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    Clinical Trial Results:
    An open-label study to evaluate the safety, tolerability and pharmacokinetics of etravirine (ETR) in combination with other antiretrovirals (ARVs) in antiretroviral treatment experienced HIV-1 infected Subjects

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-023532-16
    Trial protocol
    		 RO  
    Global end of trial date
    11 Nov 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    26 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC125IFD3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01422330
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen R&D Ireland
    Sponsor organisation address
    Eastgate Village, Eastgate, Little Island, Co. Cork, Ireland,
    Public contact
    Clinical Registry Group, Janssen Research & Development, +353 21 4673500, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, +353 21 4673500, ClinicalTrialsEU@its.jnj.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
    11 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the safety, tolerability and pharmacokinetics of an Etravirine (ETR)-containing regimen without darunavir/ritonavir (DRV/rtv) over 48 weeks.
    Protection of trial subjects
    All Events of Special Interest were evaluated in conjunction with other systemic symptoms and laboratory abnormalities: information on time of onset, duration of events, time to resolution, concomitant therapies, and relationship to ETR and background regimen.
    Background therapy
    		 Antiretroviral other than Darunavir/Ritonavir
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Guatemala: 16
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Peru: 10
    Country: Number of subjects enrolled
    Puerto Rico: 3
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    United States: 35
    Country: Number of subjects enrolled
    South Africa: 108
    Worldwide total number of subjects
    211
    EEA total number of subjects
    15
    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)
    209
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 26 August 2011 - 11 November 2013.

    Pre-assignment
    Screening details
    		 A total of 528 participants were screened, of whom 211 participants were enrolled and treated with Etravirine.

    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
    		 Etravirine
    Arm description
    		 Participants administered with Etravirine 200 milligram (mg) twice daily in combination with an investigator-selected background regimen consisting of antiretroviral drug except Darunavir/Ritonavir.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etravirine
    Investigational medicinal product code
    JNJ-4371315
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Etravirine 200 mg tablet twice daily in combination with an investigator-selected background regimen consisting of antiretroviral drug except Darunavir/Ritonavir.

    Number of subjects in period 1
    		Etravirine
    Started
    211
    Completed
    165
    Not completed
    46
         Subject Reached A Virologic Endpoint
    11
         Sponsor's Decision
    2
         Adverse Event
    9
         Withdrawal By Subject
    8
         Subject Non-Compliant
    2
         Other
    2
         Subject Ineligible To Continue The Trial
    1
         Lost to follow-up
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etravirine
    Reporting group description
    		 Participants administered with Etravirine 200 milligram (mg) twice daily in combination with an investigator-selected background regimen consisting of antiretroviral drug except Darunavir/Ritonavir.

    Reporting group values
    		 Etravirine Total
    Number of subjects
    		 211 211
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 209 209
        From 65 to 84 years
    		 2 2
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.8 ( 10.06 ) -
    Title for Gender
    Units: subjects
        Female
    		 116 116
        Male
    		 95 95

    End points

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    End points reporting groups
    Reporting group title
    Etravirine
    Reporting group description
    		 Participants administered with Etravirine 200 milligram (mg) twice daily in combination with an investigator-selected background regimen consisting of antiretroviral drug except Darunavir/Ritonavir.

    Subject analysis set title
    Baseline Viral Load (copies/mL)<50
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants of ITT population having baseline viral load less than 50 copies/ml.

    Subject analysis set title
    Baseline Viral Load (copies/mL)>=50
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants of ITT population having baseline viral load greater than or equal to 50 copies/ml.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat (ITT) population included all participants who received at least 1 dose of Etravirine.

    Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    52 weeks
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Etravirine
    Number of subjects analysed
    211
    Units: Participants
    number (not applicable)
        AEs
    144
        SAEs
    11
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Virologic Response (<50 Copies/mL)at Week 48

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    End point title
    		 Percentage of Participants with Virologic Response (<50 Copies/mL)at Week 48
    End point description
    RNA (ribonucleic acid) copies/mL at Week 48 were analyzed as per FDA Snapshot approach. The FDA Snapshot approach is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/milliliter (observed case). Missing VL was considered as non-response. Virologic Failure includes participants who had VL greater than or equal to (>=50) copies/ml in the Week 48 window, participants who discontinued early due to lack or loss of efficacy, participants who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml , and participants who had a switch in background regimen that was not permitted by the protocol.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Baseline Viral Load (copies/mL)<50 Baseline Viral Load (copies/mL)>=50 Intent-to-treat (ITT) population
    Number of subjects analysed
    56
    155
    211
    Units: Percentage of Participant
    number (not applicable)
        Virologic success HIV RNA <50 copies/mL
    75
    47.7
    55
        Virologic failure
    12.5
    41.9
    34.1
        No viral load data
    12.5
    10.3
    10.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in Cluster of Differentiation 4 (CD4+) cell count at Week 48

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    End point title
    		 Change from Baseline in Cluster of Differentiation 4 (CD4+) cell count at Week 48
    End point description
    Change from baseline at Week 48 in CD4 cell count (cells/mm^6) was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and week 48
    End point values
    		 Baseline Viral Load (copies/mL)<50 Baseline Viral Load (copies/mL)>=50 Intent-to-treat (ITT) population
    Number of subjects analysed
    56
    155
    211
    Units: 10^6 cells/Liter
        arithmetic mean (standard error)
    32.4 ( 16.96 )
    64.6 ( 11.4 )
    56 ( 9.54 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Virologic Response (<400 Copies/mL)at Week 48

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    End point title
    		 Percentage of Participants with Virologic Response (<400 Copies/mL)at Week 48
    End point description
    RNA (ribonucleic acid) copies/mL at Week 48 were analyzed as per FDA Snapshot approach. The FDA Snapshot approach is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL< 400 copies/milliliter (observed case). Missing VL was considered as non-response. Virologic Failure includes participants who had VL greater than or equal to (>=400) copies/ml in the Week 48 window, participants who discontinued early due to lack or loss of efficacy, participants who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy and at the time of discontinuation had a VL>=400 copies/ml, and participants who had a switch in background regimen that was not permitted by the protocol.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Baseline Viral Load (copies/mL)<50 Baseline Viral Load (copies/mL)>=50 Intent-to-treat (ITT) population
    Number of subjects analysed
    56
    155
    211
    Units: Percentage of Participants
    number (not applicable)
        Virologic success HIV RNA <400 copies/mL
    82.1
    54.2
    61.6
        Virologic failure
    5.4
    34.2
    26.5
        No viral load data
    12.5
    11.6
    11.8
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC [0-12])

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC [0-12])
    End point description
    The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Baseline Viral Load (copies/mL)<50 Baseline Viral Load (copies/mL)>=50 Intent-to-treat (ITT) population
    Number of subjects analysed
    53
    146
    199
    Units: nanogram*hour per milliliter
        geometric mean (full range (min-max))
    5561.1 (366 to 38200)
    4637.8 (216 to 29400)
    4867.6 (216 to 38200)
    No statistical analyses for this end point

    Secondary: Pre-dose Plasma Concentration (C0H )

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    End point title
    		 Pre-dose Plasma Concentration (C0H )
    End point description
    The pre-dose plasma concentration is defined as the plasma concentration obtained before a dose is given.‘N’ (number of participants analyzed signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Baseline Viral Load (copies/mL)<50 Baseline Viral Load (copies/mL)>=50 Intent-to-treat (ITT) population
    Number of subjects analysed
    53
    146
    199
    Units: Nanogram per milliliter
        geometric mean (full range (min-max))
    333.5 (4 to 3080)
    279.8 (8 to 2330)
    293.2 (4 to 3080)
    No statistical analyses for this end point

    Secondary: Percentage of Virologic Failures With Emerging NNRTI Resistance Associated Mutations at Last Available On-Treatment Genotypic Data after Failure

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    End point title
    		 Percentage of Virologic Failures With Emerging NNRTI Resistance Associated Mutations at Last Available On-Treatment Genotypic Data after Failure
    End point description
    Virologic failure for resistance determination was defined as non-responder(at least 12 weeks on study, and never having had 2 consecutive plasma viral load <50 copies/mL)or rebounder(at least 12 weeks on study, and 2 consecutive plasma viral load >=50 copies/mL or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL). For this study, treatment-emergent mutations from a list of non-nucleoside reverse transcriptase (NNRTI) resistance-associated mutations (RAMs) (i.e. V90I, A98G, L100I, K101E, K101H, K101P,K101Q, K103H, K103N, K103S, K103T, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179D, V179E, V179F, V179G, V179I, V179L, V179T, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, V189I, G190A, G190C, G190E, G190Q, G190S, G190T, H221Y, P225H, F227C, F227L, M230I, M230L, P236L, K238N, K238T, and Y318F) occurring in at least 2 virologic failures are presented.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    49 [2]
    Units: Percentage of Participants
    number (not applicable)
        Any NNRTI RAM from list
    59.2
        Y181C
    36.7
        H221Y
    12.2
        E138A
    10.2
        M230L
    10.2
        E138K
    8.2
        V90I
    8.2
        E138Q
    6.1
        V179I
    6.1
        E138G
    4.1
        V108I
    4.1
        V189I
    4.1
    Notes
    [2] - Virologic Failure population
    No statistical analyses for this end point

    Secondary: ETR Fold Change for Virologic Failures at Baseline and Last Available On-Treatment Phenotypic Data after Failure

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    End point title
    		 ETR Fold Change for Virologic Failures at Baseline and Last Available On-Treatment Phenotypic Data after Failure
    End point description
    Virologic failure for resistance determination was defined as non-responder (at least 12 weeks on study, and never having had 2 consecutive plasma viral load <50 copies/mL) or rebounder (at least 12 weeks on study, and 2 consecutive plasma viral load >=50 copies/mL or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL). Fold change represents the phenotypic susceptibility of the participant’s HIV-1 virus to ETR as compared to the wild type HIV-1/IIIB virus.
    End point type
    Secondary
    End point timeframe
    48 Weeks
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    49 [3]
    Units: Participants
    median (full range (min-max))
        Baseline
    0.84 (0.39 to 39)
        Endpoint
    5.76 (0.5 to 276.72)
    Notes
    [3] - Virologic Failure population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 52 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    ETR 200 mg bid
    Reporting group description
    		 ETR 200 mg twice daily (b.i.d.) in combination with an investigator-selected background regimen

    Serious adverse events
    		 ETR 200 mg bid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 211 (5.21%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Eye injury
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 211 (0.47%)
         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
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ETR 200 mg bid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    144 / 211 (68.25%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 211 (1.90%)
         occurrences all number
    4
    Surgical and medical procedures
    Sinus operation
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    5 / 211 (2.37%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Malaise
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vaginal discharge
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Asthma
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Dry throat
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    7 / 211 (3.32%)
         occurrences all number
    7
    Nasal polyps
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Pleuritic pain
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Rhinitis seasonal
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Yawning
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Tonsillar inflammation
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Somnambulism
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Investigations
    Blood amylase increased
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Blood phosphorus decreased
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    3
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    International normalised ratio increased
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Prothrombin level increased
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Liver function test abnormal
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Accidental overdose
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Nerve injury
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Limb injury
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Humerus fracture
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Joint dislocation
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Joint sprain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Post-traumatic pain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Soft tissue injury
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Nervous system disorders
    Cerebral atrophy
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Cerebral infarction
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    7 / 211 (3.32%)
         occurrences all number
    7
    Neuropathy peripheral
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    9 / 211 (4.27%)
         occurrences all number
    15
    Lethargy
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Syncope
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Anaemia
         subjects affected / exposed
    4 / 211 (1.90%)
         occurrences all number
    4
    Macrocytosis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Pinguecula
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    4
    Abnormal faeces
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Breath odour
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    7 / 211 (3.32%)
         occurrences all number
    7
    Dry mouth
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    35 / 211 (16.59%)
         occurrences all number
    40
    Dental caries
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Food poisoning
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Peptic ulcer
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Mouth ulceration
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    7 / 211 (3.32%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    5 / 211 (2.37%)
         occurrences all number
    9
    Hepatic function abnormal
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Lipoatrophy
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    6 / 211 (2.84%)
         occurrences all number
    8
    Hyperhidrosis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Macule
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    7 / 211 (3.32%)
         occurrences all number
    9
    Rash macular
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Lipodystrophy acquired
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Rosacea
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Costochondritis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Osteoarthritis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Muscle spasms
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Bronchitis
         subjects affected / exposed
    13 / 211 (6.16%)
         occurrences all number
    14
    Acute tonsillitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    5 / 211 (2.37%)
         occurrences all number
    5
    Gingival abscess
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Furuncle
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 211 (1.90%)
         occurrences all number
    4
    Oral candidiasis
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Neurocysticercosis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    12 / 211 (5.69%)
         occurrences all number
    12
    Mastitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 211 (1.90%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    11 / 211 (5.21%)
         occurrences all number
    14
    Pseudocroup
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    3
    Otitis externa
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    9 / 211 (4.27%)
         occurrences all number
    9
    Pyelonephritis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    2
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 211 (8.06%)
         occurrences all number
    22
    Tonsillitis
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    3
    Strongyloidiasis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Syphilis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Tinea infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Viral rhinitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    11 / 211 (5.21%)
         occurrences all number
    12
    Vaginal infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Viral diarrhoea
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vulvitis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 211 (2.37%)
         occurrences all number
    5
    Dehydration
         subjects affected / exposed
    2 / 211 (0.95%)
         occurrences all number
    3
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 211 (1.42%)
         occurrences all number
    5
    Hyperglycaemia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    6 / 211 (2.84%)
         occurrences all number
    7
    Hyperuricaemia
         subjects affected / exposed
    4 / 211 (1.90%)
         occurrences all number
    6
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 211 (0.47%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2011
    It was created to specify the test used to measure plasma Volume, to add a pharmacokinetic substudy outlined in a separate document, and to add the collection of sparse samples to determine plasma concentrations and pharmacokinetics of the antiretroviral in the background regimen.
    02 Feb 2012
    The overall reason for this amendment was: Subjects with a plasma viral volume < 50 HIV-1 RNA copies/mL for which sensitivity to ETR and ARVs in the background regimen cannot be demonstrated, can be enrolled at the discretion of the investigator as guided by historical resistance testing or ARV treatment history. It was created to enhance adherence, by specifying that dispersion of ETR was allowed and that the choice of allowed liquids for ETR intake was broadened. Also, the name of the sponsor of the study changed from Tibotec Pharmaceuticals to Janssen R&D Ireland.

    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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