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    Clinical Trial Results:
    A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

    Summary
    EudraCT number
    		 2011-004963-56
    Trial protocol
    		 GB   DE   BE   AT   ES   IT  
    Global end of trial date
    01 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    23 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-236-0121
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01495702
    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
    Clinical Trial Information Desk, Gilead Sciences International Ltd, +44 1223897 496, clinical.trials@gilead.com
    Scientific contact
    Clinical Trial Information Desk, Gilead Sciences International Ltd, +44 1223897 496, clinical.trials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Puerto Rico: 6
    Country: Number of subjects enrolled
    United States: 229
    Worldwide total number of subjects
    439
    EEA total number of subjects
    173
    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)
    436
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 13 December 2011. The last study visit occurred on 01 December 2014.

    Pre-assignment
    Screening details
    		 571 participants were screened.

    Period 1
    Period 1 title
    Randomized Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stribild
    Arm description
    		 Participants switched from their baseline treatment regimen to Stribild STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Stribild®, EVG/COBI/FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg) STR once daily

    Arm title
    		 NNRTI+FTC/TDF
    Arm description
    		 Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Truvada®, FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine/tenofovir disoproxil fumarate (200/300 mg) administered according to prescribing information

    Number of subjects in period 1 [1]
    		Stribild NNRTI+FTC/TDF
    Started
    291
    143
    Completed
    266
    119
    Not completed
    25
    24
         Withdrew Consent
    10
    18
         Adverse event, non-fatal
    2
    2
         Participant Noncompliance
    1
    -
         Death
    1
    -
         Lost to Follow-up
    4
    3
         Investigators Discretion
    2
    -
         Protocol Violation
    3
    1
         Lack of efficacy
    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: 5 participants who were enrolled but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stribild
    Arm description
    		 Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Stribild®, EVG/COBI/FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg) STR once daily

    Arm title
    		 NNRTI+FTC/TDF
    Arm description
    		 Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Truvada®, FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine/tenofovir disoproxil fumarate (200/300 mg) administered according to prescribing information

    Number of subjects in period 2 [2]
    		Stribild NNRTI+FTC/TDF
    Started
    26
    2
    Completed
    26
    2
    Notes
    [2] - 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: Of those who completed the Randomized Phase (Stribild: n = 291; NNRTI+FTC/TDF: n = 143), 26 participants randomized to Stribild and 2 participants randomized to NNRTI+FTC/TDF entered the Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Participants switched from their baseline treatment regimen to Stribild STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.

    Reporting group title
    NNRTI+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.

    Reporting group values
    		 Stribild NNRTI+FTC/TDF Total
    Number of subjects
    		 291 143 434
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42 ± 9.6 40 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 23 9 32
        Male
    		 268 134 402
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 4 9 13
        Black or African Heritage
    		 49 23 72
        Native Hawaiian or Pacific Islander
    		 1 0 1
        White
    		 231 109 340
        Other
    		 4 2 6
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 30 16 46
        Non-Hispanic/Latino
    		 261 127 388
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 285 141 426
        50 to < 200 copies/mL
    		 4 2 6
        200 to < 400 copies/mL
    		 0 0 0
        ≥ 400 copies/mL
    		 2 0 2
    CD4+ Cell Count Category
    Units: Subjects
        ≤ 50 cells/μL
    		 0 0 0
        51 to ≤ 200 cells/μL
    		 4 1 5
        201 to ≤ 350 cells/μL
    		 26 20 46
        351 to ≤ 500 cells/μL
    		 75 33 108
        > 500 cells/μL
    		 186 89 275
    HIV Disease Status
    Units: Subjects
        Asymptomatic
    		 225 115 340
        Symptomatic HIV Infections
    		 36 14 50
        AIDS
    		 30 14 44
    CD4+ Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 586 ± 210.3 593 ± 224.6 -

    End points

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    End points reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Participants switched from their baseline treatment regimen to Stribild STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.

    Reporting group title
    NNRTI+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
    Reporting group title
    Stribild
    Reporting group description
    		 Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.

    Reporting group title
    NNRTI+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
    End point description
    • The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time. • Analysis Population Description: Full analysis set includes randomized subjects who took at least one dose of study drug, had no documented resistance and were on NNRTI at screening.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Stribild NNRTI+FTC/TDF
    Number of subjects analysed
    290
    143
    Units: percentage of participants
        number (not applicable)
    93.4
    88.1
    Statistical analysis title
    		 Difference in proportions
    Statistical analysis description
    The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA < 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.
    Comparison groups
    Stribild v NNRTI+FTC/TDF
    Number of subjects included in analysis
    433
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.066
    Method
    		 Fisher exact
    Parameter type
    		 Difference in proportions
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 12
    Notes
    [1] - The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Stribild NNRTI+FTC/TDF
    Number of subjects analysed
    290
    143
    Units: percentage of participants
        number (not applicable)
    86.6
    80.4
    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
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 Stribild NNRTI+FTC/TDF
    Number of subjects analysed
    270
    126
    Units: cells/µL
        arithmetic mean (standard deviation)
    56 ± 147.3
    58 ± 179.3
    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
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 Stribild NNRTI+FTC/TDF
    Number of subjects analysed
    256
    116
    Units: cells/µL
        arithmetic mean (standard deviation)
    83 ± 166.7
    101 ± 156.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment (average exposure = 90 weeks) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set participants were randomized and received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase. Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.

    Reporting group title
    NNRTI+FTC/TDF
    Reporting group description
    		 Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase. Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/ TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.

    Reporting group title
    All Stribild
    Reporting group description
    		 Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.

    Serious adverse events
    		 Stribild NNRTI+FTC/TDF All Stribild
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 291 (8.25%)
    7 / 143 (4.90%)
    26 / 293 (8.87%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 291 (0.34%)
    2 / 143 (1.40%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 143 (0.70%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 143 (0.70%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 291 (0.00%)
    2 / 143 (1.40%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 143 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 143 (0.70%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    		 Stribild NNRTI+FTC/TDF All Stribild
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    154 / 291 (52.92%)
    66 / 143 (46.15%)
    154 / 293 (52.56%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    29 / 291 (9.97%)
    8 / 143 (5.59%)
    29 / 293 (9.90%)
         occurrences all number
    29
    8
    29
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 291 (6.53%)
    2 / 143 (1.40%)
    19 / 293 (6.48%)
         occurrences all number
    23
    2
    23
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    30 / 291 (10.31%)
    11 / 143 (7.69%)
    30 / 293 (10.24%)
         occurrences all number
    33
    12
    33
    Nausea
         subjects affected / exposed
    24 / 291 (8.25%)
    4 / 143 (2.80%)
    24 / 293 (8.19%)
         occurrences all number
    25
    4
    25
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    24 / 291 (8.25%)
    5 / 143 (3.50%)
    24 / 293 (8.19%)
         occurrences all number
    32
    6
    32
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    22 / 291 (7.56%)
    11 / 143 (7.69%)
    22 / 293 (7.51%)
         occurrences all number
    22
    11
    22
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    23 / 291 (7.90%)
    8 / 143 (5.59%)
    23 / 293 (7.85%)
         occurrences all number
    23
    8
    23
    Arthralgia
         subjects affected / exposed
    19 / 291 (6.53%)
    5 / 143 (3.50%)
    19 / 293 (6.48%)
         occurrences all number
    19
    6
    19
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    33 / 291 (11.34%)
    15 / 143 (10.49%)
    33 / 293 (11.26%)
         occurrences all number
    41
    19
    41
    Sinusitis
         subjects affected / exposed
    21 / 291 (7.22%)
    5 / 143 (3.50%)
    21 / 293 (7.17%)
         occurrences all number
    23
    5
    23
    Syphilis
         subjects affected / exposed
    17 / 291 (5.84%)
    10 / 143 (6.99%)
    17 / 293 (5.80%)
         occurrences all number
    19
    10
    19
    Nasopharyngitis
         subjects affected / exposed
    30 / 291 (10.31%)
    17 / 143 (11.89%)
    30 / 293 (10.24%)
         occurrences all number
    41
    24
    41

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2011
    • Extended the study from 48 to 96 weeks and removed the switch to STB at Week 48 for subjects in Treatment Group 2 based on feedback from the US Food and Drug Administration (FDA); updated Study Schema • Updated secondary study objectives based on feedback from the US FDA • Clarified and updated the inclusion and exclusion criteria • Updated the Table of Disallowed and Discouraged Medications to reflect draft STB label
    27 Jun 2012
    • Updated inclusion criteria to allow subjects to be on their first or second ARV drug regimen (to be more reflective of the target patient population), to change estimated glomerular filtration rate (eGFR) entry criteria from ≥ 90 mL/min to ≥ 70 mL/min, and to clarify that subjects could be rescreened with approval from the medical monitor • Clarified the duration of the study throughout the protocol • Clarified the thymidine analog-associated mutations • Updated the screening visit procedures to align with the directive of DSPH group • Updated the CT3 guidance in Section 7.4 (as outlined in Administrative Letter 2) • Updated the new contact information for DSPH and remove requirement to email safety event reports due to restrictive data privacy laws in some countries • Changed the after study reporting requirements • Updated the definitions of childbearing potential, postmenopausal, and contraception requirements • Updated Study Procedures Table footnotes

    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.
    There were no limitations affecting the analysis or results.
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