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    Clinical Trial Results:
    Simplification from Tenofovir plus Lamivudine or Emtricitabine plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir plus Lamivudine in Virologically-Suppressed-HIV-Infected Adults with Osteopenia: a pilot study

    Summary
    EudraCT number
    		 2014-002720-27
    Trial protocol
    		 ES  
    Global end of trial date
    30 Nov 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    2014-002720-27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02652793
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clinic per a la Recerca Biomèdica
    Sponsor organisation address
    Villarroel 170, Barcelona, Spain, 08036
    Public contact
    Judit Pich, CTU Clinic (Clinical Trial Unit), 34 932275400,
    Scientific contact
    Judit Pich, CTU Clinic (Clinical Trial Unit), 34 932275400,
    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
    30 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the change in BMD by dual-energy X-ray (DXA) absorptiometry in HIV-infected adults with hip or spine T-score < -1.0 by DXA at week 48 after switching to r/ATV plus lamivudine.
    Protection of trial subjects
    All participants provided written informed consent prior to any study-related procedures. The study was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Safety assessments—including physical examinations, laboratory tests, and monitoring of adverse events—were performed regularly throughout the study. Blood and urine samples were collected following local laboratory standards to minimize discomfort. For women of childbearing potential, pregnancy tests were conducted to ensure safety. Any adverse events were closely monitored and managed according to clinical judgment, with procedures in place for prompt reporting and follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 60 individuals were screened between Nov 2015 and Nov 2017 at Hospital Clínic, Barcelona. 29 were excluded due to normal BMD, prior virological failure, hypogonadism, or contraindicated medications. 31 participants were enrolled and assigned to treatment.

    Period 1
    Period 1 title
    Informed Consent Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RTV-boosted ATV + 3TC
    Arm description
    		 Participants received ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.
    Arm type
    		 Single group

    Investigational medicinal product name
    Boosted atazanavir
    Investigational medicinal product code
    Other name
    Atazanavir 300 mg + Ritonavir 100 mg
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    3TC
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily

    Number of subjects in period 1
    		RTV-boosted ATV + 3TC
    Started
    31
    Completed
    30
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 2
    Period 2 title
    Baseline Analysis Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RTV-boosted ATV + 3TC
    Arm description
    		 Participants received ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.
    Arm type
    		 Single group

    Investigational medicinal product name
    Boosted atazanavir
    Investigational medicinal product code
    Other name
    Atazanavir 300 mg + Ritonavir 100 mg
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    3TC
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The first period ("Informed Consent Period") includes all 31 participants who signed informed consent. However, one participant did not initiate treatment and was excluded from all baseline and outcome analyses. Therefore, the "Baseline Analysis Period" includes only the 30 participants who started treatment and for whom baseline data were collected.
    Number of subjects in period 2 [2]
    		RTV-boosted ATV + 3TC
    Started
    30
    Completed
    27
    Not completed
    3
         Adverse event, non-fatal
    1
         Lost to follow-up
    2
    Notes
    [2] - 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: Although 31 participants signed the informed consent and were enrolled, one participant did not initiate treatment after screening and was therefore excluded from all baseline and outcome analyses. As a result, baseline characteristics are reported for 30 participants only.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline Analysis Period
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Analysis Period Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age of participants at baseline. Although the analysis was conducted on 30 subjects, the total number of enrolled participants was 31.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 40 (33 to 47) -
    Gender categorical
    Gender distribution of participants at baseline. One participant did not initiate treatment but is included in the total enrolled.
    Units: Subjects
        Female
    		 4 4
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    RTV-boosted ATV + 3TC
    Reporting group description
    		 Participants received ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.
    Reporting group title
    RTV-boosted ATV + 3TC
    Reporting group description
    		 Participants received ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.

    Primary: Change in Bone Mineral Density (BMD) at the lumbar spine (L1–L4) from baseline to Week 48

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    End point title
    		 Change in Bone Mineral Density (BMD) at the lumbar spine (L1–L4) from baseline to Week 48 [1]
    End point description
    The primary outcome was the mean change in BMD (g/cm²) at the lumbar spine, measured by dual-energy X-ray absorptiometry (DXA), after switching to ritonavir-boosted atazanavir plus lamivudine.
    End point type
    Primary
    End point timeframe
    Baseline to Week 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single-arm, open-label pilot study. The primary endpoint was assessed as a within-group change from baseline to Week 48 using descriptive statistics and linear regression. As there is no comparator group, no formal statistical comparison between groups was applicable.
    End point values
    		 RTV-boosted ATV + 3TC
    Number of subjects analysed
    30 [2]
    Units: g/cm²
        arithmetic mean (standard deviation)
    0.010 ( 0.030 )
    Notes
    [2] - Lumbar spine BMD
    No statistical analyses for this end point

    Primary: Change in Bone Mineral Density (BMD) at the left hip

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    End point title
    		 Change in Bone Mineral Density (BMD) at the left hip [3]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 48
    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: This is a single-arm, open-label pilot study. The primary endpoint was assessed as a within-group change from baseline to Week 48 using descriptive statistics and linear regression. As there is no comparator group, no formal statistical comparison between groups was applicable.
    End point values
    		 RTV-boosted ATV + 3TC
    Number of subjects analysed
    30 [4]
    Units: g/cm²
        arithmetic mean (standard deviation)
    0.013 ( 0.030 )
    Notes
    [4] - left hip
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to Week 48 (end of study visit)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    RTV-boosted ATV + 3TC
    Reporting group description
    		 -

    Serious adverse events
    		 RTV-boosted ATV + 3TC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RTV-boosted ATV + 3TC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
    Hepatobiliary disorders
    Hiperbilirrubinemia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2

    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.
    This pilot study had a small sample size and did not reach the planned enrollment of 45 participants. The final analysis included only 30 participants, which may limit the generalizability of the findings.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35512339
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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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