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    Clinical Trial Results:
    An Open-Label Study with TMC278 25 mg q.d. in Combination with a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in HIV-1 Infected Subjects, Who Participated in TMC278 clinical studies

    Summary
    EudraCT number
    		 2010-021209-18
    Trial protocol
    		 BE   DE   GB   SE   ES   IT   DK   AT   NL  
    Global end of trial date
    28 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2021
    First version publication date
    26 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC278-TiDP6-C222
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01266902
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Janssen Research & Development, LLC, Clinical Registry group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research & Development, LLC, Clinical Registry group, 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
    28 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to provide continued access to rilpivirine (RPV) for subjects who were randomized and treated with RPV in the Phase 2b (TMC278-C204 [C204]) or Phase 3 studies (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]), and who, at the time of roll-over, experienced and were expected to continue experiencing clinical benefit from RPV treatment.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice (GCP) and applicable regulatory requirements. Serious Adverse Events (SAEs), Adverse events (AEs) leading to discontinuation, any grade 3/4 events of rash (irrespective of causality), AEs considered at least possibly related to RPV, human immunodeficiency virus (HIV)-related AEs, and pregnancies were collected from signing of the informed consent form (ICF) until the data cut-off date and were followed up by the investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 9 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 35
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Chile: 12
    Country: Number of subjects enrolled
    China: 26
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Thailand: 65
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 85
    Country: Number of subjects enrolled
    South Africa: 48
    Worldwide total number of subjects
    482
    EEA total number of subjects
    107
    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)
    479
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total of 482 subjects were treated and 437 discontinued at data cut-off date (8 Feb 2018): 371 switched to commercially available RPV and 6 discontinued as they reached a virologic endpoint. At last visit of last subject (28 February 2020), out of 45 subjects 37 switched to commercially available RPV and 6 lost to follow-up.

    Period 1
    Period 1 title
    Period 1 (Main Study)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rilpivirine (RPV) (TMC278-C204 [C204])
    Arm description
    		 Subjects who rolled over from trial C204 continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    TMC278
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RPV 25 mg oral tablets were administered orally.

    Investigational medicinal product name
    Nucleos(t)ide Reverse Transcriptase Inhibitors
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two N(t)RTIs were administered as the investigator-selected background regimen.

    Arm title
    		 RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Arm description
    		 Subjects who rolled over from trial C209 and C215 continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nucleos(t)ide Reverse Transcriptase Inhibitors
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two N(t)RTIs were administered as the investigator-selected background regimen.

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    TMC278
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RPV 25 mg oral tablets were administered orally.

    Number of subjects in period 1
    		Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Started
    119
    363
    Completed
    89
    282
    Not completed
    30
    81
         Consent withdrawn by subject
    2
    12
         Adverse events
    3
    11
         Continued to RPV treatment
    11
    34
         Investigator's/Subject's decision
    2
    3
         Subject non-compliant
    3
    7
         Lost to follow-up
    5
    12
         Lack of efficacy
    4
    2
    Period 2
    Period 2 title
    Period 2 (After Protocol Amendment 3)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Arm title
    		 RPV 25 mg (After Protocol Amendment 3)
    Arm description
    		 All subjects who were continued under a simplified study setting with only a minimum of study-related activities, as per Protocol Amendment 3 continued to receive RPV 25 mg and followed up for safety.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    TMC278
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RPV 25 mg oral tablets were administered orally.

    Number of subjects in period 2 [1]
    		RPV 25 mg (After Protocol Amendment 3)
    Started
    45
    Completed
    37
    Not completed
    8
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
         Lost to follow-up
    6
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 45 subjects continued Rilpivirine (RPV) treatment per Protocol Amendment 3.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rilpivirine (RPV) (TMC278-C204 [C204])
    Reporting group description
    		 Subjects who rolled over from trial C204 continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.

    Reporting group title
    RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Reporting group description
    		 Subjects who rolled over from trial C209 and C215 continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.

    Reporting group values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) Total
    Number of subjects
    		 119 363 482
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 118 361 479
        From 65 to 84 years
    		 1 2 3
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    		 40 (28 to 66) 39 (22 to 69) -
    Title for Gender
    Units: subjects
        Female
    		 41 84 125
        Male
    		 78 279 357

    End points

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    End points reporting groups
    Reporting group title
    Rilpivirine (RPV) (TMC278-C204 [C204])
    Reporting group description
    		 Subjects who rolled over from trial C204 continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.

    Reporting group title
    RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Reporting group description
    		 Subjects who rolled over from trial C209 and C215 continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.
    Reporting group title
    RPV 25 mg (After Protocol Amendment 3)
    Reporting group description
    		 All subjects who were continued under a simplified study setting with only a minimum of study-related activities, as per Protocol Amendment 3 continued to receive RPV 25 mg and followed up for safety.

    Primary: Number of Subjects with Adverse Events (AEs)

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    End point title
    		 Number of Subjects with Adverse Events (AEs) [1]
    End point description
    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. The intent-to-treat (ITT) population included all subjects who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    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 Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: Subjects
    32
    70
    No statistical analyses for this end point

    Primary: Number of Subjects with Grade 3/4 Events of Rash irrespective of Causality

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    End point title
    		 Number of Subjects with Grade 3/4 Events of Rash irrespective of Causality [2]
    End point description
    Subjects with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2*baseline value and at least 5 times upper limit of normal; fever greater than (>) 38 degree celsius or 100 degree fahrenheit; eosinophils > 1000/millimeter (mm)^3; serum sickness-like reaction. A grade 4 rash defined as following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    Notes
    [2] - 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 Inferential statistical analysis was planned for the Primary Endpoint.
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Time to Virologic Rebound

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    End point title
    		 Time to Virologic Rebound
    End point description
    Time to virologic rebound was time to (first) human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (>=) 50 or >= 200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Secondary
    End point timeframe
    Up to Week 360
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: days
    arithmetic mean (standard error)
        >= 50 copies/mL
    1670.6 ± 51.32
    1939.3 ± 52.43
        >= 200 copies/mL
    1901.3 ± 47.19
    1877.3 ± 25.93
    No statistical analyses for this end point

    Secondary: Time To Treatment Failure

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    End point title
    		 Time To Treatment Failure
    End point description
    Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA >= 50 or >= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Secondary
    End point timeframe
    Up to Week 360
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: days
    arithmetic mean (standard error)
        >= 50 copies/mL
    1795.7 ± 70.03
    1694.1 ± 59.42
        >= 200 copies/mL
    1868.7 ± 63.29
    1637.5 ± 42.42
    No statistical analyses for this end point

    Secondary: Change from Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach until Week 336

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    End point title
    		 Change from Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach until Week 336
    End point description
    Change from baseline in CD4+ cell count were reported for observed case approach. The immunologic assessment was determined by changes in Cluster of CD4+ cell count for observed case approach. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'n' (number analyzed) included all subjects who were evaluable for specified time point categories.
    End point type
    Secondary
    End point timeframe
    Baseline up to Weeks 96, 192, 288, 336
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: cells/microliter (cells/mcL)
    arithmetic mean (standard error)
        Week 96: Observed Case (n= 74, 149)
    72.63 ± 20.581
    55.91 ± 13.425
        Week 192: Observed Case (n= 68, 100)
    148.76 ± 24.111
    132.73 ± 21.989
        Week 288: Observed Case (n= 45, 89)
    122.29 ± 29.628
    101.50 ± 24.108
        Week 336: Observed Case (n= 12, 30)
    161.73 ± 39.851
    76.49 ± 40.484
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach until Week 336

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    End point title
    		 Change from Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach until Week 336
    End point description
    Change from baseline in CD4+ cell count were reported for NC=F approach (subjects who discontinued because RPV became commercially available or could be accessed through another source or because the subjects switched to other local [RPV-based] treatment options or local standard of care, were censored at that time; other subjects after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach). The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regime. Here 'n' (number analyzed) included all subjects who were evaluable for specified time point categories.
    End point type
    Secondary
    End point timeframe
    Baseline up to weeks 96, 192, 288, 336
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: cells/mcL
    arithmetic mean (standard error)
        Week 96 (n= 79, 196)
    69.76 ± 19.372
    42.19 ± 11.525
        Week 192 (n= 77, 153)
    133.56 ± 21.906
    91.69 ± 15.563
        Week 288 (n= 61, 134)
    92.12 ± 22.809
    63.33 ± 17.132
        Week 336 (n= 27, 86)
    70.69 ± 23.558
    49.24 ± 16.688
    No statistical analyses for this end point

    Secondary: Number of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects with Serious Adverse Events (SAEs)
    End point description
    A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Secondary
    End point timeframe
    Up to 7 years
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: Subjects
    9
    14
    No statistical analyses for this end point

    Secondary: Number of Subjects with AEs related to Rilpivirine (RPV)

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    End point title
    		 Number of Subjects with AEs related to Rilpivirine (RPV)
    End point description
    Number of subjects with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. The ITT population included all subjects who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
    End point type
    Secondary
    End point timeframe
    Up to 7 years
    End point values
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Number of subjects analysed
    119
    363
    Units: Subjects
    7
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 years
    Adverse event reporting additional description
    The safety analysis set included all subjects who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimen.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Rilpivirine (RPV) (TMC278-C204 [C204])
    Reporting group description
    		 Subjects who rolled over from trial C204 continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1.

    Reporting group title
    RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Reporting group description
    		 Subjects who rolled over from trial C209 and C215 continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.

    Serious adverse events
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 119 (7.56%)
    14 / 363 (3.86%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal Adenoma
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose Vein
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Glucose Increased
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab Wound
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Hypertrophy
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rilpivirine (RPV) (TMC278-C204 [C204]) RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 119 (20.17%)
    61 / 363 (16.80%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital Warts
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    2 / 119 (1.68%)
    0 / 363 (0.00%)
         occurrences all number
    2
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 119 (0.00%)
    7 / 363 (1.93%)
         occurrences all number
    0
    7
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    1
    Chest Pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Feeling Hot
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Nodule
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Oedema Peripheral
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Nasal Congestion
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Productive Cough
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Abnormal Dreams
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 119 (0.84%)
    3 / 363 (0.83%)
         occurrences all number
    1
    4
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    2
    Blood Cholesterol Increased
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Blood Lactic Acid Increased
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Blood Triglycerides Increased
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Liver Function Test Abnormal
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Bone Fissure
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Injury
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Joint Injury
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Skin Injury
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Cluster Headache
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Disturbance in Attention
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    0 / 119 (0.00%)
    4 / 363 (1.10%)
         occurrences all number
    0
    4
    Paraesthesia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Eye Pain
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Abdominal Pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 119 (0.84%)
    2 / 363 (0.55%)
         occurrences all number
    1
    3
    Anal Pruritus
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Enteritis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    1
    Gingivitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Dermal Cyst
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Dermatitis Allergic
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    3
    Dyshidrosis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Facial Wasting
         subjects affected / exposed
    2 / 119 (1.68%)
    0 / 363 (0.00%)
         occurrences all number
    2
    0
    Lipoatrophy
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    1
    Lipodystrophy Acquired
         subjects affected / exposed
    2 / 119 (1.68%)
    0 / 363 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic Dermatitis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Skin Plaque
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Osteopenia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Trismus
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Infections and infestations
    Body Tinea
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    2
    0
    Chlamydial Infection
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    1
    Dengue Fever
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Eye Infection Toxoplasmal
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Fungal Infection
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Genital Herpes
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Hepatitis C
         subjects affected / exposed
    2 / 119 (1.68%)
    0 / 363 (0.00%)
         occurrences all number
    2
    0
    Herpes Simplex
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    1
    Herpes Zoster
         subjects affected / exposed
    1 / 119 (0.84%)
    2 / 363 (0.55%)
         occurrences all number
    2
    2
    Hordeolum
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Latent Tuberculosis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Lymph Node Tuberculosis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 363 (0.55%)
         occurrences all number
    0
    2
    Oral Herpes
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Otitis Externa
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Otitis Media
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Perineal Abscess
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Periorbital Cellulitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Syphilis
         subjects affected / exposed
    2 / 119 (1.68%)
    2 / 363 (0.55%)
         occurrences all number
    3
    2
    Tonsillitis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Urinary Tract Infection
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Diabetes Mellitus
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 363 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    3
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 363 (0.28%)
         occurrences all number
    1
    3
    Hyperuricaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1
    Vitamin D Deficiency
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 363 (0.28%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2011
    Amendment 1, issued on 5 May 2011, was considered substantial and the overall reason for the amendment was to replace the serum pregnancy test by a urine pregnancy test, add a reminder for the human leukocyte antigen (HLA)-B*5701 allele testing and viral genotype determination, switching of background nucleos(t)ide reverse transcriptase inhibitors [N(t)RTI]s from the roll-over visit onwards was allowed, effective methods of birth control for male and female subjects were updated and the withdrawal criteria were updated.
    28 Nov 2016
    Amendment 3, issued on 28 November 2016 (with country-specific amendments in South Africa and Chile [25 July 2017]), was considered substantial and the overall reason for the amendment was the simplification of the study and the reduction of study-related activities to a minimum for the limited number of subjects remaining in this study. The main component of the study remained to allow subjects who experienced and were expected to continue experiencing clinical benefit from rilpivirine (RPV) treatment to have continued access to RPV in a simplified study setting or to be switched to local (RPV-based) treatment options or local standard of care, as appropriate.

    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.
    Not all AEs were collected; AEs considered related to RPV, leading to discontinuations, SAEs, or grade 3/4 events of rash regardless of causality were collected; discontinuation rate was > 90 percent which makes interpretation of results difficult.
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    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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