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    Clinical Trial Results:
    COMPARISON OF TWO ANTIRETROVIRAL ALTERNATIVE COMBINATIONS IN HIV-1 POST-EXPOSURE PROPHYLAXIS: TENOFOVIR+EMTRICITABINE (TRUVADA®) + LOPINAVIR/RITONAVIR (KALETRA®) VS TENOFOVIR+EMTRICITABINA+ COBICISTAT + ELVITEGRAVIR (STRIBILD®). A PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY (STRIB-PEP)

    Summary
    EudraCT number
    		 2014-001193-34
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Sep 2025
    First version publication date
    12 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    STRIB-PEP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02198443
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per a la Recerca Biomèdica
    Sponsor organisation address
    Rosselló 149, Barcelona, Spain,
    Public contact
    Anna Cruceta, CTU clinical Trial unit- hospital clinic Barcelona, +34 9322754004380, acruceta@recerca.clinic.cat
    Scientific contact
    Anna Cruceta, CTU clinical Trial unit- hospital clinic Barcelona, +34 9322754004380, acruceta@recerca.clinic.cat
    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
    15 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the rate of dropouts from a new pattern of prophylaxis (PEP) post-exposure HIV with a guideline classic 28 days of treatment.
    Protection of trial subjects
    The STRIBPEP clinical trial was conducted in accordance with the Declaration of Helsinki and Spanish legislation (Real Decreto 223/2004). All participants provided written informed consent after receiving clear, understandable information. Confidentiality of personal data was strictly maintained, and subjects were identified only by study codes. The study was approved by the relevant ethics committee and regulatory authorities, and participants retained the right to withdraw at any time without prejudice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2015
    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
    Spain: 157
    Worldwide total number of subjects
    157
    EEA total number of subjects
    157
    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)
    157
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at the emergency department of Hospital Clínic de Barcelona following potential non-occupational exposure to HIV. A total of 594 individuals were assessed for eligibility, and 157 were randomized after meeting inclusion criteria based on national guidelines.

    Pre-assignment
    Screening details
    		 Screening included baseline clinical evaluation and laboratory tests performed within the first 10 days post-exposure. Randomization and treatment initiation occurred immediately after eligibility confirmation. Patients received counselling and prophylaxis for other STIs as per national guidelines.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elvitegravir/cobicistat
    Arm description
    		 Participants received a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®) once daily for 28 days as post-exposure prophylaxis (PEP) for HIV-1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir+Emtricitabina+Cobicistat+Elvitegravir
    Investigational medicinal product code
    Other name
    Stribild®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 245 mg tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 136 mg tenofovir). Administered orally, once daily.

    Arm title
    		 Lopinavir/ritonavir
    Arm description
    		 Participants received lopinavir/ritonavir (Kaletra®) twice daily plus emtricitabine/tenofovir disoproxil fumarate (Truvada®) once daily for 28 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lopinavir + Ritonavir + Emtricitabine + Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Kaletra®, Truvada®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lopinavir/ritonavir (Kaletra®) 400/100 mg twice daily (2 tablets of 200/50 mg), plus emtricitabine/tenofovir disoproxil fumarate (Truvada®) 200/245 mg once daily, both taken orally for 28 days.

    Number of subjects in period 1
    		Elvitegravir/cobicistat Lopinavir/ritonavir
    Started
    119
    38
    Completed
    79
    20
    Not completed
    40
    18
         Switched ART
    -
    2
         Adverse event, non-fatal
    1
    1
         HIV positive at day 1
    1
    -
         Lost to follow-up
    38
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elvitegravir/cobicistat
    Reporting group description
    		 Participants received a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®) once daily for 28 days as post-exposure prophylaxis (PEP) for HIV-1.

    Reporting group title
    Lopinavir/ritonavir
    Reporting group description
    		 Participants received lopinavir/ritonavir (Kaletra®) twice daily plus emtricitabine/tenofovir disoproxil fumarate (Truvada®) once daily for 28 days.

    Reporting group values
    		 Elvitegravir/cobicistat Lopinavir/ritonavir Total
    Number of subjects
    		 119 38 157
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 33 (27 to 40) 31 (26 to 38) -
    Gender categorical
    Units: Subjects
        Female
    		 6 2 8
        Male
    		 113 36 149

    End points

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    End points reporting groups
    Reporting group title
    Elvitegravir/cobicistat
    Reporting group description
    		 Participants received a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®) once daily for 28 days as post-exposure prophylaxis (PEP) for HIV-1.

    Reporting group title
    Lopinavir/ritonavir
    Reporting group description
    		 Participants received lopinavir/ritonavir (Kaletra®) twice daily plus emtricitabine/tenofovir disoproxil fumarate (Truvada®) once daily for 28 days.

    Primary: PEP non-completion and lost to follow-up

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    End point title
    		 PEP non-completion and lost to follow-up [1]
    End point description
    Proportion of patients who discontinue the initial post-exposure prophylaxis (PEP) regimen for any reason before completing 28 days of treatment. A patient is considered to have discontinued if they die, do not attend the week 4 visit, or switch/stop the study treatment.
    End point type
    Primary
    End point timeframe
    Day 28
    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: Although no formal statistical model was applied in the EudraCT entry, the primary endpoint (PEP non-completion before day 28) was descriptively compared between arms using proportions. The study was exploratory in nature and not powered for formal hypothesis testing. The results are presented as counts and percentages per arm.
    End point values
    		 Elvitegravir/cobicistat Lopinavir/ritonavir
    Number of subjects analysed
    119
    38
    Units: Subjects
        Completed
    79
    20
        Not completed
    40
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of informed consent until the last follow-up visit (week 24).
    Adverse event reporting additional description
    Adverse events were collected at each scheduled visit through clinical observation, laboratory tests, and open-ended patient interviews. Serious adverse events were reported within 24 hours to the study monitor and followed until resolution or stabilization.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Elvitegravir/cobicistat
    Reporting group description
    		 -

    Reporting group title
    Lopinavir/ritonavir
    Reporting group description
    		 -

    Serious adverse events
    		 Elvitegravir/cobicistat Lopinavir/ritonavir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Elvitegravir/cobicistat Lopinavir/ritonavir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 119 (48.74%)
    34 / 38 (89.47%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 119 (5.04%)
    10 / 38 (26.32%)
         occurrences all number
    6
    12
    General disorders and administration site conditions
    Other
    Additional description: Other non-serious adverse events not individually specified in the publication.
         subjects affected / exposed
    34 / 119 (28.57%)
    0 / 38 (0.00%)
         occurrences all number
    34
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 119 (8.40%)
    25 / 38 (65.79%)
         occurrences all number
    10
    30
    Nausea
         subjects affected / exposed
    8 / 119 (6.72%)
    25 / 38 (65.79%)
         occurrences all number
    8
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Limitations: 21% of patients were lost to follow-up at day 1, most participants were MSM (92%) with only 5% women, and limited data were available on partners’ HIV status and STIs. HIV testing at ER was not performed due to hospital protocols.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/290912
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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