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    Clinical Trial Results:
    HIV Post-Exposure Prophylaxis with Darunavir/r (PEPDar)

    Summary
    EudraCT number
    		 2011-001303-13
    Trial protocol
    		 DE  
    Global end of trial date
    28 Sep 2013

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TMC114IFD3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01516970
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag G.m.b.H
    Sponsor organisation address
    Jonson & Johnson Platz 1, Neuss, 41470, Germany,
    Public contact
    Clinical Registry Group, Janssen-Cilag G.m.b.H, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag G.m.b.H, 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 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assesse the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Post exposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV infection status of the index person in Participants receiving HIV PEP for at least 28 days, and a maximum of 30 days.
    Protection of trial subjects
    Safety assessments included the monitoring of adverse events, clinical laboratory tests (Haematology, serum chemistry, and urinalysis), vital sign measurements, electrocardiogram (ECG) recordings, and performing physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 312
    Worldwide total number of subjects
    312
    EEA total number of subjects
    312
    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)
    312
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 324 Participants were screened, 305 were assigned to the per-protocol (PP) population, 310 to the Modified Intention-to-Treat (mITT) population and 312 to the Safety population.

    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
    		 Darunavir/Ritonavir PEP (DRV/r PEP)
    Arm description
    		 Darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    SUB23573
    Other name
    DARUNAVIR ETHANOLATE
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Darunavir 800 mg in combination with low-dose ritonavir (100 mg) administered orally once a day for at least 28 days and a maximum of 30 days.

    Investigational medicinal product name
    RITONAVIR
    Investigational medicinal product code
    SUB10342MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100 mg in combination with darunavir 800 mg administered orally once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs).

    Investigational medicinal product name
    LAMIVUDINE
    Investigational medicinal product code
    SUB08392MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The NRTIs (including lamivudine/zidovudine [Combivir]) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    ZIDOVUDINE
    Investigational medicinal product code
    SUB00153MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The NRTIs (including lamivudine/zidovudine [Combivir]) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Arm title
    		 Standard of care Postexposure Prophylaxis (SOCPEP)
    Arm description
    		 Standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. The NRTIs (tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) and LPV/r (Kaletra) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LOPINAVIR
    Investigational medicinal product code
    SUB02970MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lopinavir administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    RITONAVIR
    Investigational medicinal product code
    SUB10342MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    ZIDOVUDINE
    Investigational medicinal product code
    SUB00153MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Zidovudine administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    LAMIVUDINE
    Investigational medicinal product code
    SUB08392MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lamivudine administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    EFAVIRENZ
    Investigational medicinal product code
    SUB06463MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Efavirenz administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    EMTRICITABINE
    Investigational medicinal product code
    SUB01882MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Investigational medicinal product name
    TENOFOVIR DISOPROXIL FUMARATE
    Investigational medicinal product code
    SUB12607MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tenofovir disoproxil fumarate administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Number of subjects in period 1
    		Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP)
    Started
    159
    153
    Completed
    142
    132
    Not completed
    17
    21
         Consent withdrawn by subject
    1
    1
         Other
    8
    7
         Adverse event, serious non-fatal
    1
    5
         Lost to follow-up
    7
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Darunavir/Ritonavir PEP (DRV/r PEP)
    Reporting group description
    		 Darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Reporting group title
    Standard of care Postexposure Prophylaxis (SOCPEP)
    Reporting group description
    		 Standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. The NRTIs (tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) and LPV/r (Kaletra) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Reporting group values
    		 Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP) Total
    Number of subjects
    		 159 153 312
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 159 153 312
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.2 ( 9.2 ) 32.3 ( 9.33 ) -
    Title for Gender
    Units: subjects
        Female
    		 28 28 56
        Male
    		 131 125 256

    End points

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    End points reporting groups
    Reporting group title
    Darunavir/Ritonavir PEP (DRV/r PEP)
    Reporting group description
    		 Darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Reporting group title
    Standard of care Postexposure Prophylaxis (SOCPEP)
    Reporting group description
    		 Standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. The NRTIs (tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) and LPV/r (Kaletra) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.

    Subject analysis set title
    Per-Protocol (PP) Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol population (PP) was defined as all subjects in the mITT (modified intention-to-treat) population and who had received at least 1 dose of study medication.

    Subject analysis set title
    Modified Intention-to-Treat (mITT) Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population was defined as all subjects who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person.

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set included all participants who received at least one dose of randomized HIV PEP.

    Primary: Number of participants with early discontinuation from randomized human immunodeficiency virus postexposure prophylaxis (HIV PEP)

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    End point title
    		 Number of participants with early discontinuation from randomized human immunodeficiency virus postexposure prophylaxis (HIV PEP) [1]
    End point description
    Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days.
    End point type
    Primary
    End point timeframe
    Up to 30 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects analysed
    155 [2]
    150 [3]
    Units: participants
        number (confidence interval 95%)
    10 (3.5 to 11.5)
    15 (6.2 to 15.8)
    Notes
    [2] - PP
    [3] - PP
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events
    End point description
    A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 14-days treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and even if the event continued to be present.
    End point type
    Secondary
    End point timeframe
    Up to Month 3
    End point values
    		 Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects analysed
    159 [4]
    153 [5]
    Units: participants
        number (not applicable)
    131
    125
    Notes
    [4] - SAS
    [5] - SAS
    No statistical analyses for this end point

    Secondary: Changes from baseline in Patient reported outcome questionaire

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    End point title
    		 Changes from baseline in Patient reported outcome questionaire
    End point description
    Patient reported outcome (PRO) assessment of functional impairment in conjunction with HIV PEP in 3 inter-related domains (work, social life, and family life), as calculated from subject responses to the Sheehan Disability Scale (SDS) questionnaire.
    End point type
    Secondary
    End point timeframe
    Up to Month 3
    End point values
    		 Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects analysed
    159 [6]
    153 [7]
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Impairment in work/school/studies
    2.566 ( 2.775 )
    3.503 ( 2.891 )
        Impairment in social life
    2.465 ( 2.594 )
    3.464 ( 2.786 )
        Impairment in family life
    2.226 ( 2.624 )
    2.954 ( 2.713 )
        Overall
    6.987 ( 7.25 )
    9.451 ( 7.709 )
    Notes
    [6] - SAS
    [7] - SAS
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The statistical analysis between the two treatment groups was performed for the factors “Impairment in work/school/studies'' with Wilcoxon-Mann-Whitney test.
    Comparison groups
    Darunavir/Ritonavir PEP (DRV/r PEP) v Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0022
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The statistical analysis between the two treatment groups was performed for the factors “Impairment in social life'' with Wilcoxon-Mann-Whitney test.
    Comparison groups
    Darunavir/Ritonavir PEP (DRV/r PEP) v Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    The statistical analysis between the two treatment groups was performed for the factors “Impairment in family life'' with Wilcoxon-Mann-Whitney test.
    Comparison groups
    Darunavir/Ritonavir PEP (DRV/r PEP) v Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0071
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    The statistical analysis between the two treatment groups was performed for the factors “Overall'' with Wilcoxon-Mann-Whitney test.
    Comparison groups
    Darunavir/Ritonavir PEP (DRV/r PEP) v Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0017
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Percentage of participants who developed detectable HIV antibodies

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    End point title
    		 Percentage of participants who developed detectable HIV antibodies
    End point description
    Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 Darunavir/Ritonavir PEP (DRV/r PEP) Standard of care Postexposure Prophylaxis (SOCPEP)
    Number of subjects analysed
    155 [8]
    150 [9]
    Units: percentage
    number (not applicable)
        Negative
    99.3
    100
        Positive
    0.7
    0
    Notes
    [8] - PP
    [9] - PP
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Month 3
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Standard of care Postexposure Prophylaxis (SOCPEP)
    Reporting group description
    		 Comparator standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner.

    Reporting group title
    Darunavir/Ritonavir PEP (DRV/r PEP)
    Reporting group description
    		 DRV/r 800/100 mg q.d. with 2 NRTIs: darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs).

    Serious adverse events
    		 Standard of care Postexposure Prophylaxis (SOCPEP) Darunavir/Ritonavir PEP (DRV/r PEP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 159 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Standard of care Postexposure Prophylaxis (SOCPEP) Darunavir/Ritonavir PEP (DRV/r PEP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 153 (72.55%)
    96 / 159 (60.38%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 153 (1.31%)
    6 / 159 (3.77%)
         occurrences all number
    2
    6
    Dysgeusia
         subjects affected / exposed
    5 / 153 (3.27%)
    1 / 159 (0.63%)
         occurrences all number
    5
    1
    Headache
         subjects affected / exposed
    8 / 153 (5.23%)
    19 / 159 (11.95%)
         occurrences all number
    8
    21
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 153 (0.65%)
    5 / 159 (3.14%)
         occurrences all number
    1
    5
    Fatigue
         subjects affected / exposed
    28 / 153 (18.30%)
    21 / 159 (13.21%)
         occurrences all number
    28
    21
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    11 / 153 (7.19%)
    14 / 159 (8.81%)
         occurrences all number
    13
    14
    Diarrhoea
         subjects affected / exposed
    76 / 153 (49.67%)
    45 / 159 (28.30%)
         occurrences all number
    80
    46
    Flatulence
         subjects affected / exposed
    11 / 153 (7.19%)
    5 / 159 (3.14%)
         occurrences all number
    11
    5
    Nausea
         subjects affected / exposed
    41 / 153 (26.80%)
    24 / 159 (15.09%)
         occurrences all number
    42
    26
    Vomiting
         subjects affected / exposed
    9 / 153 (5.88%)
    10 / 159 (6.29%)
         occurrences all number
    9
    11
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 153 (2.61%)
    7 / 159 (4.40%)
         occurrences all number
    5
    7
    Psychiatric disorders
    Sleep Disorder
         subjects affected / exposed
    6 / 153 (3.92%)
    0 / 159 (0.00%)
         occurrences all number
    6
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    4 / 153 (2.61%)
    5 / 159 (3.14%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2011
    The overall reason for the amendment was to include participants with nonoccupational event with documented or potential for HIV exposure. Clarification about duration of treatment and drug accountability was only recorded for DRV/r, inclusion of stratification by exposure type due to the inclusion of subjects with non-occupational exposure, and clarification of statistical analysis in case of premature study termination, deletion of safety evaluations not relevant to the study, and reference to SmPC for Prezista deleted.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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