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    Clinical Trial Results:
    A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects

    Summary
    EudraCT number
    		 2015-002711-15
    Trial protocol
    		 GB   DE   ES   IT  
    Global end of trial date
    24 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2018
    First version publication date
    29 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-1823
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02605954
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center , Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center , Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    24 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.
    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 2015
    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
    United States: 56
    Country: Number of subjects enrolled
    Italy: 59
    Country: Number of subjects enrolled
    Spain: 86
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 63
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    275
    EEA total number of subjects
    219
    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)
    247
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe and North America. The first participant was screened on 18 November 2015. The last study visit occurred on 24 Jan 2018.

    Pre-assignment
    Screening details
    		 346 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E/C/F/TAF
    Arm description
    		 Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    E/C/F/TAF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg administered once daily with food for 48 weeks

    Arm title
    		 ABC/3TC+3rd Agent
    Arm description
    		 Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Abacavir/lamivudine
    Investigational medicinal product code
    Other name
    ABC/3TC, Epzicom, Kivexa
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/300 mg plus a third antiretroviral agent administered orally once daily for 24 weeks

    Number of subjects in period 1 [1]
    		E/C/F/TAF ABC/3TC+3rd Agent
    Started
    183
    91
    Completed
    171
    88
    Not completed
    12
    3
         Withdrew Consent
    2
    2
         Non-Compliance with Study Drug
    1
    -
         Adverse event, non-fatal
    5
    1
         Lost to Follow-up
    3
    -
         Investigator's Discretion
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was randomized/enrolled but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks

    Reporting group title
    ABC/3TC+3rd Agent
    Reporting group description
    		 Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC

    Reporting group values
    		 E/C/F/TAF ABC/3TC+3rd Agent Total
    Number of subjects
    		 183 91 274
    Age categorical
    Units: Subjects
    Age continuous
    Safety Analysis Set: participants who took at least 1 dose of E/C/F/TAF or ABC/3TC+3rd Agent (on or after Day 1).
    Units: years
        arithmetic mean (standard deviation)
    		 50 ± 11.6 49 ± 10.7 -
    Gender categorical
    Units: Subjects
        Female
    		 27 17 44
        Male
    		 156 74 230
    Race
    Units: Subjects
        Asian
    		 5 1 6
        Black
    		 27 15 42
        White
    		 150 75 225
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 27 16 43
        Not Hispanic or Latino
    		 155 73 228
        Not Permitted
    		 1 2 3
    HIV-1 RNA Categories
    Units: Subjects
        < 50 copies/mL
    		 177 91 268
        50 ≥ copies/mL
    		 6 0 6
    CD4 Cell Count Category
    Units: Subjects
        ≥ 50 to < 200 cells/µL
    		 2 0 2
        ≥ 200 to < 350 cells/µL
    		 11 7 18
        ≥ 350 to < 500 cells/µL
    		 30 13 43
        ≥ 500 cells/µL
    		 140 71 211
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 701 ± 280.1 753 ± 312.8 -

    End points

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    End points reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks

    Reporting group title
    ABC/3TC+3rd Agent
    Reporting group description
    		 Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC

    Subject analysis set title
    Delayed E/C/F/TAF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food

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

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    End point title
    		 Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24
    End point description
    • The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. • Full Analysis Set: participants who were randomized and received at least one dose of study drug (either E/C/F/TAF or ABC/3TC+3rd agent on or after Day 1).
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 E/C/F/TAF ABC/3TC+3rd Agent Delayed E/C/F/TAF
    Number of subjects analysed
    183
    91
    89
    Units: percentage of participants
        number (not applicable)
    93.4
    97.8
    96.6
    Statistical analysis title
    		 Stats Analysis – E/C/F/TAF vs ABC/3TC+3rd agent
    Comparison groups
    E/C/F/TAF v ABC/3TC+3rd Agent
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.15
    Method
    		 Fisher exact
    Parameter type
    		 Difference in Percentages
    Point estimate
    -4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 1.9
    Notes
    [1] - With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with > 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.

    Secondary: Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12

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    End point title
    		 Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12
    End point description
    • The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. • Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 E/C/F/TAF ABC/3TC+3rd Agent Delayed E/C/F/TAF
    Number of subjects analysed
    183
    91
    89
    Units: percentage of participants
        number (not applicable)
    95.1
    98.9
    96.6
    Statistical analysis title
    		 Stats Analysis – E/C/F/TAF vs ABC/3TC+3rd agent
    Comparison groups
    E/C/F/TAF v ABC/3TC+3rd Agent
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.17
    Method
    		 Fisher exact
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 1.6
    Notes
    [2] - With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with > 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.

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

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    End point title
    		 Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48 [3]
    End point description
    • The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. • Only the participants who were randomized to E/C/F/TAF group were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants who were randomized to E/C/F/TAF group were analyzed.
    End point values
    		 E/C/F/TAF
    Number of subjects analysed
    183
    Units: percentage of participants
        number (not applicable)
    86.9
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF ABC/3TC+3rd Agent Delayed E/C/F/TAF
    Number of subjects analysed
    169
    90
    86
    Units: cells/µL
        arithmetic mean (standard deviation)
    -28 ± 161.4
    8 ± 192.9
    -23 ± 201.7
    Statistical analysis title
    		 Stats Analysis – E/C/F/TAF vs ABC/3TC+3rd agent
    Comparison groups
    E/C/F/TAF v ABC/3TC+3rd Agent
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.11
    Method
    		 ANOVA
    Parameter type
    		 Difference in least square mean
    Point estimate
    -36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -80
         upper limit
    		 9

    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 [4]
    End point description
    Participants in the E/C/F/TAF group with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only the participants who were randomized to E/C/F/TAF group were analyzed.
    End point values
    		 E/C/F/TAF
    Number of subjects analysed
    156
    Units: cells/µL
        arithmetic mean (standard deviation)
    -32 ± 147.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks plus 30 days
    Adverse event reporting additional description
    The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: • E/C/F/TAF group = 48 weeks plus 30 days • ABC/3TC+3rd Agent = 24 weeks • Delayed E/C/F/TAF group = 24 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks

    Reporting group title
    ABC/3TC+3rd Agent
    Reporting group description
    		 ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC

    Reporting group title
    Delayed E/C/F/TAF
    Reporting group description
    		 Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.

    Reporting group title
    All E/C/F/TAF
    Reporting group description
    		 Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF. Participants received E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food.

    Serious adverse events
    		 E/C/F/TAF ABC/3TC+3rd Agent Delayed E/C/F/TAF All E/C/F/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 183 (6.56%)
    1 / 91 (1.10%)
    4 / 89 (4.49%)
    16 / 272 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    2 / 272 (0.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    2 / 272 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 272 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 E/C/F/TAF ABC/3TC+3rd Agent Delayed E/C/F/TAF All E/C/F/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 183 (38.80%)
    21 / 91 (23.08%)
    17 / 89 (19.10%)
    88 / 272 (32.35%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 183 (8.20%)
    4 / 91 (4.40%)
    4 / 89 (4.49%)
    19 / 272 (6.99%)
         occurrences all number
    21
    5
    4
    25
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 183 (5.46%)
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    10 / 272 (3.68%)
         occurrences all number
    10
    1
    0
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    19 / 183 (10.38%)
    3 / 91 (3.30%)
    4 / 89 (4.49%)
    23 / 272 (8.46%)
         occurrences all number
    22
    4
    4
    26
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 183 (6.01%)
    2 / 91 (2.20%)
    8 / 89 (8.99%)
    19 / 272 (6.99%)
         occurrences all number
    11
    2
    8
    19
    Back pain
         subjects affected / exposed
    6 / 183 (3.28%)
    6 / 91 (6.59%)
    2 / 89 (2.25%)
    8 / 272 (2.94%)
         occurrences all number
    6
    6
    2
    8
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 183 (6.56%)
    5 / 91 (5.49%)
    1 / 89 (1.12%)
    13 / 272 (4.78%)
         occurrences all number
    14
    5
    1
    15
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    13 / 183 (7.10%)
    6 / 91 (6.59%)
    0 / 89 (0.00%)
    13 / 272 (4.78%)
         occurrences all number
    13
    6
    0
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jun 2016
    Eligibility criteria updated to allow additional participants to enroll in the study without changing the overall risk/benefit ratio.

    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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