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    Clinical Trial Results:
    A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL

    Summary
    EudraCT number
    		 2019-000588-26
    Trial protocol
    		 FR   PT   GB   DE   IT  
    Global end of trial date
    01 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2024
    First version publication date
    13 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    8591A-019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04233216
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, Rahway, NJ, United States, P.O. Box 2000
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.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
    01 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 2020
    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
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    South Africa: 6
    Country: Number of subjects enrolled
    Peru: 1
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Ukraine: 1
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    35
    EEA total number of subjects
    8
    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)
    34
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Heavily Treatment-Experienced (HTE) adult participants with Human Immunodeficiency Virus Type 1 (HIV-1) infection and currently on failing antiretroviral therapy (ART) were enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ISL + ART
    Arm description
    		 HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doravirine/Islatravir
    Investigational medicinal product code
    Other name
    MK-8591A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg doravirine /0.75 mg islatravir FDC QD from day 8 to Day 97

    Investigational medicinal product name
    Islatravir
    Investigational medicinal product code
    Other name
    MK-8591
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.75 mg islatravir once daily (QD) from day 1 to 7

    Arm title
    		 DOR + ART
    Arm description
    		 HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doravirine
    Investigational medicinal product code
    Other name
    MK-1439
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg doravirine QD from day 1 to 7

    Investigational medicinal product name
    Doravirine/Islatravir
    Investigational medicinal product code
    Other name
    MK-8591A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg doravirine /0.75 mg islatravir fixed dose combination (FDC) QD from day 8 to Day 97

    Arm title
    		 DOR/ISL + ART
    Arm description
    		 HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doravirine/Islatravir
    Investigational medicinal product code
    Other name
    MK-8591A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg doravirine /0.75 mg islatravir FDC QD from day 1 to Day 97

    Arm title
    		 Placebo + ART
    Arm description
    		 HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to islatravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to islatravir

    Investigational medicinal product name
    Doravirine/Islatravir
    Investigational medicinal product code
    Other name
    MK-8591A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg doravirine /0.75 mg islatravir FDC QD from day 8 to Day 97

    Investigational medicinal product name
    Placebo to doravirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to doravirine

    Number of subjects in period 1
    		ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Started
    7
    14
    7
    7
    Completed
    6
    9
    4
    5
    Not completed
    1
    5
    3
    2
         Physician decision
    -
    3
    -
    2
         Consent withdrawn by subject
    -
    2
    1
    -
         Lost to follow-up
    1
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ISL + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.

    Reporting group title
    DOR + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    DOR/ISL + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    Placebo + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART Total
    Number of subjects
    		 7 14 7 7 35
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 7 14 6 7 34
        From 65-84 years
    		 0 0 1 0 1
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.6 ( 12.7 ) 48.6 ( 11.8 ) 54.0 ( 10.0 ) 44.6 ( 9.1 ) -
    Sex: Female, Male
    Units:
        Female
    		 2 4 1 1 8
        Male
    		 5 10 6 6 27
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 1 0 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 5 5 0 1 11
        White
    		 2 7 6 5 20
        More than one race
    		 0 1 1 0 2
        Unknown or Not Reported
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 2 2 0 4
        Not Hispanic or Latino
    		 7 12 5 7 31
        Unknown or Not Reported
    		 0 0 0 0 0
    Plasma HIV-1 RNA
    Units: Log10 copies/mL
        arithmetic mean (standard deviation)
    		 4.1 ( 0.8 ) 4.3 ( 0.9 ) 4.5 ( 0.8 ) 4.2 ( 0.7 ) -
    Custer of differentiation 4+ (CD4+) T-cell Count
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    		 166.3 ( 121.7 ) 132.4 ( 136.6 ) 178.6 ( 135.5 ) 132.6 ( 100.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    ISL + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.

    Reporting group title
    DOR + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    DOR/ISL + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    Placebo + ART
    Reporting group description
    		 HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Subject analysis set title
    Pooled Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol

    Primary: Percentage of participants receiving doravirine/islatravir (DOR/ISL) with ≥0.5 log10 change from Day 1 baseline to Day 8 in human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment

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    End point title
    		 Percentage of participants receiving doravirine/islatravir (DOR/ISL) with ≥0.5 log10 change from Day 1 baseline to Day 8 in human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment [1]
    End point description
    Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) and Day 8
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    0 [2]
    0 [3]
    7
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    ( to )
    ( to )
    85.7 (42.1 to 99.6)
    0.0 (0.0 to 41.0)
    Notes
    [2] - Only participants treated with DOR/ISL FDC or placebo were analyzed in this endpoint.
    [3] - Only participants treated with DOR/ISL FDC or placebo were analyzed in this endpoint.
    No statistical analyses for this end point

    Primary: Percentage of participants with ≥1 AEs through week 49

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    End point title
    		 Percentage of participants with ≥1 AEs through week 49 [4]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 49 weeks
    Notes
    [4] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    71.4
    85.7
    85.7
    85.7
    No statistical analyses for this end point

    Primary: Percentage of participants withdrawing from study treatment due to AE(s) through week 25

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    End point title
    		 Percentage of participants withdrawing from study treatment due to AE(s) through week 25 [5]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 25 weeks
    Notes
    [5] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    0.0
    7.1
    14.3
    0.0
    No statistical analyses for this end point

    Primary: Percentage of participants withdrawing from study treatment due to AE(s) through week 49

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    End point title
    		 Percentage of participants withdrawing from study treatment due to AE(s) through week 49 [6]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 49 weeks
    Notes
    [6] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    0.0
    14.3
    14.3
    0.0
    No statistical analyses for this end point

    Primary: Percentage of participants with ≥1 adverse events (AEs) through week 25

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    End point title
    		 Percentage of participants with ≥1 adverse events (AEs) through week 25 [7]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 25 weeks
    Notes
    [7] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    42.9
    85.7
    85.7
    85.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥1 adverse events (AEs) through week 97

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    End point title
    		 Percentage of participants with ≥1 adverse events (AEs) through week 97
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Up to 97 weeks
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    85.7
    100.0
    85.7
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of participants discontinuing from study therapy due to AE(s) through week 97

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    End point title
    		 Percentage of participants discontinuing from study therapy due to AE(s) through week 97
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Up to 97 weeks
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (not applicable)
    0.0
    21.4
    28.6
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of participants receiving DOR or ISL (given with antiretroviral therapy [ART]) with ≥0.5 log10 change from Day 1 baseline to Day 8 HIV-1 RNA compared to placebo treatment

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    End point title
    		 Percentage of participants receiving DOR or ISL (given with antiretroviral therapy [ART]) with ≥0.5 log10 change from Day 1 baseline to Day 8 HIV-1 RNA compared to placebo treatment
    End point description
    Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    0 [8]
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    28.6 (3.7 to 71.0)
    78.6 (49.2 to 95.3)
    ( to )
    0.0 (0.0 to 41.0)
    Notes
    [8] - Participants treated with DOR/ISL FDC were not analyzed in this endpoint.
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 1 to Day 8 in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment

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    End point title
    		 Mean change from baseline Day 1 to Day 8 in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment
    End point description
    The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -0.44 (-0.96 to 0.07)
    -0.96 (-1.38 to -0.54)
    -1.23 (-1.72 to -0.75)
    0.03 (-0.15 to 0.21)
    No statistical analyses for this end point

    Secondary: Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 change from Day 1 baseline to Day 8 HIV-1 RNA compared to placebo treatment

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    End point title
    		 Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 change from Day 1 baseline to Day 8 HIV-1 RNA compared to placebo treatment
    End point description
    Participants with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    14.3 (0.4 to 57.9)
    50.0 (23.0 to 77.0)
    85.7 (42.1 to 99.6)
    0.0 (0.0 to 41.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants receiving DOR/ISL (given with ART) with ≥0.5 log10 change from Day 1 baseline to Day 8 in HIV-1 RNA compared to DOR or ISL treatment

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    End point title
    		 Percentage of participants receiving DOR/ISL (given with ART) with ≥0.5 log10 change from Day 1 baseline to Day 8 in HIV-1 RNA compared to DOR or ISL treatment
    End point description
    Participants with a ≥0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    0 [9]
    Units: Percentage of participants
        number (confidence interval 95%)
    28.6 (3.7 to 71.0)
    78.6 (49.2 to 95.3)
    85.7 (42.1 to 99.6)
    ( to )
    Notes
    [9] - The group treated with placebo were not analyzed in this endpoint.
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 1 to Day 8 in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment

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    End point title
    		 Mean change from baseline Day 1 to Day 8 in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment
    End point description
    The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the t-distribution. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    0 [10]
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -0.44 (-0.96 to 0.07)
    -0.96 (-1.38 to -0.54)
    -1.23 (-1.72 to -0.75)
    ( to )
    Notes
    [10] - The group treated with placebo were not analyzed in this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 25 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 25 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    85.3 (68.9 to 95.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants receiving DOR/ISL (given with ART) with ≥1.0 log10 change from Day 1 baseline to Day 8 in HIV-1 RNA compared to DOR or ISL treatment

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    End point title
    		 Percentage of participants receiving DOR/ISL (given with ART) with ≥1.0 log10 change from Day 1 baseline to Day 8 in HIV-1 RNA compared to DOR or ISL treatment
    End point description
    Participants receiving DOR/ISL with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    0 [11]
    Units: Percentage of participants
        number (confidence interval 95%)
    14.3 (0.4 to 57.9)
    50.0 (23.0 to 77.0)
    85.7 (42.1 to 99.6)
    ( to )
    Notes
    [11] - Participants treated with placebo were not analyzed in this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 97 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 97 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    84.6 (65.1 to 95.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 25 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 25 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    64.7 (46.5 to 80.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 49 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 49 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    67.7 (48.6 to 83.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 49 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 1 baseline to Week 49 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    80.6 (62.5 to 92.5)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 97 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥0.5 log10 change from Day 8 baseline to Week 97 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    69.2 (48.2 to 85.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 25 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 25 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    58.8 (40.7 to 75.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 97 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 97 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    73.1 (52.2 to 88.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 49 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 49 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    71.0 (52.0 to 85.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 25 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 1 baseline to Week 25 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    67.6 (49.5 to 82.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 97 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 97 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    61.5 (40.6 to 79.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 49 in HIV-1 RNA

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    End point title
    		 Percentage of participants from the pooled treatment group with ≥1.0 log10 change from Day 8 baseline to Week 49 in HIV-1 RNA
    End point description
    The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    61.3 (42.2 to 78.2)
    No statistical analyses for this end point

    Secondary: Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <200 copies mL

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    End point title
    		 Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <200 copies mL
    End point description
    The percentage of participants with HIV-1 RNA <200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 1
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 41.0)
        Day 8
    0.0 (0.0 to 41.0)
    14.3 (1.8 to 42.8)
    14.3 (0.4 to 57.9)
    0.0 (0.0 to 41.0)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 8 to Week 97 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 8 to Week 97 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -1.36 (-1.83 to -0.89)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 8 to Week 49 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 8 to Week 49 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -1.32 (-1.72 to -0.91)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 8 to Week 25 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 8 to Week 25 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -1.16 (-1.56 to -0.77)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 1 to Week 97 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 1 to Week 97 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -2.01 (-2.51 to -1.52)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 1 to Week 25 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 1 to Week 25 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -1.89 (-2.33 to -1.45)
    No statistical analyses for this end point

    Secondary: Mean change from baseline Day 1 to Week 49 in HIV-1 RNA from the pooled treatment group

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    End point title
    		 Mean change from baseline Day 1 to Week 49 in HIV-1 RNA from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Log10 Copies/mL
        arithmetic mean (confidence interval 95%)
    -2.00 (-2.47 to -1.53)
    No statistical analyses for this end point

    Secondary: Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <50 copies mL

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    End point title
    		 Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <50 copies mL
    End point description
    The percentage of participants with HIV-1 RNA <50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 1
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 41.0)
        Day 8
    0.0 (0.0 to 41.0)
    14.3 (1.8 to 42.8)
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 41.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 97

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 97
    End point description
    The percentage of participants with HIV-1 RNA <200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    80.8 (60.6 to 93.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 49
    End point description
    The percentage of participants with HIV-1 RNA <200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    77.4 (58.9 to 90.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <200 copies/mL at Week 25
    End point description
    The percentage of participants with HIV-1 RNA <200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    64.7 (46.5 to 80.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <40 copies mL

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    End point title
    		 Percentage of participants from Day 1 baseline to Day 8 with HIV-1 RNA <40 copies mL
    End point description
    The percentage of participants with HIV-1 RNA <40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. The population analyzed was all randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Day 8
    End point values
    		 ISL + ART DOR + ART DOR/ISL + ART Placebo + ART
    Number of subjects analysed
    7
    14
    7
    7
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 1
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 41.0)
        Day 8
    0.0 (0.0 to 41.0)
    14.3 (1.8 to 42.8)
    0.0 (0.0 to 41.0)
    0.0 (0.0 to 41.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 97

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 97
    End point description
    The percentage of participants with HIV-1 RNA <40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    69.2 (48.2 to 85.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 49
    End point description
    The percentage of participants with HIV-1 RNA <40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    71.0 (52.0 to 85.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 49
    End point description
    The percentage of participants with HIV-1 RNA <50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    31
    Units: Percentage of participants
        number (confidence interval 95%)
    71.0 (52.0 to 85.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 97

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 97
    End point description
    The percentage of participants with HIV-1 RNA <50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    26
    Units: Percentage of participants
        number (confidence interval 95%)
    69.2 (48.2 to 85.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <40 copies/mL at Week 25
    End point description
    The percentage of participants with HIV-1 RNA <40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    58.8 (40.7 to 75.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with HIV-1 RNA <50 copies/mL at Week 25
    End point description
    The percentage of participants with HIV-1 RNA <50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    58.8 (40.7 to 75.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to OBT components at week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to OBT components at week 49
    End point description
    The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    7
    Units: Percentage of participants
        number (not applicable)
    28.6
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group with viral resistance-associated substitutions (RASs) at Week 25

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    End point title
    		 Number of participants from the pooled treatment group with viral resistance-associated substitutions (RASs) at Week 25
    End point description
    The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    12
    Units: Participants
        RAS A98G
    2
        RAS D67N
    1
        RAS H221Y
    1
        RAS K103S
    1
        RAS K219E
    1
        RAS L234I
    1
        RAS M184V
    1
        RAS M41L
    1
        RAS N348I
    1
        RAS V106A
    3
        RAS V106I
    2
        RAS V106M
    1
        RAS V179I
    2
        RAS Y318F
    1
        RAS F53L
    1
        RAS L90M
    1
        RAS M36I
    1
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to DOR at week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to DOR at week 49
    End point description
    The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    7
    Units: Percentage of participants
        number (not applicable)
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to ISL at week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to ISL at week 25
    End point description
    The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    12
    Units: Percentage of participants
        number (not applicable)
    8.3
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to ISL at week 49

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to ISL at week 49
    End point description
    The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    7
    Units: Percentage of participants
        number (not applicable)
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to optimized background therapy (OBT) components at week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to optimized background therapy (OBT) components at week 25
    End point description
    The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    12
    Units: Percentage of participants
        number (not applicable)
    25.0
    No statistical analyses for this end point

    Secondary: Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to DOR at week 25

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    End point title
    		 Percentage of participants from the pooled treatment group with treatment-emergent resistance-associated substitutions to DOR at week 25
    End point description
    The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    12
    Units: Percentage of participants
        number (not applicable)
    33.3
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group with viral RASs at Week 49

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    End point title
    		 Number of participants from the pooled treatment group with viral RASs at Week 49
    End point description
    The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    7
    Units: Participants
        RAS A98G
    1
        RAS D67N
    1
        RAS K103S
    1
        RAS K219E
    1
        RAS M184V
    1
        RAS M41L
    1
        RAS N348I
    1
        RAS V106A
    2
        RAS V106I
    1
        RAS V106M
    1
        RAS V179I
    2
        RAS F53L
    1
        RAS L90M
    1
        RAS M36I
    1
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group with viral RASs at Week 97

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    End point title
    		 Number of participants from the pooled treatment group with viral RASs at Week 97
    End point description
    The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    5
    Units: Participants
        RAS D67N
    1
        RAS M41L
    1
        RAS N348I
    1
        RAS T215F
    1
        RAS V106A
    2
        RAS V106I
    1
        RAS V106M
    1
        RAS V179I
    1
        RAS F53L
    1
        RAS L90M
    1
        RAS M36I
    1
    No statistical analyses for this end point

    Secondary: Change from baseline Day 1 to Week 25 in cluster of differentiation 4+ (CD4+) T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 1 to Week 25 in cluster of differentiation 4+ (CD4+) T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    30
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    50.3 (27.8 to 72.9)
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25

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    End point title
    		 Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25
    End point description
    The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25 is presented. .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    35
    Units: Participants
    12
    No statistical analyses for this end point

    Secondary: Change from baseline Day 1 to Week 97 in CD4+ T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 1 to Week 97 in CD4+ T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    24
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    114.6 (54.7 to 174.6)
    No statistical analyses for this end point

    Secondary: Change from baseline Day 1 to Week 49 in CD4+ T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 1 to Week 49 in CD4+ T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    30
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    86.9 (51.2 to 122.5)
    No statistical analyses for this end point

    Secondary: Change from baseline Day 8 to Week 25 in CD4+ T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 8 to Week 25 in CD4+ T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 25
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    30
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    38.0 (9.6 to 66.4)
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97

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    End point title
    		 Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97
    End point description
    The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97 is presented. .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    35
    Units: Participants
    5
    No statistical analyses for this end point

    Secondary: Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49

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    End point title
    		 Number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49
    End point description
    The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49 is presented. .Analysis of the pooled treatment group was planned per protocol. The population analyzed was all randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
    End point type
    Secondary
    End point timeframe
    Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    35
    Units: Participants
    7
    No statistical analyses for this end point

    Secondary: Change from baseline Day 8 to Week 97 in CD4+ T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 8 to Week 97 in CD4+ T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 97
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    24
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    108.0 (47.9 to 168.2)
    No statistical analyses for this end point

    Secondary: Change from baseline Day 8 to Week 49 in CD4+ T-cell counts from the pooled treatment group

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    End point title
    		 Change from baseline Day 8 to Week 49 in CD4+ T-cell counts from the pooled treatment group
    End point description
    The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol. The population analyzed was randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
    End point type
    Secondary
    End point timeframe
    Day 8 (baseline) and Week 49
    End point values
    		 Pooled Treatment
    Number of subjects analysed
    30
    Units: cells/mm^3
        arithmetic mean (confidence interval 95%)
    75.1 (36.9 to 113.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    ISL+ART
    Reporting group description
    		 HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.

    Reporting group title
    Placebo+ART
    Reporting group description
    		 HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    DOR/ISL+ART
    Reporting group description
    		 HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

    Reporting group title
    DOR+ART
    Reporting group description
    		 HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97

    Serious adverse events
    		 ISL+ART Placebo+ART DOR/ISL+ART DOR+ART
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Castleman's disease
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reactive gastropathy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SARS-CoV-2 sepsis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ISL+ART Placebo+ART DOR/ISL+ART DOR+ART
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    7 / 7 (100.00%)
    6 / 7 (85.71%)
    14 / 14 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anogenital warts
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Kaposi's sarcoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Penile squamous cell carcinoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Nocturnal hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Intermittent claudication
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    2
    2
    1
    1
    Feeling hot
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    1
    1
    Injection site nodule
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    1
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sleep terror
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Blood calcium increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    2
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    CD4 lymphocytes decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    2
    1
    0
    3
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intestinal transit time increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    5 / 14 (35.71%)
         occurrences all number
    0
    0
    0
    6
    Weight increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Accidental overdose
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Exposure to communicable disease
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Humerus fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tendon rupture
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Mitral valve incompetence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Myelopathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Motor dysfunction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    0
    3
    Head discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    1
    Pancytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Cataract
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Retinal haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Anal rash
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    2
    2
    Haemorrhoids
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Diverticulum
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    4 / 14 (28.57%)
         occurrences all number
    0
    1
    3
    5
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    1
    Acanthosis nigricans
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Acute kidney injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    1
    0
    2
    Axillary mass
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint effusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Muscle tightness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Osteonecrosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Polyarthritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    4 / 14 (28.57%)
         occurrences all number
    1
    2
    0
    4
    Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Amoebiasis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Epididymitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    0
    2
    Skin candida
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    4
    2
    0
    3
    Fungal foot infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Decreased appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Obesity
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2020
    Amendment 01: Assessment of fasting lipid and glucose profiles were added to the protocol.
    24 Jun 2020
    Amendment 02: Allow participants to rescreen following consultation with the Sponsor. The lower age limit of 12 years was removed.
    08 Jan 2021
    Amendment 03: Extend Part 2 of the study from 48 weeks to 96 weeks of open-label intervention with DOR/ISL + OBT, permit continued administration of study intervention in participants who become pregnant, add a discontinuation criterion if a participant chooses to breastfeed, and add a Per-Protocol analysis to the SAP.
    12 Jul 2021
    Amendment 06: Modified inclusion criteria to clearly characterize the HTE study population as individuals with no more than 2 fully active antiretroviral drugs across all approved antiretroviral classes.
    23 Feb 2022
    Amendment 08: Given the findings of decreases in CD4+ T-cell and total lymphocyte counts in clinical studies evaluating ISL, the protocol is being amended to increase the frequency of monitoring of CD4+ T-cell and total lymphocyte counts and to specify the management of participants who meet protocol-defined decreases in CD4+ T-cell and/or total lymphocyte counts.
    26 Sep 2022
    Amendment 09: Merck Sharp & Dohme Corp. underwent an entity name and address change to Merck Sharp & Dohme LLC, Rahway, NJ, USA. This conversion resulted only in an entity name change and update to the address.

    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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