting group description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth from Day 1 to Week 96 in the Base Study.

    Reporting group title
    DOR/3TC/TDF Base Study: Day 1 to Week 96
    Reporting group description
    		 Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth from Week 96 to Week 192 in the optional Extension Study.

    Serious adverse events
    		 DOR/3TC/TDF Study Extension: Week 97 to Week 192 DOR/3TC/TDF Base Study: Day 1 to Week 96
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DOR/3TC/TDF Study Extension: Week 97 to Week 192 DOR/3TC/TDF Base Study: Day 1 to Week 96
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    9 / 10 (90.00%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Exposure to communicable disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Eye contusion
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dysaesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dystonia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Taste disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    4
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Anogenital dysplasia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Defaecation urgency
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    4
    Gastrointestinal tract irritation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Penile discharge
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    0
    4
    Neck pain
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Chlamydial infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hepatitis syphilitic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gonorrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Infected cyst
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 10 (30.00%)
         occurrences all number
    2
    5
    Influenza
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Oropharyngeal gonococcal infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Secondary syphilis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Proctitis gonococcal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Shigella infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Aug 2016
    AM1: The purpose for this amendment was to update study design and provide rationale/enrollment criteria for the Extension Study.
    05 Jun 2017
    AM2: The purpose of this amendment was to change the enrollment target.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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