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    Clinical Trial Results:
    A prospective, multicenter, randomized, open-label trial to assess the safety, tolerability and efficacy of dual therapy with boosted Darunavir + Dolutegravir when switching from standard of care ART in HIV-patients with sustained virological Suppression (DUALIS-Study)

    Summary
    EudraCT number
    		 2015-000360-34
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2020
    First version publication date
    29 Jul 2020
    Other versions
    Summary report(s)
    		 CSR_DUALIS

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DUA-1463-SPI-0320-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02486133
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, Munich, Germany, 81675
    Public contact
    PD Dr. Christoph Spinner, Klinikum rechts der Isar der TU München, Klinik für Innere Medizin II , Technische Universität München, Fakultät für Medizin, 49 89 4140 2251, christoph.spinner@tum.de
    Scientific contact
    PD Dr. Christoph Spinner, Klinikum rechts der Isar der TU München, Klinik für Innere Medizin II , Technische Universität München, Fakultät für Medizin, 49 89 4140 2251, christoph.spinner@tum.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The clinical trial investigates whether a switch strategy of dual therapy with DRV/r + DTG is non-inferior with respect to HIV RNA < 50 cps/ml (ITTe analysis, FDA snapshot analysis (missing, switch or discontinuation of investigational study drugs for any reason = failure; change of NRTI backbone combination will not be classified as failure for primary endpoint analysis)) to a continuous standard of care therapy with DRV/r in combination with 2 NRTIs (ABC/3TC, F/TDF or F/TAF) over 48 weeks in HIV patients, who are on at least 24 weeks prior to randomisation of a stable and fully suppressive ART, consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days prior to randomisation (HIV RNA < 50 cps/ml and within a period of 24 weeks prior to randomisation with one accepted blip of HIV- RNA < 200 cps/ml).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 Standard of care.
    Evidence for comparator
    		 Modern combination antiretroviral therapy (cART) leads to well-controlled HIV infection with a potentially normal life expectancy [1]. Nucleosidic reverse transcriptase inhibitors (NRTIs) play a major role as “ART backbone” and are essential antiretroviral agents according to current European and WHO HIV treatment guidelines. Alternative NRTI free (so called "nuke sparing") therapy options have been evaluated in different studies but were associated with less virologic therapeutic success and higher rates of therapy induced resistance compared to standard regimens in ART naïve patients. This is particularly true for patients with a high baseline viral load. As an alternative to NRTI-based therapy options, Ritonavir-boosted protease inhibitor (PI/r)-based nuke-sparing dual therapies have been studied widely, mostly in combination with the integrase inhibitor (INI) Raltegravir (RAL). The HIV protease inhibitor Darunavir (DRV) and the novel INI Dolutegravir (DTG) are both very potent anchor drugs with a high barrier to resistance. Due to a favourable side-effect profile, a once-daily (QD) formulation and its virological potency, DRV is currently one of the most frequently used PIs in Europe and the USA. In addition, the new, once-daily administrable integrase inhibitor DTG showed an excecellent tolerability profile as well as a high resistance barrier. The nuke-free combination of DTG (50 mg) with the Ritonavir (/r)- or Cobicistat-boosted protease inhibitor DRV (800 mg) may offer a favorable safety and efficacy profile with the advantage of QD-dosing.
    Actual start date of recruitment
    31 Jul 2015
    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: 269
    Worldwide total number of subjects
    269
    EEA total number of subjects
    269
    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)
    261
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Pre-screening processes were in place. Between 31.07.2015 and 01.06.2018 all patients were randomised.

    Pre-assignment
    Screening details
    		 Requirements for inclusion: HIV- infection within a period of at least 24 weeks suppressive ART prior to randomization, with one accepted blip of HIV- RNA < 200 cps/ml and well-tolerated antiretroviral therapy: consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days Prior to randomization.

    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
    		 Control Arm: DRV QD + 2 NRTIs
    Arm description
    		 Control arm: DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Tenofovir disoproxil / emtricitabine 245/200 mg (Truvada®), oral, once daily or DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Abacavir / Lamivudine 600/300 mg (Kivexa®), oral, once daily or in combination with Tenofovir alafenamid / emtricitabine 10/200 mg (Descovy®); oral; once daily; Duration: 48 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    J05AE10
    Other name
    Prezista, SUB25394, 206361-99-1, DARUNAVIR monoethanolat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg per day

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    J05AE03
    Other name
    155213-67-5, SUB10342MIG
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg milligram(s) per day

    Investigational medicinal product name
    Tenofovir disoproxil / emtricitabine
    Investigational medicinal product code
    J05AR03
    Other name
    Truvada
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Other use
    Dosage and administration details
    200/250 mg milligram(s) per day

    Investigational medicinal product name
    Abacavir / Lamivudine
    Investigational medicinal product code
    J05AR02
    Other name
    Kivexa, EU/1/04/298/001
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/300 mg milligram(s) per day

    Investigational medicinal product name
    Tenofovir alafenamid / emtricitabine
    Investigational medicinal product code
    J05AR17
    Other name
    Descovy
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Other use
    Dosage and administration details
    10/200 mg milligram(s) per day

    Arm title
    		 Interventional arm: DRV QD + DTG
    Arm description
    		 DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily and DTG 50 mg tablets (Tivicay®), oral, once daily. Duration of intervention per patient 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    J05AE10
    Other name
    Prezista, SUB25394, 206361-99-1, DARUNAVIR monoethanolat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg per day

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    J05AE03
    Other name
    155213-67-5, SUB10342MIG
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg milligram(s) per day

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    J05AX12
    Other name
    Tivicay, EU/1/13/892/001
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg milligram(s) per day

    Number of subjects in period 1
    		Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Started
    135
    134
    Completed
    122
    119
    Not completed
    13
    15
         Consent withdrawn by subject
    4
    4
         Adverse event, non-fatal
    1
    6
         No exposure to study drug
    3
    3
         Lost to follow-up
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 269 269
    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
    Age at start of study
    Units: years
        median (full range (min-max))
    		 48 (21 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 242 242
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT analysis set consists of all trial subjects enrolled into the trial and randomized with at least a baseline visit and at least one dose of study drug.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population consists of all trial subjects who were treated according to protocol. Patients with major protocol violations have been excluded from the PP analysis due to decision at data review meeting.

    Subject analysis set title
    SA
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of all trial subjects who received at least one dose of IMP.

    Subject analysis sets values
    		 ITT PP SA
    Number of subjects
    263
    241
    266
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Age at start of study
    Units: years
        median (full range (min-max))
    48 (21 to 71)
    48 (21 to 73)
    Gender categorical
    Units: Subjects
        Female
    26
    23
    27
        Male
    237
    218
    239

    End points

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    End points reporting groups
    Reporting group title
    Control Arm: DRV QD + 2 NRTIs
    Reporting group description
    		 Control arm: DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Tenofovir disoproxil / emtricitabine 245/200 mg (Truvada®), oral, once daily or DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Abacavir / Lamivudine 600/300 mg (Kivexa®), oral, once daily or in combination with Tenofovir alafenamid / emtricitabine 10/200 mg (Descovy®); oral; once daily; Duration: 48 weeks

    Reporting group title
    Interventional arm: DRV QD + DTG
    Reporting group description
    		 DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily and DTG 50 mg tablets (Tivicay®), oral, once daily. Duration of intervention per patient 48 weeks.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT analysis set consists of all trial subjects enrolled into the trial and randomized with at least a baseline visit and at least one dose of study drug.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population consists of all trial subjects who were treated according to protocol. Patients with major protocol violations have been excluded from the PP analysis due to decision at data review meeting.

    Subject analysis set title
    SA
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of all trial subjects who received at least one dose of IMP.

    Primary: Number of patients with HIV RNA < 50 cps/ml at week 48 (ITT)

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    End point title
    		 Number of patients with HIV RNA < 50 cps/ml at week 48 (ITT)
    End point description
    End point type
    Primary
    End point timeframe
    HIV RNA counts collected at visit Week 48.
    End point values
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG ITT
    Number of subjects analysed
    132 [1]
    131 [2]
    263
    Units: Patients
        HIV RNA < 50 cps/ml
    116
    113
    229
        HIV RNA >= 50 cps/ml
    16
    18
    34
    Notes
    [1] - The primary endpoint is analyzed on the ITT set.
    [2] - The primary endpoint is analyzed on the ITT set.
    Statistical analysis title
    		 Response rate CI
    Statistical analysis description
    Mean difference (proportion(2DR) - proportion(3DR)) with 95.48%CI (based on the adjusted alpha-level accounting for the interim analysis at week 24).
    Comparison groups
    Control Arm: DRV QD + 2 NRTIs v Interventional arm: DRV QD + DTG v ITT
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0162
    Confidence interval
         level
    		 95.48%
         sides
    2-sided
         lower limit
    		 -0.0991
         upper limit
    		 0.0667
    Notes
    [3] - The non-inferiority margin is 10%.

    Secondary: Number of patients with HIV RNA < 50 cps/ml at week 48 (PP)

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    End point title
    		 Number of patients with HIV RNA < 50 cps/ml at week 48 (PP)
    End point description
    End point type
    Secondary
    End point timeframe
    HIV RNA counts collected at visit Week 48.
    End point values
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Number of subjects analysed
    119 [4]
    122 [5]
    Units: Patients
        HIV RNA <50 cps/ml
    113
    116
        HIV RNA >= 50 cps/ml
    6
    6
    Notes
    [4] - This endpoint was evaluated on the PP set.
    [5] - This endpoint was evaluated on the PP set.
    Statistical analysis title
    		 Response rate CI on PP
    Statistical analysis description
    Confidence interval for the difference in response rate in the PP analysis set
    Comparison groups
    Control Arm: DRV QD + 2 NRTIs v Interventional arm: DRV QD + DTG
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0068
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.046
         upper limit
    		 0.0597

    Secondary: Number of patients with HIV RNA < 50 cps/ml at week 24 (ITT)

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    End point title
    		 Number of patients with HIV RNA < 50 cps/ml at week 24 (ITT)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Number of subjects analysed
    135
    134
    Units: Patients
        HIV RNA < 50 cps/ml
    117
    116
        HIV RNA >= 50 cps/ml
    18
    18
    Statistical analysis title
    		 Difference in response
    Comparison groups
    Control Arm: DRV QD + 2 NRTIs v Interventional arm: DRV QD + DTG
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0537
         upper limit
    		 0.0976

    Secondary: Number of patients with HIV RNA < 50 cps/ml at week 24 (PP)

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    End point title
    		 Number of patients with HIV RNA < 50 cps/ml at week 24 (PP)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Number of subjects analysed
    119 [6]
    122 [7]
    Units: Patients
        HIV RNA < 50 cps/ml
    115
    112
        HIV RNA >= 50 cps/ml
    4
    10
    Notes
    [6] - This endpoint was evaluated on the PP set.
    [7] - This endpoint was evaluated on the PP set.
    Statistical analysis title
    		 Difference in response
    Comparison groups
    Control Arm: DRV QD + 2 NRTIs v Interventional arm: DRV QD + DTG
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0331
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0221
         upper limit
    		 0.0882

    Secondary: Immunological response at week 24 (ITT)

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    End point title
    		 Immunological response at week 24 (ITT)
    End point description
    Change in absolute CD4 cell count from baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Number of subjects analysed
    135
    134
    Units: CD4 cells
        arithmetic mean (standard deviation)
    25.2 ± 172.8
    -9.8 ± 137.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In this trial, the period of observation starts after first intake of IMP and ends 4 weeks after last vist.
    Adverse event reporting additional description
    Pre-existing diseases (before administration of the IMP) are not documented as adverse events but as concomitant diseases. New diseases and pre-existing diseases that worsen during the trial are documented as AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Control Arm: DRV QD + 2 NRTIs
    Reporting group description
    		 Control arm: DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Tenofovir disoproxil / emtricitabine 245/200 mg (Truvada®), oral, once daily or DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily in combination with Abacavir / Lamivudine 600/300 mg (Kivexa®), oral, once daily or in combination with Tenofovir alafenamid / emtricitabine 10/200 mg (Descovy®); oral; once daily; Duration: 48 weeks

    Reporting group title
    Interventional arm: DRV QD + DTG
    Reporting group description
    		 DRV 800 mg tablets (Prezista®), oral, once daily and RTV 100 mg tablets (Norvir®), oral, once daily and DTG 50 mg tablets (Tivicay®), oral, once daily. Duration of intervention per patient 48 weeks.

    Serious adverse events
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 133 (5.26%)
    7 / 133 (5.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Papilloma excision
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (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
    Headache
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paresthesia
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenectomy
         subjects affected / exposed
    0 / 133 (0.00%)
    2 / 133 (1.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    in-stent arterial stenosis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anorectal disorder
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhoids
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic infection
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Arm: DRV QD + 2 NRTIs Interventional arm: DRV QD + DTG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 133 (60.15%)
    82 / 133 (61.65%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 133 (5.26%)
    4 / 133 (3.01%)
         occurrences all number
    8
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 133 (5.26%)
    0 / 133 (0.00%)
         occurrences all number
    8
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 133 (7.52%)
    12 / 133 (9.02%)
         occurrences all number
    14
    13
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 133 (0.00%)
    6 / 133 (4.51%)
         occurrences all number
    0
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 133 (3.76%)
    8 / 133 (6.02%)
         occurrences all number
    5
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 133 (3.01%)
    10 / 133 (7.52%)
         occurrences all number
    4
    11
    Nasopharyngitis
         subjects affected / exposed
    34 / 133 (25.56%)
    36 / 133 (27.07%)
         occurrences all number
    46
    50
    Gastroenteritis
         subjects affected / exposed
    7 / 133 (5.26%)
    3 / 133 (2.26%)
         occurrences all number
    8
    4
    Syphilis
         subjects affected / exposed
    6 / 133 (4.51%)
    3 / 133 (2.26%)
         occurrences all number
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2016
    Reduction of number of visits, reduction of laboratory parameters, change of inclusion and exclusion criteria: additional IMP Descovy (Emtricitabine/Tenefovir AF) accepted and reduction of required pre-ART period, extension of study period. Further study sites have been submitted and approved.

    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.
    Premature termination: 15.06.2018 due to lack of recruitment. Planned: 320 patients (160 patients in interventional (dual) arm and 160 patients in control arm) - In toal N=269 patients were enrolled in the study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28859438
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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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