Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

    Summary
    EudraCT number
    		 2007-004736-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2016
    First version publication date
    09 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-183-0130
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00445146
    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 Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.
    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
    26 Feb 2007
    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
    Puerto Rico: 13
    Country: Number of subjects enrolled
    United States: 179
    Worldwide total number of subjects
    192
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    185
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.

    Pre-assignment
    Screening details
    		 Participants must have been enrolled in other Gilead-sponsored studies of EVG+RTV to be eligible to receive continued access to EVG+RTV in this study.

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

    Arms
    Arm title
    		 EVG+RTV
    Arm description
    		 Elvitegravir (EVG) boosted with ritonavir (RTV; r/) in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir
    Investigational medicinal product code
    Other name
    Vitekta®, GS-9137
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elvitegravir (EVG) 85 mg or 150 mg tablet administered orally once daily with food. Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen received EVG 85 mg and all other participants received EVG 150 mg. Some participants may have received EVG 300 mg during the course of protocol amendment 2.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food

    Number of subjects in period 1
    		EVG+RTV
    Started
    192
    Completed
    73
    Not completed
    119
         Adverse event, serious fatal
    3
         Withdrew Consent
    29
         Adverse event, non-fatal
    10
         Death
    9
         Investigator's Discretion
    22
         Pregnancy
    1
         Protocol Violation
    4
         Lost to follow-up
    13
         Lack of efficacy
    28

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 192 192
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 173 173
    Race
    Units: Subjects
        White
    		 139 139
        Black or African American
    		 48 48
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Other
    		 4 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 39 39
        Not Hispanic or Latino
    		 153 153

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    EVG+RTV
    Reporting group description
    		 Elvitegravir (EVG) boosted with ritonavir (RTV; r/) in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study

    Primary: Percentage of Participants Experiencing Any Treatment-Emergent Study Drug-Related Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Any Treatment-Emergent Study Drug-Related Adverse Event [1]
    End point description
    Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
    End point type
    Primary
    End point timeframe
    Up to Week 408 plus 30 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed.
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: percentage of participants
        number (not applicable)
    14.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Adverse Events
    End point description
    Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
    End point type
    Secondary
    End point timeframe
    Up to Week 408 plus 30 days
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: percentage of participants
    number (not applicable)
        Any AE
    93.8
        Grade 3 or 4 AE
    45.3
        Grade 3 or 4 Drug-related AE
    3.1
        Serious AE
    44.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Week 408 plus 30 days
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: percentage of participants
    number (not applicable)
        Grade 1
    18.3
        Grade 2
    31.9
        Grade 3
    35.1
        Grade 4
    14.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
    End point description
    A 'marked abnormality’ was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline. Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Week 408 plus 30 days
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: percentage of participants
        number (not applicable)
    40.3
    No statistical analyses for this end point

    Secondary: Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: g/dL
    arithmetic mean (standard deviation)
        Baseline (n = 190)
    14.2 ± 1.86
        Change at Week 24 (n = 165)
    0.1 ± 1.01
        Change at Week 48 (n = 151)
    0.3 ± 1.12
        Change at Week 96 (n = 139)
    0.2 ± 1.44
        Change at Week 144 (n = 118)
    0.2 ± 1.4
        Change at Week 192 (n = 106)
    0.3 ± 1.36
        Change at Week 240 (n = 91)
    0.2 ± 1.54
        Change at Week 288 (n = 84)
    0.3 ± 1.79
        Change at Week 336 (n = 78)
    0.3 ± 1.49
        Change at Week 384 (n = 70)
    0.4 ± 1.55
    No statistical analyses for this end point

    Secondary: Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: 10^6/μL
    arithmetic mean (standard deviation)
        Baseline (n = 190)
    4.6 ± 0.65
        Change at Week 24 (n = 165)
    0 ± 0.37
        Change at Week 48 (n = 151)
    0 ± 0.35
        Change at Week 96 (n = 139)
    0 ± 0.45
        Change at Week 144 (n = 118)
    0 ± 0.5
        Change at Week 192 (n = 106)
    0 ± 0.48
        Change at Week 240 (n = 91)
    0 ± 0.55
        Change at Week 288 (n = 84)
    0 ± 0.55
        Change at Week 336 (n = 78)
    0 ± 0.44
        Change at Week 384 (n = 70)
    0 ± 0.45
    No statistical analyses for this end point

    Secondary: White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: 10^3/μL
    arithmetic mean (standard deviation)
        Baseline (n = 190)
    5.64 ± 2.074
        Change at Week 24 (n = 165)
    0.02 ± 1.67
        Change at Week 48 (n = 151)
    0.12 ± 1.899
        Change at Week 96 (n = 139)
    -0.17 ± 1.761
        Change at Week 144 (n = 118)
    -0.25 ± 1.948
        Change at Week 192 (n = 106)
    -0.19 ± 2.072
        Change at Week 240 (n = 91)
    -0.09 ± 2.082
        Change at Week 288 (n = 84)
    -0.21 ± 2.091
        Change at Week 336 (n = 78)
    -0.35 ± 1.961
        Change at Week 384 (n = 70)
    -0.28 ± 1.759
    No statistical analyses for this end point

    Secondary: Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: 10^3/μL
    arithmetic mean (standard deviation)
        Baseline (n = 187)
    226 ± 75
        Change at Week 24 (n = 154)
    2 ± 47.3
        Change at Week 48 (n = 148)
    5 ± 49.5
        Change at Week 96 (n = 134)
    13 ± 59.4
        Change at Week 144 (n = 114)
    3 ± 48.7
        Change at Week 192 (n = 103)
    -2 ± 53.8
        Change at Week 240 (n = 88)
    6 ± 45.7
        Change at Week 288 (n = 80)
    6 ± 60.9
        Change at Week 336 (n = 76)
    -6 ± 61
        Change at Week 384 (n = 70)
    -15 ± 56.8
    No statistical analyses for this end point

    Secondary: Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (n = 192)
    101 ± 43.3
        Change at Week 24 (n = 170)
    -6 ± 26.8
        Change at Week 48 (n = 156)
    -9 ± 31
        Change at Week 96 (n = 143)
    -9 ± 28.9
        Change at Week 144 (n = 122)
    -13 ± 27.8
        Change at Week 192 (n = 110)
    -18 ± 27.7
        Change at Week 240 (n = 95)
    -17 ± 29.2
        Change at Week 288 (n = 86)
    -20 ± 29.3
        Change at Week 336 (n = 80)
    -19 ± 31.3
        Change at Week 384 (n = 72)
    -20 ± 33.5
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (n = 191)
    28 ± 16.6
        Change at Week 24 (n = 169)
    2 ± 16.3
        Change at Week 48 (n = 154)
    1 ± 17.5
        Change at Week 96 (n = 141)
    2 ± 19.4
        Change at Week 144 (n = 120)
    2 ± 18.6
        Change at Week 192 (n = 109)
    1 ± 16.2
        Change at Week 240 (n = 94)
    0 ± 18
        Change at Week 288 (n = 85)
    3 ± 17
        Change at Week 336 (n = 79)
    3 ± 22.9
        Change at Week 384 (n = 71)
    1 ± 15.9
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (n = 185)
    29 ± 14.5
        Change at Week 24 (n = 163)
    2 ± 13.4
        Change at Week 48 (n = 150)
    0 ± 13.5
        Change at Week 96 (n = 137)
    2 ± 16.2
        Change at Week 144 (n = 116)
    1 ± 14.5
        Change at Week 192 (n = 105)
    -1 ± 12.4
        Change at Week 240 (n = 91)
    0 ± 16.3
        Change at Week 288 (n = 82)
    1 ± 12.8
        Change at Week 336 (n = 76)
    1 ± 13.2
        Change at Week 384 (n = 68)
    1 ± 12
    No statistical analyses for this end point

    Secondary: HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: log10 copies/mL
    arithmetic mean (standard deviation)
        Baseline (n = 190)
    2.7 ± 1.337
        Change at Week 24 (n = 174)
    -0.13 ± 0.795
        Change at Week 48 (n = 158)
    -0.2 ± 0.892
        Change at Week 96 (n = 142)
    -0.11 ± 0.963
        Change at Week 144 (n = 123)
    -0.22 ± 0.998
        Change at Week 192 (n = 110)
    -0.21 ± 1.043
        Change at Week 240 (n = 96)
    -0.15 ± 0.955
        Change at Week 288 (n = 86)
    -0.34 ± 1.066
        Change at Week 336 (n = 82)
    -0.7 ± 1.055
        Change at Week 384 (n = 73)
    -0.68 ± 1.029
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Efficacy 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; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: percentage of participants
    number (not applicable)
        Baseline (n = 190)
    65.3
        Week 24 (n = 175)
    69.7
        Week 48 (n = 159)
    78.6
        Week 96 (n = 142)
    76.8
        Week 144 (n = 123)
    82.9
        Week 192 (n = 110)
    84.5
        Week 240 (n = 96)
    89.6
        Week 288 (n = 86)
    95.3
        Week 336 (n = 82)
    95.1
        Week 384 (n = 73)
    93.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Efficacy 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; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: percentage of participants
    number (not applicable)
        Baseline (n = 190)
    44.2
        Week 24 (n = 175)
    56
        Week 48 (n = 159)
    62.9
        Week 96 (n = 142)
    65.5
        Week 144 (n = 123)
    73.2
        Week 192 (n = 110)
    79.1
        Week 240 (n = 96)
    78.1
        Week 288 (n = 86)
    89.5
        Week 336 (n = 82)
    86.6
        Week 384 (n = 73)
    90.4
    No statistical analyses for this end point

    Secondary: CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    		 Close Top of page
    End point title
    		 CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point description
    Participants in the Efficacy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
    End point values
    		 EVG+RTV
    Number of subjects analysed
    191
    Units: cells/mm^3
    arithmetic mean (standard deviation)
        Baseline (n = 189)
    283 ± 211.8
        Change at Week 24 (n = 168)
    22 ± 98.9
        Change at Week 48 (n = 152)
    38 ± 119.5
        Change at Week 96 (n = 138)
    78 ± 132.3
        Change at Week 144 (n = 118)
    126 ± 177
        Change at Week 192 (n = 106)
    149 ± 167.5
        Change at Week 240 (n = 93)
    176 ± 198.1
        Change at Week 288 (n = 84)
    205 ± 210.8
        Change at Week 336 (n = 80)
    225 ± 206.8
        Change at Week 384 (n = 71)
    234 ± 214.4
    No statistical analyses for this end point

    Secondary: Incidence of Mortality

    		 Close Top of page
    End point title
    		 Incidence of Mortality
    End point description
    The percentage of participants who died was summarized.
    End point type
    Secondary
    End point timeframe
    Up to Week 408 plus 30 days
    End point values
    		 EVG+RTV
    Number of subjects analysed
    192
    Units: percentage of participants
        number (not applicable)
    6.8
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    EVG+RTV
    Reporting group description
    		 Elvitegravir (EVG) boosted with ritonavir (RTV; r/) in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study

    Serious adverse events
    		 EVG+RTV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    86 / 192 (44.79%)
         number of deaths (all causes)
    13
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    3 / 192 (1.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Castleman's disease
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    3 / 192 (1.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous stenosis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 192 (1.56%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Perforated ulcer
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Serum sickness-like reaction
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Chylothorax
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngeal ulceration
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    4 / 192 (2.08%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Toxicity to various agents
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    5 / 192 (2.60%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    4 / 192 (2.08%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    3 / 192 (1.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Aortic valve stenosis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Atrial flutter
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Necrotising retinitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Faecal incontinence
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intestinal prolapse
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 192 (2.60%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    4 / 192 (2.08%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    9 / 192 (4.69%)
         occurrences causally related to treatment / all
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    5 / 192 (2.60%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 192 (2.08%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 192 (1.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 192 (1.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Anal abscess
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cryptosporidiosis infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    HIV wasting syndrome
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Listeriosis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Prostatic abscess
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Secondary syphilis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis aspergillus
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Urethritis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral pericarditis
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 192 (2.08%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gout
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 192 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EVG+RTV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    172 / 192 (89.58%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    19 / 192 (9.90%)
         occurrences all number
    24
    Anogenital warts
         subjects affected / exposed
    16 / 192 (8.33%)
         occurrences all number
    21
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 192 (8.33%)
         occurrences all number
    18
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    29 / 192 (15.10%)
         occurrences all number
    34
    Pyrexia
         subjects affected / exposed
    17 / 192 (8.85%)
         occurrences all number
    23
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    10 / 192 (5.21%)
         occurrences all number
    11
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    14 / 192 (7.29%)
         occurrences all number
    14
    Benign prostatic hyperplasia
         subjects affected / exposed
    10 / 192 (5.21%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    33 / 192 (17.19%)
         occurrences all number
    42
    Oropharyngeal pain
         subjects affected / exposed
    14 / 192 (7.29%)
         occurrences all number
    22
    Rhinitis allergic
         subjects affected / exposed
    14 / 192 (7.29%)
         occurrences all number
    14
    Nasal congestion
         subjects affected / exposed
    13 / 192 (6.77%)
         occurrences all number
    19
    Dyspnoea
         subjects affected / exposed
    11 / 192 (5.73%)
         occurrences all number
    11
    Sinus congestion
         subjects affected / exposed
    11 / 192 (5.73%)
         occurrences all number
    15
    Psychiatric disorders
    Depression
         subjects affected / exposed
    34 / 192 (17.71%)
         occurrences all number
    41
    Insomnia
         subjects affected / exposed
    25 / 192 (13.02%)
         occurrences all number
    28
    Anxiety
         subjects affected / exposed
    22 / 192 (11.46%)
         occurrences all number
    27
    Investigations
    Weight decreased
         subjects affected / exposed
    14 / 192 (7.29%)
         occurrences all number
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 192 (12.50%)
         occurrences all number
    37
    Neuropathy peripheral
         subjects affected / exposed
    13 / 192 (6.77%)
         occurrences all number
    15
    Dizziness
         subjects affected / exposed
    10 / 192 (5.21%)
         occurrences all number
    13
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    17 / 192 (8.85%)
         occurrences all number
    22
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    49 / 192 (25.52%)
         occurrences all number
    73
    Nausea
         subjects affected / exposed
    32 / 192 (16.67%)
         occurrences all number
    46
    Gastrooesophageal reflux disease
         subjects affected / exposed
    22 / 192 (11.46%)
         occurrences all number
    22
    Vomiting
         subjects affected / exposed
    16 / 192 (8.33%)
         occurrences all number
    28
    Constipation
         subjects affected / exposed
    13 / 192 (6.77%)
         occurrences all number
    17
    Abdominal pain
         subjects affected / exposed
    12 / 192 (6.25%)
         occurrences all number
    18
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    15 / 192 (7.81%)
         occurrences all number
    18
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    11 / 192 (5.73%)
         occurrences all number
    12
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    33 / 192 (17.19%)
         occurrences all number
    40
    Arthralgia
         subjects affected / exposed
    26 / 192 (13.54%)
         occurrences all number
    36
    Pain in extremity
         subjects affected / exposed
    24 / 192 (12.50%)
         occurrences all number
    29
    Musculoskeletal pain
         subjects affected / exposed
    15 / 192 (7.81%)
         occurrences all number
    17
    Muscle spasms
         subjects affected / exposed
    13 / 192 (6.77%)
         occurrences all number
    19
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    62 / 192 (32.29%)
         occurrences all number
    121
    Sinusitis
         subjects affected / exposed
    50 / 192 (26.04%)
         occurrences all number
    74
    Bronchitis
         subjects affected / exposed
    40 / 192 (20.83%)
         occurrences all number
    90
    Nasopharyngitis
         subjects affected / exposed
    34 / 192 (17.71%)
         occurrences all number
    57
    Influenza
         subjects affected / exposed
    19 / 192 (9.90%)
         occurrences all number
    23
    Cellulitis
         subjects affected / exposed
    16 / 192 (8.33%)
         occurrences all number
    23
    Pharyngitis
         subjects affected / exposed
    15 / 192 (7.81%)
         occurrences all number
    19
    Urinary tract infection
         subjects affected / exposed
    15 / 192 (7.81%)
         occurrences all number
    20
    Folliculitis
         subjects affected / exposed
    12 / 192 (6.25%)
         occurrences all number
    14
    Otitis media
         subjects affected / exposed
    12 / 192 (6.25%)
         occurrences all number
    16
    Onychomycosis
         subjects affected / exposed
    11 / 192 (5.73%)
         occurrences all number
    14
    Viral infection
         subjects affected / exposed
    11 / 192 (5.73%)
         occurrences all number
    13
    Herpes simplex
         subjects affected / exposed
    10 / 192 (5.21%)
         occurrences all number
    12
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 192 (7.29%)
         occurrences all number
    15
    Hyperlipidaemia
         subjects affected / exposed
    10 / 192 (5.21%)
         occurrences all number
    10

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2007
    A substudy was added to the current study to evaluate the safety and pharmacokinetics of a higher dose of EVG+RTV (300 mg EVG and 100 mg RTV).
    09 Jun 2008
    The use of EVG 300 mg by participants in the substudy was discontinued due to the availability of data demonstrating the lack of utility for the 300-mg dose of EVG. Participants in the substudy were switched back to receiving EVG 150 mg. A Week 4 visit was added for additional safety monitoring of participants not treated with EVG in their prior study.

    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.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 06:52:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA