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    Clinical Trial Results:
    A Phase III, Randomised, Open- Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy

    Summary
    EudraCT number
    		 2007-003418-32
    Trial protocol
    		 GB   Outside EU/EEA  
    Global end of trial date
    16 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2018
    First version publication date
    02 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-104-0352
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00528957
    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 Trials Mailbox, Gilead Sciences International Ltd, GileadClinicalTrials@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000533-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
    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
    28 Dec 2006
    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
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    Panama: 72
    Worldwide total number of subjects
    97
    EEA total number of subjects
    3
    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)
    92
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.

    Pre-assignment
    Screening details
    		 127 participants were screened.

    Period 1
    Period 1 title
    Randomized Phase (Baseline to Week 48)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tenofovir DF
    Arm description
    		 Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Arm title
    		 Stavudine or Zidovudine
    Arm description
    		 Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zidovudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Zidovudine as prescribed by the investigator prior to study entry (pediatric participants < 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily)

    Investigational medicinal product name
    Stavudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m^2 every 8 hours; pediatric participants > 12 years of age: 300 mg twice daily)

    Number of subjects in period 1
    		Tenofovir DF Stavudine or Zidovudine
    Started
    48
    49
    Completed
    44
    48
    Not completed
    4
    1
         Withdrew Consent
    2
    1
         Safety, Tolerability, or Efficacy Reason
    2
    -
    Period 2
    Period 2 title
    First Extension (Week 48 to Week 144)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tenofovir DF
    Arm description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Arm title
    		 Stavudine or Zidovudine
    Arm description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Number of subjects in period 2 [1]
    		Tenofovir DF Stavudine or Zidovudine
    Started
    38
    41
    Completed
    35
    40
    Not completed
    3
    1
         Withdrew Consent
    -
    1
         Investigator's Discretion
    2
    -
         Safety, Tolerability, or Efficacy Reason
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 13 participants (6 from TDF; 7 from Stavudine or Zidovudine) completed the 48-week randomized phase and did not enroll in the first extension.
    Period 3
    Period 3 title
    Second Extension (Week 144 to Week 240)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tenofovir DF
    Arm description
    		 Participants in this group received TDF after receiving TDF in the randomized phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Arm title
    		 Stavudine or Zidovudine
    Arm description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Number of subjects in period 3 [2]
    		Tenofovir DF Stavudine or Zidovudine
    Started
    34
    40
    Completed
    27
    37
    Not completed
    7
    3
         Investigator's Discretion
    3
    -
         Safety, Tolerability, or Efficacy Reason
    4
    3
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant from the TDF group completed the first extension and did not enroll in the second extension.
    Period 4
    Period 4 title
    Third Extension (Week 240 to Week 336)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tenofovir DF
    Arm description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Arm title
    		 Stavudine or Zidovudine
    Arm description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Number of subjects in period 4
    		Tenofovir DF Stavudine or Zidovudine
    Started
    27
    37
    Completed
    21
    27
    Not completed
    6
    10
         Withdrew Consent
    -
    1
         = 18 yr old & TDF approved in adults
    1
    1
         Investigator's Discretion
    -
    1
         Lost to follow-up
    -
    3
         Safety, Tolerability, or Efficacy Reason
    5
    4
    Period 5
    Period 5 title
    Long-Term Extension (Week 336 and On)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tenofovir DF
    Arm description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Arm title
    		 Stavudine or Zidovudine
    Arm description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Oral powder, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg tablets for participants > 37 kg; 8 mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg

    Number of subjects in period 5 [3]
    		Tenofovir DF Stavudine or Zidovudine
    Started
    19
    25
    Completed
    9
    8
    Not completed
    10
    17
         Withdrew Consent
    2
    1
         Rolled Over to Study GS-US-311-1269
    4
    10
         Investigator's Discretion
    1
    1
         Safety, Tolerability, or Efficacy Reason
    3
    5
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 4 participants (2 from TDF; 2 from Stavudine or Zidovudine) completed the third extension and did not enroll in the long-term extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks).

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).

    Reporting group values
    		 Tenofovir DF Stavudine or Zidovudine Total
    Number of subjects
    		 48 49 97
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7 ± 3.3 7 ± 2.6 -
    Gender categorical
    Units: Subjects
        Female
    		 27 20 47
        Male
    		 21 29 50
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 35 42 77
        Not Hispanic or Latino
    		 13 7 20
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 13 6 19
        White
    		 3 6 9
        Mestizo
    		 28 37 65
        Native Indian (Kuna)
    		 1 0 1
    Plasma HIV-1 RNA
    Units: Subjects
        < 50 copies/ mL
    		 36 41 77
        50 to < 400 copies/mL
    		 11 6 17
        400 to < 1000 copies/ mL
    		 1 1 2
        ≥ 1000 copies/mL
    		 0 1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 118 ± 19.8 119 ± 16.7 -
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 17.59 ± 3.680 16.59 ± 1.762 -
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 25.9 ± 12.03 24.1 ± 7.77 -
    CD4 Cell Count
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    		 1190 ± 541.7 1144 ± 388.4 -
    CD4 Percentage
    Units: percentage
        arithmetic mean (standard deviation)
    		 33.9 ± 7.44 33.0 ± 6.82 -

    End points

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    End points reporting groups
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks).

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received TDF after receiving TDF in the randomized phase.

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received TDF after receiving TDF during the randomized phase.

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received TDF after receiving stavudine or zidovudine during the randomized phase.

    Subject analysis set title
    (Stavudine or Zidovudine)/TDF
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).

    Subject analysis set title
    All TDF
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants who received tenofovir DF in the randomized and/or extension phases

    Primary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. The Intent-to-Treat (ITT) Analysis Set included all participants who were randomized and received at least one dose of study drug. Missing = Failure.
    End point type
    Primary
    End point timeframe
    48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Number of subjects analysed
    48
    49
    89
    Units: percentage of participants
        number (not applicable)
    83.3
    91.8
    85.4
    Statistical analysis title
    		 Statistical Analysis - TDF vs Stavudine/Zidovudine
    Statistical analysis description
    The statistical hypotheses for the primary endpoint was as follows: • Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations < 400 copies/mL at Week 48. • Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
    Comparison groups
    Tenofovir DF v Stavudine or Zidovudine
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentages between groups
    Point estimate
    -8.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.5
         upper limit
    		 4.5
    Notes
    [1] - In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at −15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.

    Secondary: Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)

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    End point title
    		 Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
    End point description
    This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. Participants from the Intent-to-Treat (ITT) Analysis Set who were less than 12 years of age at baseline were analyzed. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine
    Number of subjects analysed
    44
    48
    Units: percentage of participants
        number (not applicable)
    88.6
    89.6
    Statistical analysis title
    		 Virologic Success at 48 Weeks
    Statistical analysis description
    In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at −15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
    Comparison groups
    Tenofovir DF v Stavudine or Zidovudine
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentages between groups
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.7
         upper limit
    		 11.8
    Notes
    [2] - The difference between the two proportions and its CI were based on normal approximation methods.

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    96 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    38
    41
    79
    Units: percentage of participants
        number (not applicable)
    81.6
    85.4
    83.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    38
    40
    78
    Units: percentage of participants
        number (not applicable)
    73.7
    87.5
    80.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    192 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    34
    40
    74
    Units: percentage of participants
        number (not applicable)
    70.6
    82.5
    77.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    240 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    34
    37
    71
    Units: percentage of participants
        number (not applicable)
    70.6
    75.7
    73.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    288 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    27
    37
    64
    Units: percentage of participants
        number (not applicable)
    81.5
    67.6
    73.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    336 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    22
    21
    43
    Units: percentage of participants
        number (not applicable)
    90.9
    100.0
    95.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    384 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    17
    9
    26
    Units: percentage of participants
        number (not applicable)
    100.0
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    432 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    13
    7
    20
    Units: percentage of participants
        number (not applicable)
    100.0
    85.7
    95.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    480 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    9
    2
    11
    Units: percentage of participants
        number (not applicable)
    88.9
    100.0
    90.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    528 weeks
    End point values
    		 Tenofovir DF All TDF
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (not applicable)
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Number of subjects analysed
    48
    49
    89
    Units: percentage of participants
        number (not applicable)
    70.8
    85.7
    68.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    96 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    38
    41
    79
    Units: percentage of participants
        number (not applicable)
    76.3
    68.3
    72.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    38
    40
    78
    Units: percentage of participants
        number (not applicable)
    63.2
    75.0
    69.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    192 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    34
    40
    74
    Units: percentage of participants
        number (not applicable)
    67.6
    75.0
    71.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    240 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    34
    37
    71
    Units: percentage of participants
        number (not applicable)
    70.6
    73.0
    71.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
    End point type
    Secondary
    End point timeframe
    288 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    27
    37
    64
    Units: percentage of participants
        number (not applicable)
    81.5
    62.2
    70.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    336 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    22
    21
    43
    Units: percentage of participants
        number (not applicable)
    86.4
    90.5
    88.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    384 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    17
    9
    26
    Units: percentage of participants
        number (not applicable)
    88.2
    100.0
    92.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    432 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    13
    7
    20
    Units: percentage of participants
        number (not applicable)
    100.0
    71.4
    90.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    480 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    9
    2
    11
    Units: percentage of participants
        number (not applicable)
    77.8
    50.0
    72.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
    End point description
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    528 weeks
    End point values
    		 Tenofovir DF All TDF
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (not applicable)
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 48 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 48 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Number of subjects analysed
    46
    48
    86
    Units: percentage
        arithmetic mean (standard deviation)
    0.3 ± 4.49
    1.1 ± 4.73
    0.6 ± 3.85
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 96 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 96 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 96 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    37
    38
    75
    Units: percentage
        arithmetic mean (standard deviation)
    1.3 ± 4.08
    -0.1 ± 3.60
    0.6 ± 3.88
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 144 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 144 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 144 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    33
    38
    71
    Units: percentage
        arithmetic mean (standard deviation)
    0.8 ± 5.61
    -0.1 ± 3.83
    0.3 ± 4.73
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 192 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 192 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 192 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    29
    37
    66
    Units: percentage
        arithmetic mean (standard deviation)
    1.1 ± 5.57
    0.6 ± 3.69
    0.8 ± 4.58
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 240 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 240 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 240 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    28
    32
    60
    Units: percentage
        arithmetic mean (standard deviation)
    1.3 ± 5.98
    -0.9 ± 4.13
    0.1 ± 5.16
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 288 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 288 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 288 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    26
    26
    52
    Units: percentage
        arithmetic mean (standard deviation)
    2.0 ± 6.30
    0.5 ± 4.77
    1.3 ± 5.58
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 336 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 336 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 336 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    23
    22
    45
    Units: percentage
        arithmetic mean (standard deviation)
    2.0 ± 7.19
    0.8 ± 4.01
    1.4 ± 5.82
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 384 Weeks

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Percentage at 384 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 384 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    19
    10
    29
    Units: percentage
        arithmetic mean (standard deviation)
    0.5 ± 7.80
    1.6 ± 1.90
    0.9 ± 6.37
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 432 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 432 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 432 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    14
    7
    21
    Units: percentage
        arithmetic mean (standard deviation)
    0.3 ± 6.41
    2.9 ± 3.53
    1.1 ± 5.66
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 480 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 480 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 480 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    10
    3
    13
    Units: percentage
        arithmetic mean (standard deviation)
    2.3 ± 7.15
    5.0 ± 10.00
    2.9 ± 7.51
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at 528 Weeks

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    End point title
    		 Change From Baseline in CD4 Percentage at 528 Weeks
    End point description
    This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 528 weeks
    End point values
    		 Tenofovir DF All TDF
    Number of subjects analysed
    6
    6
    Units: percentage
        arithmetic mean (standard deviation)
    4.5 ± 3.89
    4.5 ± 3.89
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Number of subjects analysed
    46
    48
    86
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -97 ± 416.4
    -11 ± 280.2
    2 ± 385.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 96 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    37
    37
    74
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -77 ± 408.3
    -56 ± 305.6
    -67 ± 358.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 144 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    33
    38
    71
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -139 ± 438.2
    -146 ± 245.3
    -142 ± 345.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 192 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    29
    37
    66
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -304 ± 529.0
    -177 ± 288.5
    -233 ± 413.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 240 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    27
    32
    59
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -369 ± 529.9
    -296 ± 252.6
    -329 ± 401.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 288 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    26
    25
    51
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -346 ± 507.5
    -256 ± 292.5
    -302 ± 414.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 336 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    23
    22
    45
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -415 ± 569.4
    -283 ± 252.2
    -350 ± 443.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 384 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    19
    10
    29
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -620 ± 635.6
    -305 ± 238.2
    -512 ± 548.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 432 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    14
    7
    21
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -795 ± 559.2
    -302 ± 355.2
    -631 ± 545.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 480 weeks
    End point values
    		 Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
    Number of subjects analysed
    10
    3
    13
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -923 ± 755.4
    -448 ± 469.9
    -813 ± 712.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks

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    End point title
    		 Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
    End point description
    This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. Intent-to-treat, Missing = Excluded
    End point type
    Secondary
    End point timeframe
    Baseline and 528 weeks
    End point values
    		 Tenofovir DF All TDF
    Number of subjects analysed
    6
    6
    Units: cells/mm^3
        arithmetic mean (standard deviation)
    -710 ± 447.0
    -710 ± 447.0
    No statistical analyses for this end point

    Secondary: Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)

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    End point title
    		 Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
    End point description
    This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. Participants from the Intent-to-Treat (ITT) Analysis Set who were less than 12 years of age at baseline were analyzed. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Tenofovir DF Stavudine or Zidovudine
    Number of subjects analysed
    44
    48
    Units: percentage of participants
        number (not applicable)
    75.0
    81.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were reported in the open-label randomized period (Weeks 0-48), and during the extension period when all participants received tenofovir DF.
    Adverse event reporting additional description
    Tenofovir DF and Stavudine or Zidovudine groups: AEs were reported from baseline through last dose (up to Week 48) + 30 days. AEs with onset during the extension period were excluded; All TDF group: AEs were reported from baseline through last dose + 30 days (median duration of exposure = 330.7 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Tenofovir DF
    Reporting group description
    		 Participants in this group received TDF during the randomized phase (48 weeks).

    Reporting group title
    Stavudine or Zidovudine
    Reporting group description
    		 Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).

    Reporting group title
    All TDF
    Reporting group description
    		 All participants who received tenofovir DF in the randomized and/or extension phases

    Serious adverse events
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 49 (4.08%)
    15 / 89 (16.85%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymph node abscess
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tenofovir DF Stavudine or Zidovudine All TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 48 (77.08%)
    35 / 49 (71.43%)
    82 / 89 (92.13%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    14 / 89 (15.73%)
         occurrences all number
    1
    0
    16
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    8 / 89 (8.99%)
         occurrences all number
    0
    0
    11
    Anaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    6 / 89 (6.74%)
         occurrences all number
    0
    0
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 49 (6.12%)
    14 / 89 (15.73%)
         occurrences all number
    1
    4
    25
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 49 (2.04%)
    20 / 89 (22.47%)
         occurrences all number
    5
    1
    28
    Dental caries
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 49 (2.04%)
    22 / 89 (24.72%)
         occurrences all number
    1
    1
    26
    Vomiting
         subjects affected / exposed
    6 / 48 (12.50%)
    0 / 49 (0.00%)
    11 / 89 (12.36%)
         occurrences all number
    6
    0
    15
    Gastritis
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 49 (2.04%)
    8 / 89 (8.99%)
         occurrences all number
    2
    1
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 48 (12.50%)
    7 / 49 (14.29%)
    20 / 89 (22.47%)
         occurrences all number
    7
    8
    35
    Rhinitis allergic
         subjects affected / exposed
    4 / 48 (8.33%)
    0 / 49 (0.00%)
    12 / 89 (13.48%)
         occurrences all number
    4
    0
    19
    Nasal congestion
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 49 (4.08%)
    8 / 89 (8.99%)
         occurrences all number
    0
    2
    10
    Asthmatic crisis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    5 / 89 (5.62%)
         occurrences all number
    0
    1
    15
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    8 / 89 (8.99%)
         occurrences all number
    0
    0
    8
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 49 (2.04%)
    5 / 89 (5.62%)
         occurrences all number
    1
    1
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    15 / 89 (16.85%)
         occurrences all number
    0
    1
    23
    Myalgia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    6 / 89 (6.74%)
         occurrences all number
    0
    0
    7
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    17 / 48 (35.42%)
    17 / 49 (34.69%)
    57 / 89 (64.04%)
         occurrences all number
    28
    25
    221
    Otitis media
         subjects affected / exposed
    7 / 48 (14.58%)
    4 / 49 (8.16%)
    16 / 89 (17.98%)
         occurrences all number
    9
    5
    36
    Gastroenteritis
         subjects affected / exposed
    3 / 48 (6.25%)
    4 / 49 (8.16%)
    18 / 89 (20.22%)
         occurrences all number
    3
    4
    21
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 48 (12.50%)
    4 / 49 (8.16%)
    10 / 89 (11.24%)
         occurrences all number
    6
    5
    25
    Pharyngitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    16 / 89 (17.98%)
         occurrences all number
    1
    0
    21
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 49 (2.04%)
    14 / 89 (15.73%)
         occurrences all number
    1
    1
    16
    Impetigo
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 49 (4.08%)
    10 / 89 (11.24%)
         occurrences all number
    0
    3
    14
    Oral herpes
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 49 (2.04%)
    9 / 89 (10.11%)
         occurrences all number
    2
    1
    18
    Varicella
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    10 / 89 (11.24%)
         occurrences all number
    0
    1
    10
    Tinea versicolour
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 49 (2.04%)
    8 / 89 (8.99%)
         occurrences all number
    1
    1
    10
    Bronchitis
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 49 (2.04%)
    6 / 89 (6.74%)
         occurrences all number
    2
    1
    6
    Conjunctivitis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 49 (0.00%)
    7 / 89 (7.87%)
         occurrences all number
    2
    0
    7
    Sinusitis
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 49 (2.04%)
    5 / 89 (5.62%)
         occurrences all number
    4
    1
    8
    Acarodermatitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    8 / 89 (8.99%)
         occurrences all number
    0
    0
    8
    Abscess limb
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 49 (2.04%)
    5 / 89 (5.62%)
         occurrences all number
    1
    1
    6
    Fungal skin infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    6 / 89 (6.74%)
         occurrences all number
    0
    0
    8
    Lice infestation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    5 / 89 (5.62%)
         occurrences all number
    0
    1
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Aug 2006
    — The planned number of study centers was increased from 1 in Panama to up to 10 in the US and Panama. — The planned number of subjects was increased from 60 (30 per treatment group) to 100 (50 per treatment group). — Administrative clarifications to the protocol were made regarding dispensing of study medication to subjects and requirements for study entry.
    14 Jun 2007
    — The study was extended for an additional 2 years. After completing 48 weeks of treatment with study drug or stavudine or zidovudine, eligible subjects from both study groups were given the option to continue (or initiate) tenofovir DF by rolling over into a 96-week study extension. — The study was expanded into the UK.
    07 Aug 2009
    — The study was extended for an additional 2 years. After completing the first 96-week study extension with open-label tenofovir DF, currently enrolled subjects at all active sites who have not yet reached 18 years of age (only applicable where tenofovir DF is commercially available for the treatment of HIV-1 infection in adults) and who have shown benefit from tenofovir DF will be given the option to continue receiving tenofovir DF for an additional 96 weeks, or until tenofovir DF becomes commercially available in the country in which the subjects are enrolled, whichever occurs first.
    13 May 2011
    — The study was extended to include a third 96-week open-label extension for a total of up to 336 weeks. — The interval for DXA scans was increased from every 24 weeks to every 48 weeks after Week 240.
    23 Jan 2012
    — Reduced-strength TDF tablets (150, 200, and 250 mg) were added. — A Week 4 visit was added after the switch from TDF powder to TDF tablets. — The US Food and Drug Administration (FDA) snapshot algorithm was added as a secondary efficacy endpoint.
    13 Feb 2013
    — A long term extension period was introduced (ie, beyond Week 336).

    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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