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    Clinical Trial Results:
    A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/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
    		 2011-004483-30
    Trial protocol
    		 BE   DE   ES   AT   PT   GB   IT  
    Global end of trial date
    09 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2016
    First version publication date
    05 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-236-0115
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01475838
    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
    09 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single tablet regimen (STR) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF in maintaining HIV-1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) 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
    18 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 19
    Country: Number of subjects enrolled
    Spain: 50
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 54
    Country: Number of subjects enrolled
    Germany: 58
    Country: Number of subjects enrolled
    Italy: 61
    Country: Number of subjects enrolled
    United States: 125
    Country: Number of subjects enrolled
    Switzerland: 20
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Worldwide total number of subjects
    438
    EEA total number of subjects
    280
    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)
    434
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America and Europe. The first participant was screened on 18 November 2011. The last study visit occurred on 09 December 2014

    Pre-assignment
    Screening details
    		 632 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
    		 PI+RTV+FTC/TDF
    Arm description
    		 Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) 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
    FTC/TDF (200/300 mg) administered according to prescribing information

    Number of subjects in period 1 [1]
    		Stribild PI+RTV+FTC/TDF
    Started
    293
    140
    Completed
    263
    109
    Not completed
    30
    31
         Withdrew Consent
    10
    14
         Adverse event, non-fatal
    6
    1
         Participant Noncompliance
    1
    5
         Lost to Follow-up
    3
    4
         Investigators Discretion
    1
    2
         Pregnancy
    -
    1
         Protocol Violation
    9
    4
    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® 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®; E/C/F/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 administered orally once daily

    Arm title
    		 PI+RTV+FTC/TDF
    Arm description
    		 Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
    Arm type
    		 Experimental

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

    Number of subjects in period 2 [2]
    		Stribild PI+RTV+FTC/TDF
    Started
    42
    20
    Completed
    41
    20
    Not completed
    1
    0
         Participant Noncompliance
    1
    -
    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 = 293; PI/RTV/FTC/TDF: n = 140), 42 participants randomized to Stribild and 20 participants randomized to PI/RTV/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
    PI+RTV+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.

    Reporting group values
    		 Stribild PI+RTV+FTC/TDF Total
    Number of subjects
    		 293 140 433
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41 ( 9.7 ) 41 ( 8.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 19 62
        Male
    		 250 121 371
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 1 3
        Asian
    		 7 2 9
        Black or African Heritage
    		 43 20 63
        White
    		 234 113 347
        Other
    		 5 2 7
        Not Permitted
    		 2 2 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 42 17 59
        Non-Hispanic/Latino
    		 249 123 372
        Not Permitted
    		 2 0 2
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 291 137 428
        50 to < 200 copies/mL
    		 2 2 4
        200 to < 400 copies/mL
    		 0 0 0
        ≥ 400 copies/mL
    		 0 1 1
    CD4+ Cell Count Category
    Units: Subjects
        ≤ 50 cells/μL
    		 0 0 0
        51 to ≤ 200 cells/μL
    		 9 6 15
        201 to ≤ 350 cells/μL
    		 37 14 51
        351 to ≤ 500 cells/μL
    		 69 26 95
        > 500 cells/μL
    		 178 94 272
    HIV Disease Status
    Units: Subjects
        Asymptomatic
    		 214 105 319
        Symptomatic HIV Infections
    		 38 17 55
        AIDS
    		 41 18 59
    CD4+ Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 604 ( 274.6 ) 624 ( 269.9 ) -

    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
    PI+RTV+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) 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® 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
    PI+RTV+FTC/TDF
    Reporting group description
    		 Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF 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.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Stribild PI+RTV+FTC/TDF
    Number of subjects analysed
    290
    139
    Units: Percentage of participants
        number (not applicable)
    93.8
    87.1
    Statistical analysis title
    		 Difference in proportions
    Statistical analysis description
    The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV +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 PI+RTV+FTC/TDF group.
    Comparison groups
    Stribild v PI+RTV+FTC/TDF
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.025
    Method
    		 Fisher exact
    Parameter type
    		 Difference in proportions
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 13.7
    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
    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.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Stribild PI+RTV+FTC/TDF
    Number of subjects analysed
    290
    139
    Units: Percentage of Participants
        number (not applicable)
    86.9
    69.8
    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
    Analysis Population Description: Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 Stribild PI+RTV+FTC/TDF
    Number of subjects analysed
    270
    120
    Units: cells/μL
        arithmetic mean (standard deviation)
    40 ( 169.5 )
    32 ( 166.1 )
    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
    Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 Stribild PI+RTV+FTC/TDF
    Number of subjects analysed
    255
    104
    Units: cells/μL
        arithmetic mean (standard deviation)
    61 ( 196.5 )
    71 ( 173.4 )
    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 = 88 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 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
    PI+RTV+FTC/TDF
    Reporting group description
    		 Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase. Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF 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 participants while receiving Stribild in the randomized and extension phases.

    Serious adverse events
    		 Stribild PI+RTV+FTC/TDF All Stribild
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 293 (8.19%)
    11 / 140 (7.86%)
    24 / 313 (7.67%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         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
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         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 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Bipolar I disorder
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Drug abuse
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Acute myocardial infarction
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 293 (0.68%)
    0 / 140 (0.00%)
    2 / 313 (0.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 293 (0.34%)
    1 / 140 (0.71%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 293 (0.34%)
    1 / 140 (0.71%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile abscess
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 140 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Bronchitis
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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
    Rectal abscess
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 140 (0.71%)
    0 / 313 (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 PI+RTV+FTC/TDF All Stribild
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    169 / 293 (57.68%)
    67 / 140 (47.86%)
    169 / 313 (53.99%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 293 (8.19%)
    10 / 140 (7.14%)
    24 / 313 (7.67%)
         occurrences all number
    26
    10
    26
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    27 / 293 (9.22%)
    11 / 140 (7.86%)
    27 / 313 (8.63%)
         occurrences all number
    28
    11
    28
    Nausea
         subjects affected / exposed
    22 / 293 (7.51%)
    5 / 140 (3.57%)
    22 / 313 (7.03%)
         occurrences all number
    22
    5
    22
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    20 / 293 (6.83%)
    6 / 140 (4.29%)
    20 / 313 (6.39%)
         occurrences all number
    23
    6
    23
    Psychiatric disorders
    Depression
         subjects affected / exposed
    18 / 293 (6.14%)
    9 / 140 (6.43%)
    18 / 313 (5.75%)
         occurrences all number
    18
    9
    18
    Insomnia
         subjects affected / exposed
    13 / 293 (4.44%)
    8 / 140 (5.71%)
    13 / 313 (4.15%)
         occurrences all number
    14
    8
    14
    Anxiety
         subjects affected / exposed
    19 / 293 (6.48%)
    5 / 140 (3.57%)
    20 / 313 (6.39%)
         occurrences all number
    19
    5
    20
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    24 / 293 (8.19%)
    4 / 140 (2.86%)
    24 / 313 (7.67%)
         occurrences all number
    26
    4
    26
    Arthralgia
         subjects affected / exposed
    15 / 293 (5.12%)
    4 / 140 (2.86%)
    15 / 313 (4.79%)
         occurrences all number
    15
    4
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    39 / 293 (13.31%)
    20 / 140 (14.29%)
    39 / 313 (12.46%)
         occurrences all number
    49
    24
    49
    Upper respiratory tract inflammation
         subjects affected / exposed
    29 / 293 (9.90%)
    8 / 140 (5.71%)
    29 / 313 (9.27%)
         occurrences all number
    35
    11
    35
    Syphilis
         subjects affected / exposed
    20 / 293 (6.83%)
    6 / 140 (4.29%)
    20 / 313 (6.39%)
         occurrences all number
    24
    6
    24
    Sinusitis
         subjects affected / exposed
    15 / 293 (5.12%)
    6 / 140 (4.29%)
    16 / 313 (5.11%)
         occurrences all number
    17
    7
    18
    Gastroenteritis
         subjects affected / exposed
    11 / 293 (3.75%)
    7 / 140 (5.00%)
    11 / 313 (3.51%)
         occurrences all number
    12
    7
    13
    Pharyngitis
         subjects affected / exposed
    16 / 293 (5.46%)
    7 / 140 (5.00%)
    16 / 313 (5.11%)
         occurrences all number
    16
    7
    16

    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 and Study Procedures • 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 change estimated glomerular filtration rate (eGFR) entry criteriafrom ≥ 90 mL/min to ≥ 70 mL/min and to clarify that subjects could be rescreened withapproval from the medical monitor • Updated the screening visit procedures to align with the directive of Gilead’s DSPH group • Updated the overdose, safety, and pregnancy reporting requirements • Updated the definitions of childbearing potential and postmenopausal status • Updated the new contact information for DSPH and removed requirement to email safety event reports due to restrictive data privacy laws in some countries • Updated Section 7.4 to align with the new CT3 guidance • 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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