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    Clinical Trial Results:
    Continued Access to Darunavir/ritonavir (DRV/rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above

    Summary
    EudraCT number
    		 2017-000285-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2022
    First version publication date
    15 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114IFD3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01281813
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920, US Highway, Route 202, South Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, 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
    29 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to continue the provision of DRV/rtv to adult and pediatric subjects who previously received DRV/rtv in the adult (parent) studies C211 (2005-002486-36), C214 (2005-000594-22) , C229 (2007-001939-61) or in the pediatric (parent) Study trial TMC114-TiDP29-C232 (2009-017013-29) and who continued to benefit from the use of DRV/rtv, in countries where DRV was not commercially available for the subject, was not reimbursed, or could not be accessed through another source (example; access program, governmental program).
    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 Practices and applicable regulatory requirements. The safety evaluations included monitoring of adverse events, non-serious adverse events, serious adverse events, clinical laboratory tests, vital signs, electrocardiogram and physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 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
    Brazil: 1
    Country: Number of subjects enrolled
    Costa Rica: 7
    Country: Number of subjects enrolled
    Guatemala: 4
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Panama: 8
    Country: Number of subjects enrolled
    Thailand: 13
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    South Africa: 106
    Worldwide total number of subjects
    145
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    4
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    137
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who had completed treatment with DRV/rtv in adult parent trials TMC114-C211,TMC114-C214 ,TMC114-TiDP31-C229 or in pediatric (parent) trial TMC114-TiDP29-C232, who continued to benefit from use of DRV/rtv, who live in country where DRV is not accessible participated in this trial.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Children Less than (<)12 years
    Arm description
    		 HIV-1 infected children subjects received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir (DRV) 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg orally bid.

    Investigational medicinal product name
    DRV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    DRV 600 mg orally bid

    Investigational medicinal product name
    rtv 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    rtv 100 mg orally bid.

    Investigational medicinal product name
    Ritonavir (rtv) 32 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    rtv 32 mg orally bid.

    Arm title
    		 Adolescents (12-17 years)
    Arm description
    		 HIV-1 infected adolescent subjects received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRV 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DRV 800 mg (2 tablets of 400 mg) orally qd.

    Investigational medicinal product name
    rtv 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    rtv 100 mg tablets orally qd.

    Arm title
    		 Adults (greater than or equal to [>=] 18 years)
    Arm description
    		 HIV-1 infected adult subjects received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet and/or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (maximum exposure duration: up to 105 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRV 800 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DRV 800 mg (2 tablets of 400 mg) orally qd.

    Investigational medicinal product name
    rtv 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    rtv 100 mg tablet BID.

    Investigational medicinal product name
    DRV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DRV 600 mg tablet orally BID.

    Number of subjects in period 1
    		Children Less than (<)12 years Adolescents (12-17 years) Adults (greater than or equal to [>=] 18 years)
    Started
    4
    4
    137
    Completed
    0
    0
    0
    Not completed
    4
    4
    137
         Subject Reached A Virologic Endpoint
    -
    -
    5
         Consent withdrawn by subject
    -
    -
    13
         Sponsor's Decision
    4
    3
    7
         Adverse event, non-fatal
    -
    -
    10
         Subject Non-Compliant
    -
    -
    6
         Lost to follow-up
    -
    -
    31
         Switched to Commercially Available Medication
    -
    -
    26
         unspecified
    -
    1
    39

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Children Less than (<)12 years
    Reporting group description
    		 HIV-1 infected children subjects received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 HIV-1 infected adolescent subjects received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).

    Reporting group title
    Adults (greater than or equal to [>=] 18 years)
    Reporting group description
    		 HIV-1 infected adult subjects received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet and/or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (maximum exposure duration: up to 105 months).

    Reporting group values
    		 Children Less than (<)12 years Adolescents (12-17 years) Adults (greater than or equal to [>=] 18 years) Total
    Number of subjects
    		 4 4 137 145
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 4 0 0 4
        Adolescents (12-17 years)
    		 0 3 0 3
        Adults (18-64 years)
    		 0 1 136 137
        From 65-84 years
    		 0 0 1 1
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11 ± 0 13.8 ± 2.87 41.5 ± 8.6 -
    Sex: Female, Male
    Units: subjects
        Female
    		 1 2 82 85
        Male
    		 3 2 55 60
    Race/Ethnicity, Customised
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 18 18
        Black or African American
    		 4 4 91 99
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 0 0 6 6
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
        Hispanic
    		 0 0 18 18
        Other
    		 0 0 4 4
    Region of Enrollment
    Units: Subjects
        BRAZIL
    		 0 1 0 1
        COSTA RICA
    		 0 0 7 7
        GUATEMALA
    		 0 0 4 4
        MALAYSIA
    		 0 0 3 3
        PANAMA
    		 0 0 8 8
        SOUTH AFRICA
    		 4 3 99 106
        THAILAND
    		 0 0 13 13
        UKRAINE
    		 0 0 3 3

    End points

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    End points reporting groups
    Reporting group title
    Children Less than (<)12 years
    Reporting group description
    		 HIV-1 infected children subjects received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 HIV-1 infected adolescent subjects received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).

    Reporting group title
    Adults (greater than or equal to [>=] 18 years)
    Reporting group description
    		 HIV-1 infected adult subjects received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet and/or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (maximum exposure duration: up to 105 months).

    Primary: Number of Subjects with Serious Adverse Events

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    End point title
    		 Number of Subjects with Serious Adverse Events [1]
    End point description
    Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a subject or clinical investigation subjects administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death; was life threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect. Full analysis set (FAS) included all subjects who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
    End point type
    Primary
    End point timeframe
    Up to 9 years 11 months
    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 was done, no inferential statistical analysis was performed
    End point values
    		 Children Less than (<)12 years Adolescents (12-17 years) Adults (greater than or equal to [>=] 18 years)
    Number of subjects analysed
    4
    4
    137
    Units: subjects
    0
    1
    26
    No statistical analyses for this end point

    Primary: Number of Subjects with Adverse Events Leading to Study Drug Discontinuation

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    End point title
    		 Number of Subjects with Adverse Events Leading to Study Drug Discontinuation [2]
    End point description
    The AEs were defined as any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. FAS included all subjects who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
    End point type
    Primary
    End point timeframe
    Up to 9 years 11 months
    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: Descriptive statistics was done, no inferential statistical analysis was performed
    End point values
    		 Children Less than (<)12 years Adolescents (12-17 years) Adults (greater than or equal to [>=] 18 years)
    Number of subjects analysed
    4
    4
    137
    Units: subjects
    0
    0
    9
    No statistical analyses for this end point

    Primary: Number of Subjects with Adverse Events Possibly Related to Darunavir/ritonavir (DRV/rtv) Treatment

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    End point title
    		 Number of Subjects with Adverse Events Possibly Related to Darunavir/ritonavir (DRV/rtv) Treatment [3]
    End point description
    Number of subjects with adverse events possibly related to DRV/rtv treatment were reported in this endpoint. FAS included all subjects who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
    End point type
    Primary
    End point timeframe
    Up to 9 years 11 months
    Notes
    [3] - 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 was done, no inferential statistical analysis was performed
    End point values
    		 Children Less than (<)12 years Adolescents (12-17 years) Adults (greater than or equal to [>=] 18 years)
    Number of subjects analysed
    4
    4
    137
    Units: subjects
    0
    0
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 9 years 11 months
    Adverse event reporting additional description
    Full Analysis Set (FAS) included all subjects who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Children Less than (<)12 years
    Reporting group description
    		 HIV-1 infected children subjects received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).

    Reporting group title
    Adults (greater than or equal to [>=] 18 years)
    Reporting group description
    		 HIV-1 infected adult subjects received DRV 800 mg (2 tablets of 400 mg) orally qd along with rtv 100 mg tablet and/or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (maximum exposure duration: up to 105 months).

    Reporting group title
    Adolescents (12-17 years)
    Reporting group description
    		 HIV-1 infected adolescent subjects received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months)

    Serious adverse events
    		 Children Less than (<)12 years Adults (greater than or equal to [>=] 18 years) Adolescents (12-17 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    26 / 137 (18.98%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    3
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Threatened
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foetal Death
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Premature Baby
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Premature Labour
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Immature Respiratory System
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Acute Psychosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional Self-Injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 137 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foetal Exposure During Pregnancy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Maternal Exposure During Breast Feeding
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness Unilateral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Hepatobiliary disorders
    Jaundice Cholestatic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 137 (2.19%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bone Tuberculosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast Abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 137 (1.46%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 137 (0.73%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 137 (1.46%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Children Less than (<)12 years Adults (greater than or equal to [>=] 18 years) Adolescents (12-17 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 137 (2.92%)
    0 / 4 (0.00%)
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 137 (2.92%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2017
    -Clinical study protocol TMC114-TiDP29-C232 was integrated into protocol TMC114IFD3001, to allow subjects enrolled in Study TMC114-TiDP29-C232 to participate in Study TMC114IFD3001. - The name of the sponsor of the study was updated from ‘Tibotec Pharmaceuticals’ to ‘Janssen Research & Development’ because of the transition of the Johnson & Johnson Pharmaceutical Research & Development companies to a unified Janssen identity, as of 2 February 2012.
    20 Jun 2019
    The amendment was implemented to simplify the follow-up. DRV was approved in 2006 for use in adults and in 2011 for use in children as of the age of 3 years and, by June 2019, had already a well established safety profile. Hence, collection of additional data in Study TMC114IFD3001 was unlikely to provide substantial additional information on DRV or to impact the risk benefit assessment.

    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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