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    Clinical Trial Results:
    A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

    Summary
    EudraCT number
    		 2011-004420-35
    Trial protocol
    		 BE   ES   GB   AT   NL   IT   IE   PT   SE  
    Global end of trial date
    06 Oct 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-104-0423
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01850212
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    06 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the profile of low bone mineral density (BMD) in ≥ 50-year-old male HIV-1 infected subjects and postmenopausal female HIV-1 infected subjects taking tenofovir disoproxil fumarate (TDF)-based regimens relative to those taking non-TDF-based regimens for HIV infection.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 30
    Country: Number of subjects enrolled
    Portugal: 19
    Country: Number of subjects enrolled
    Spain: 89
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    United Kingdom: 77
    Country: Number of subjects enrolled
    Austria: 29
    Country: Number of subjects enrolled
    Belgium: 53
    Country: Number of subjects enrolled
    Germany: 71
    Country: Number of subjects enrolled
    Ireland: 9
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    France: 33
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Switzerland: 21
    Worldwide total number of subjects
    476
    EEA total number of subjects
    455
    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)
    385
    From 65 to 84 years
    91
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at study sites in Europe. The first subject was screened on 22 April 2013. The last study visit occurred on 06 October 2014.

    Pre-assignment
    Screening details
    		 516 subjects were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Male
    Arm description
    		 Males ≥ 50 years of age on TDF or non-TDF nucleoside reverse transcriptase inhibitor (NRTI) plus ritonavir-boosted protease inhibitor (PI/r) or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Viread®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TDF cohort: TDF as prescribed by subject's physicians. Non-TDF cohort: non-TDF NRTI plus PI/r or non-PI/r-containing regimens. Note that no investigational medicinal products were administered to subjects in this study. Subjects were taking their own antiretroviral medications as prescribed by their physicians.

    Arm title
    		 Female
    Arm description
    		 Post-menopausal females on TDF or non-TDF NRTI plus PI/r or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Viread®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TDF cohort: TDF as prescribed by subject's physicians. Non-TDF cohort: non-TDF NRTI plus PI/r or non-PI/r-containing regimens. Note that no investigational medicinal products were administered to subjects in this study. Subjects were taking their own antiretroviral medications as prescribed by their physicians.

    Number of subjects in period 1 [1]
    		Male Female
    Started
    242
    198
    Completed
    242
    198
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 15 male subjects and 21 female subjects who had a major protocol violation or missing spine or hip BMD values are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Male
    Reporting group description
    		 Males ≥ 50 years of age on TDF or non-TDF nucleoside reverse transcriptase inhibitor (NRTI) plus ritonavir-boosted protease inhibitor (PI/r) or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Reporting group title
    Female
    Reporting group description
    		 Post-menopausal females on TDF or non-TDF NRTI plus PI/r or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Reporting group values
    		 Male Female Total
    Number of subjects
    		 242 198 440
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58 ( 6.4 ) 59 ( 7.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 198 198
        Male
    		 242 0 242
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 3 4 7
        Black
    		 18 60 78
        White
    		 220 133 353
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 6 18
        Not Hispanic or Latino
    		 230 192 422

    End points

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    End points reporting groups
    Reporting group title
    Male
    Reporting group description
    		 Males ≥ 50 years of age on TDF or non-TDF nucleoside reverse transcriptase inhibitor (NRTI) plus ritonavir-boosted protease inhibitor (PI/r) or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Reporting group title
    Female
    Reporting group description
    		 Post-menopausal females on TDF or non-TDF NRTI plus PI/r or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Subject analysis set title
    TDF+PI/r
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects on a TDF plus PI/r-containing regimen were included in this analysis.

    Subject analysis set title
    TDF+Non-PI/r
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects on a TDF plus non-PI/r-containing regimen were included in this analysis.

    Subject analysis set title
    Non-TDF+PI/r
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects on a non-TDF NRTI plus PI/r-containing regimen were included in this analysis.

    Subject analysis set title
    Non-TDF+Non-PI/r
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects on a non-TDF plus non-PI/r-containing regimen were included in this analysis.

    Primary: BMD Spine L1-4 T-scores in males

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    End point title
    		 BMD Spine L1-4 T-scores in males [1]
    End point description
    BMD T-score is the bone density compared with what is normally expected in a healthy adult of your sex. T-score is the number of units (standard deviations) that bone density is above or below the average.
    End point type
    Primary
    End point timeframe
    Day 1
    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: No statistical comparison was planned or performed.
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    61
    63
    56
    60
    Units: T-score
        arithmetic mean (standard deviation)
    -1.18 ( 1.775 )
    -0.39 ( 1.701 )
    -0.75 ( 1.381 )
    -0.6 ( 1.169 )
    No statistical analyses for this end point

    Primary: BMD Spine L1-4 T-scores in females

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    End point title
    		 BMD Spine L1-4 T-scores in females [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [2] - 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: No statistical comparison was planned or performed.
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    42
    58
    32
    63
    Units: T-score
        arithmetic mean (standard deviation)
    -1.71 ( 1.303 )
    -1.3 ( 1.3 )
    -1.5 ( 1.351 )
    -1.09 ( 1.331 )
    No statistical analyses for this end point

    Primary: BMD femoral neck (hip) T-scores in males

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    End point title
    		 BMD femoral neck (hip) T-scores in males [3]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [3] - 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: No statistical comparison was planned or performed.
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    60
    63
    55
    56
    Units: T-score
        arithmetic mean (standard deviation)
    -1.34 ( 0.799 )
    -1.02 ( 1.125 )
    -1.26 ( 0.912 )
    -0.9 ( 0.848 )
    No statistical analyses for this end point

    Primary: BMD femoral neck (hip) T-scores in females

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    End point title
    		 BMD femoral neck (hip) T-scores in females [4]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    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: No statistical comparison was planned or performed.
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    41
    58
    32
    63
    Units: T-score
        arithmetic mean (standard deviation)
    -1.41 ( 1.086 )
    -1.17 ( 1.01 )
    -1.18 ( 1.191 )
    -1.21 ( 0.918 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an observed T-score < -2 for spine L1-L4 in males

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    End point title
    		 Percentage of subjects with an observed T-score < -2 for spine L1-L4 in males
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    61
    63
    56
    60
    Units: percentage of subjects
        number (not applicable)
    26.2
    17.5
    19.6
    11.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an observed T-score < -2 for spine L1-L4 in females

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    End point title
    		 Percentage of subjects with an observed T-score < -2 for spine L1-L4 in females
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    42
    58
    32
    63
    Units: percentage of subjects
        number (not applicable)
    42.9
    27.6
    34.4
    23.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an observed T-score < -2 for femoral neck in males

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    End point title
    		 Percentage of subjects with an observed T-score < -2 for femoral neck in males
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    60
    63
    55
    56
    Units: percentage of subjects
        number (not applicable)
    18.3
    19
    21.8
    5.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an observed T-score < -2 for femoral neck in females

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    End point title
    		 Percentage of subjects with an observed T-score < -2 for femoral neck in females
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    41
    58
    32
    63
    Units: percentage of subjects
        number (not applicable)
    26.8
    20.7
    25
    17.5
    No statistical analyses for this end point

    Secondary: Percentage of subjects with observed -2 ≤ T-score < -1 for spine L1-L4 in males

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    End point title
    		 Percentage of subjects with observed -2 ≤ T-score < -1 for spine L1-L4 in males
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    61
    63
    56
    60
    Units: percentage of subjects
        number (not applicable)
    39.3
    23.8
    30.4
    23.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with observed -2 ≤ T-score < -1 for spine L1-L4 in females

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    End point title
    		 Percentage of subjects with observed -2 ≤ T-score < -1 for spine L1-L4 in females
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    42
    58
    32
    63
    Units: percentage of subjects
        number (not applicable)
    31
    39.7
    31.3
    25.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects with observed -2 ≤ T-score < -1 for femoral neck in males

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    End point title
    		 Percentage of subjects with observed -2 ≤ T-score < -1 for femoral neck in males
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    60
    63
    55
    56
    Units: percentage of subjects
        number (not applicable)
    60
    25.4
    41.8
    39.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with observed -2 ≤ T-score < -1 for femoral neck in females

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    End point title
    		 Percentage of subjects with observed -2 ≤ T-score < -1 for femoral neck in females
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 TDF+PI/r TDF+Non-PI/r Non-TDF+PI/r Non-TDF+Non-PI/r
    Number of subjects analysed
    41
    58
    32
    63
    Units: percentage of subjects
        number (not applicable)
    41.5
    29.3
    31.3
    39.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were recorded from the signing of informed consent until the completion of all study-related procedures (single study visit)
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Male
    Reporting group description
    		 Males ≥ 50 years of age on TDF or non-TDF nucleoside reverse transcriptase inhibitor (NRTI) plus ritonavir-boosted protease inhibitor (PI/r) or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Reporting group title
    Female
    Reporting group description
    		 Post-menopausal females on TDF or non-TDF NRTI plus PI/r or non-PI/r-containing regimens were assessed at a single visit to collect medical history, laboratory data, and BMD information.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects experienced a non-serious adverse event that occurred in at least 5% of subjects.
    Serious adverse events
    		 Male Female
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 198 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Male Female
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 198 (0.00%)

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    There were no limitations affecting the analysis or results.
    For support, Contact us.
    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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