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    Clinical Trial Results:
    Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of 3TC (150 mg BID) plus Raltegravir (400 mg BID) switching to 3TC (300 mg QD) plus Raltegravir (1200 mg QD) : Roll-over study of the RALAM clinical trial

    Summary
    EudraCT number
    		 2017-000986-60
    Trial protocol
    		 ES  
    Global end of trial date
    24 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2025
    First version publication date
    09 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RALAM-Roll-Over
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03311945
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clinic per a la Recerca Biomédica
    Sponsor organisation address
    C/ Villarroel 170, Barcelona, Spain,
    Public contact
    Judit Pich, CTU - Clinical Trials Unit, jpich@recerca.clinic.cat
    Scientific contact
    Dr. Esteban Martinez, Hospital Clínic de Barcelona, estebanm@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
    24 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy assessed with standard plasma HIV-1 RNA detection (limit of detection 50 copies/mL) at 48 weeks.
    Protection of trial subjects
    This trial has a Data Monitoring Committee (DSMB). The trial will end if the DSMB reviews the data and detects 4 episodes of treatment failure, and subsequently every 4 new episodes of treatment failure. The study will be interrupted as soon as 5 episodes (10%) of confirmed virological failure are detected. Additionally, one of the principal inclusion criteria is that patients must have signed informed consent to participate in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 May 2018
    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
    Spain: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All trial subjects were recruited at a single site in Spain: Hospital Clínic de Barcelona. The subjects were patients in the switch arm who completed the 24-week follow-up of RALAM (NCT02284035) study and remained virologically suppressed (viral load <50 copies/mL) on dual therapy with 3TC plus Raltegravir. Recruitment start period: 08-May-2018

    Pre-assignment
    Screening details
    		 Selection and baseline will be done in the same visit. Performed at Week 0. During this visit, written informed consent was obtained from each patient, and demographic data, medical history, complete physical examination, and laboratory tests (including hematology, biochemistry, and plasma viral load) were performed to confirm eligibility.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RAL+3TC
    Arm description
    		 1200 mg raltegravir + 300 mg Lamivudine
    Arm type
    		 Experimental

    Investigational medicinal product name
    ISENTRESS
    Investigational medicinal product code
    ATC: J05AX08
    Other name
    Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1200 mg once a day (QD) during 48 weeks. It will be administred orally two 600 mg film-coated tablets of Raltegravir. Each ISENTRESS film-coated tablet contains 600 mg of raltegravir (as potassium). The rest of antiretroviral medication will be obtained through the standard prescription and dispensing route in which antiretroviral drugs are dispensed on an outpatient basis by the pharmacy service of the center.

    Investigational medicinal product name
    Epivir
    Investigational medicinal product code
    ATC: J05AF05
    Other name
    Lamivudine, Lamivudina (3TC)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 300 mg once a day (QD) during 48 weeks. It will be administred orally one 300 mg film-coated tablet of Lamivudine.

    Number of subjects in period 1
    		RAL+3TC
    Started
    33
    Completed
    33
    Period 2
    Period 2 title
    24 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RAL+3TC
    Arm description
    		 1200 mg raltegravir + 300 mg Lamivudine
    Arm type
    		 Experimental

    Investigational medicinal product name
    ISENTRESS
    Investigational medicinal product code
    ATC: J05AX08
    Other name
    Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1200 mg once a day (QD) during 48 weeks. It will be administred orally two 600 mg film-coated tablets of Raltegravir. Each ISENTRESS film-coated tablet contains 600 mg of raltegravir (as potassium).

    Investigational medicinal product name
    Epivir
    Investigational medicinal product code
    ATC: J05AF05
    Other name
    Lamivudine, Lamivudina (3TC)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 300 mg once a day (QD) during 48 weeks. It will be administred orally one 300 mg film-coated tablet of Lamivudine. The rest of antiretroviral medication will be obtained through the standard prescription and dispensing route in which antiretroviral drugs are dispensed on an outpatient basis by the pharmacy service of the center.

    Number of subjects in period 2
    		RAL+3TC
    Started
    33
    Completed
    31
    Not completed
    2
         Adverse event, non-fatal
    2
    Period 3
    Period 3 title
    48 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RAL+3TC
    Arm description
    		 1200 mg raltegravir + 300 mg Lamivudine
    Arm type
    		 Experimental

    Investigational medicinal product name
    ISENTRESS
    Investigational medicinal product code
    ATC: J05AX08
    Other name
    Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1200 mg once a day (QD) during 48 weeks. It will be administred orally two 600 mg film-coated tablets of Raltegravir. Each ISENTRESS film-coated tablet contains 600 mg of raltegravir (as potassium).

    Investigational medicinal product name
    Epivir
    Investigational medicinal product code
    ATC: J05AF05
    Other name
    Lamivudine, Lamivudina (3TC)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 300 mg once a day (QD) during 48 weeks. It will be administred orally one 300 mg film-coated tablet of Lamivudine. The rest of antiretroviral medication will be obtained through the standard prescription and dispensing route in which antiretroviral drugs are dispensed on an outpatient basis by the pharmacy service of the center.

    Number of subjects in period 3
    		RAL+3TC
    Started
    31
    Completed
    30
    Not completed
    1
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RAL+3TC
    Reporting group description
    		 1200 mg raltegravir + 300 mg Lamivudine

    Reporting group values
    		 RAL+3TC Total
    Number of subjects
    		 33 33
    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
        arithmetic mean (standard deviation)
    		 53.7 ( 12.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    RAL+3TC
    Reporting group description
    		 1200 mg raltegravir + 300 mg Lamivudine
    Reporting group title
    RAL+3TC
    Reporting group description
    		 1200 mg raltegravir + 300 mg Lamivudine
    Reporting group title
    RAL+3TC
    Reporting group description
    		 1200 mg raltegravir + 300 mg Lamivudine

    Primary: Therapeutic failure

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    End point title
    		 Therapeutic failure [1]
    End point description
    Therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death. It will be analysed also at Week 24.
    End point type
    Primary
    End point timeframe
    48 weeks.
    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: This is a single arm study.
    End point values
    		 RAL+3TC
    Number of subjects analysed
    33
    Units: Subjects
        Yes
    3
        No
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs occurring from the signing of informed consent until 30 days after receiving the last dose of the study drug were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    RAL/3TC
    Reporting group description
    		 Raltegravir 1200 mg per day plus lamivudine 300 mg per day.

    Serious adverse events
    		 RAL/3TC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RAL/3TC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 33 (9.09%)
    Blood and lymphatic system disorders
    Dizzines, asthenia, headache
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    3
    Gastrointestinal disorders
    Gastrointestinal toxicity, abdominal pain, diarrhea
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    3

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38039097
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