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    Clinical Trial Results:
    PROSPECTIVE, RANDOMISED, CROSSOVER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE LIPID-LOWERING EFFECT OF ADDING TENOFOVIR/EMTRICITABINE CO-FORMULATION VS PLACEBO TO HIV-1-INFECTED SUBJECTS WITH DYSLIPIDEMIA AND SUSTAINED VIRAL LOAD SUPPRESSION UNDER MONOTHERAPY WITH RITONAVIR-BOOSTED PROTEASE INHIBITORS.

    Summary
    EudraCT number
    		 2011-002853-77
    Trial protocol
    		 ES  
    Global end of trial date
    25 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2016
    First version publication date
    30 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TULIP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01458977
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita Contra la SIDA
    Sponsor organisation address
    Crta. de Canyet s/n, Badalona, Spain,
    Public contact
    CRA, Fundació Lluita Contra la SIDA, +34 934978414 , jtoro@flsida.org
    Scientific contact
    CRA, Fundació Lluita Contra la SIDA, +34 934978414 , jtoro@flsida.org
    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 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the cholesterol-lowering ability of TDF/FTC co-formulation in HIV-1-infected subjects with high cholesterol levels.
    Protection of trial subjects
    No specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 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
    Spain: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible subjects included HIV-1–infected adults with hypercholesterolemia (TC level ≥200 mg/dL and/or LDL-c level ≥130 mg/dL) in the last 2 consecutive tests obtained at least 4 weeks apart before screening, receiving stable PI monotherapy with DRV/r or LPV/r and with HIV-1 RNA < 50 copies/mL during at least 6 months before screening.

    Pre-assignment
    Screening details
    		 Between November 2011 and May 2013, 48 subjects were randomized.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    As it is a double-blind clinical trial, neither the treating physician nor the patient will know whether the patient is receiving TDF/FTC or placebo. The placebo will have the same appearance as TDF/FTC co-formulation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 group A
    Arm description
    		 TDF/FTC was added for 12 weeks followed by 12 weeks of placebo (washout) and 12 additional weeks of placebo (placebo period)
    Arm type
    		 crossover placebo-controlled

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet/24 h • Composition (excipients): Denatonium benzoate, Lactose Monohydrate, Pregelatinized Starch, Croscarmellose Sodium, Magnesium Stearate, Opadry II Blue Y-30-10701. • Pharmaceutical form: Film-coated tablet. Blue, capsule-shaped tablets, debossed with “GILEAD” on one side and plain-faced on the other side.

    Investigational medicinal product name
    TDF/FTC
    Investigational medicinal product code
    Other name
    Truvada
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet/24 h Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine): It is a marketed antiretroviral drug used in general HIV management. The formulation of the active principal components corresponds to the marketed formulation.

    Arm title
    		 group B
    Arm description
    		 Addition of placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout)
    Arm type
    		 crossover placebo-controlled

    Investigational medicinal product name
    TDF/FTC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet/24h

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1tablet/24h

    Number of subjects in period 1
    		group A group B
    Started
    24
    24
    Completed
    23
    23
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    group A
    Reporting group description
    		 TDF/FTC was added for 12 weeks followed by 12 weeks of placebo (washout) and 12 additional weeks of placebo (placebo period)

    Reporting group title
    group B
    Reporting group description
    		 Addition of placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout)

    Reporting group values
    		 group A group B Total
    Number of subjects
    		 24 24 48
    Age categorical
    Age
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 24 24 48
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 44.9 (34 to 64) 42.6 (26 to 56) -
    Gender categorical
    Units: Subjects
        Male
    		 16 16 32
        Female
    		 8 8 16

    End points

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    End points reporting groups
    Reporting group title
    group A
    Reporting group description
    		 TDF/FTC was added for 12 weeks followed by 12 weeks of placebo (washout) and 12 additional weeks of placebo (placebo period)

    Reporting group title
    group B
    Reporting group description
    		 Addition of placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout)

    Primary: Total cholesterol

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    End point title
    		 Total cholesterol
    End point description
    Changes in median fasting total cholesterol levels during TDF/FTC co-formulation addition compared to placebo.
    End point type
    Primary
    End point timeframe
    Baseline and week 12
    End point values
    		 group A group B
    Number of subjects analysed
    23
    23
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Baseline
    235.9 (216.5 to 262.9)
    234.7 (213.5 to 265.9)
        Week 12
    204.9 (182.9 to 230.5)
    232 (204.9 to 255.6)
    Statistical analysis title
    		 Comparative Analysis week 12
    Statistical analysis description
    Longitudinal changes in cholesterol levels were analyzed using paired Student t test, Wilcoxon test, or Friedman t test when appropriate. The McNemar or Cochran test was used to compare proportions. All analyses were blinded and performed by intention to treat (ITT)
    Comparison groups
    group A v group B
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Differences were considered statistically significant at P < .05

    Secondary: CD4+

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    End point title
    		 CD4+
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and week 12 follow up
    End point values
    		 group A group B
    Number of subjects analysed
    23
    23
    Units: cells/microlitre
    median (inter-quartile range (Q1-Q3))
        Baseline
    610 (473.5 to 881.5)
    631.5 (513 to 937.7)
        week 12
    653.5 (484.3 to 854.7)
    640 (478 to 960)
    No statistical analyses for this end point

    Secondary: decrease trygliceride levels

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    End point title
    		 decrease trygliceride levels
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and week 12
    End point values
    		 group A group B
    Number of subjects analysed
    23
    23
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    133.7 (106.3 to 194.9)
    150.1 (124 to 192.6)
        week 12
    137.3 (104.9 to 193.1)
    141.7 (106.3 to 208.1)
    No statistical analyses for this end point

    Secondary: increase HDL-cholesterol

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    End point title
    		 increase HDL-cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and week 12
    End point values
    		 group A group B
    Number of subjects analysed
    23
    23
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    50.3 (38.7 to 58)
    48.3 (39.7 to 57)
        week 12
    44.5 (38.4 to 50.4)
    47.8 (38.7 to 58.2)
    No statistical analyses for this end point

    Secondary: evaluate adverse events

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    End point title
    		 evaluate adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and week 48
    End point values
    		 group A group B
    Number of subjects analysed
    23
    23
    Units: number
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 week follow up
    Adverse event reporting additional description
    mild diarrhea
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE grading Tab
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    LPV/r-based treatment
    Reporting group description
    		 -

    Reporting group title
    DRV/r-based treatment
    Reporting group description
    		 -

    Serious adverse events
    		 LPV/r-based treatment DRV/r-based treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 LPV/r-based treatment DRV/r-based treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
    Gastrointestinal disorders
    mild diarrhea
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jul 2012
    Addition of two more new sites: Bellvitge University Hospital and Vall d'Hebron Universitary Hospital

    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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    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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