Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir (MONET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00458302
First received: April 6, 2007
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: February 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS Virus
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome Virus
Intervention: Drug: darunavir (DRV, TMC114)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
xxxxx

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Participant Flow:   Overall Study
    DRV/r+2NRTIs     DRV/r  
STARTED     129     127  
COMPLETED     109     103  
NOT COMPLETED     20     24  
Adverse Event                 4                 14  
Pregnancy                 2                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 6                 4  
Inc/Exc Criteria Not Met                 1                 1  
Study Termination By Sponsor                 1                 0  
Lost to Follow-up                 2                 0  
Unknown                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Total Total of all reporting groups

Baseline Measures
    DRV/r+2NRTIs     DRV/r     Total  
Number of Participants  
[units: participants]
  129     127     256  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     128     125     253  
>=65 years     1     2     3  
Age  
[units: years]
Mean ± Standard Deviation
  44.1  ± 9.74     43.4  ± 9.14     43.7  ± 9.43  
Gender  
[units: participants]
     
Female     22     28     50  
Male     107     99     206  
Region of Enrollment  
[units: participants]
     
AUSTRIA     9     7     16  
BELGIUM     12     12     24  
DENMARK     14     14     28  
GERMANY     14     14     28  
HUNGARY     6     5     11  
ISRAEL     1     7     8  
ITALY     11     5     16  
POLAND     9     20     29  
PORTUGAL     7     7     14  
RUSSIAN FEDERATION     9     2     11  
SPAIN     24     24     48  
SWITZERLAND     1     1     2  
UNITED KINGDOM     12     9     21  
plasma viral load [1]
[units: participants]
     
< 50     125     118     243  
50-400     4     7     11  
400-1000     0     0     0  
> 1000     0     2     2  
CD4+ cell count (absolute count)  
[units: cells/µl]
Median ( Full Range )
  579.0  
  ( 163 to 1888 )  
  571.0  
  ( 162 to 1451 )  
  573.5  
  ( 162 to 1888 )  
[1] plasma viral load (HIV-1 RNA copies/ml)



  Outcome Measures
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1.  Primary:   Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]
Measure Description Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  123     123  
Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]  
[units: participants]
  108     106  


Statistical Analysis 1 for Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Difference in proportion of response [3] -1.6
95% Confidence Interval ( -10.1 to 6.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.
[3] Other relevant estimation information:
  Difference in proportion of response DRV/r minus DRV/r+2NRTIs.



2.  Secondary:   Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]
Measure Description Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  129     127  
Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]  
[units: participants]
  110     107  


Statistical Analysis 1 for Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Difference in proportion of response [3] -1.0
95% Confidence Interval ( -9.9 to 7.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.
[3] Other relevant estimation information:
  Difference in proportion of response DRV/r minus DRV/r+2NRTIs.



3.  Secondary:   Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]
Measure Description Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144
Time Frame Week 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  121     122  
Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]  
[units: participants]
  94     88  

No statistical analysis provided for Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]



4.  Secondary:   Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]
Measure Description Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.
Time Frame Week 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  129     127  
Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]  
[units: participants]
  106     106  


Statistical Analysis 1 for Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]
Groups [1] All groups
Difference in proportion of response [2] 1.29
95% Confidence Interval ( -7.99 to 10.58 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Difference in proportion of response DRV/r minus DRV/r+2NRTIs.



5.  Secondary:   Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]   [ Time Frame: week 144 ]

Measure Type Secondary
Measure Title Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]
Measure Description Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144
Time Frame week 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  121     122  
Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]  
[units: Participants]
  102     95  

No statistical analysis provided for Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]



6.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count
Measure Description The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.
Time Frame at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  129     127  
Mean Change From Baseline in CD4+ Cell Count  
[units: number of cells/L (x10^6)]
Mean ± Standard Error
   
week 4     -16.9  ± 15.7     -32.9  ± 14.6  
week 12     -23.6  ± 14.7     -20.7  ± 15.2  
week 24     -5.4  ± 14.6     -35.8  ± 14.2  
week 36     -1.2  ± 15.8     -21.1  ± 14.3  
week 48     -19.0  ± 14.7     -15.1  ± 16.0  
week 60     -4.0  ± 14.9     -2.3  ± 14.4  
week 72     24.1  ± 16.1     -12.3  ± 14.3  
week 84     34.6  ± 17.2     -3.7  ± 15.0  
week 96     49.1  ± 15.9     54.8  ± 16.2  
week 112     106.0  ± 16.7     87.5  ± 16.2  
week 128     117.3  ± 18.3     90.4  ± 14.9  
week 144     99.3  ± 15.7     94.9  ± 15.0  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count



7.  Secondary:   Resistance Determinations   [ Time Frame: at each visit from baseline to week 144 ]

Measure Type Secondary
Measure Title Resistance Determinations
Measure Description Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.
Time Frame at each visit from baseline to week 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  129     127  
Resistance Determinations  
[units: number of participants]
   
>= 1 HIV-1 RNA > 50 copies/mL     42     48  
>= 1 successful genotype after baseline     23     31  
>= 1 IAS-USA primary PI mutations     1     1  
>= 1 DRV RAMs     0     1  
NRTI RAMs     1     0  
M184V mutation     1     0  
no primary PI, DRV, NRTI or M184 V mutations     22     30  

No statistical analysis provided for Resistance Determinations



8.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score
Measure Description The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  126     112  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score  
[units: points on a scale]
Mean ± Standard Error
   
week 48     1.7  ± 1.7     1.7  ± 2.0  
week 96     0.4  ± 1.6     3.5  ± 2.4  
week 144     0.7  ± 1.7     3.1  ± 2.4  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score



9.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale
Measure Description The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  127     115  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale  
[units: points on a scale]
Mean ± Standard Error
   
week 48     0.1  ± 0.2     -0.1  ± 0.2  
week 96     -0.1  ± 0.2     -0.1  ± 0.2  
week 144     0.1  ± 0.2     -0.1  ± 0.2  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale



10.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale
Measure Description The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  128     118  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale  
[units: points on a scale]
Mean ± Standard Error
   
week 48     0.1  ± 0.6     1.8  ± 0.7  
week 96     1.0  ± 0.5     1.3  ± 0.7  
week 144     1.4  ± 0.5     1.7  ± 0.7  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale



11.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale
Measure Description The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  127     116  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale  
[units: points on a scale]
Mean ± Standard Error
   
week 48     0.3  ± 0.8     -0.8  ± 0.7  
week 96     -0.1  ± 0.7     0.4  ± 0.9  
week 144     -0.6  ± 0.8     0.0  ± 1.0  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale



12.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale
Measure Description The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  128     118  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale  
[units: points on a scale]
Mean ± Standard Error
   
week 48     0.6  ± 0.5     1.0  ± 0.8  
week 96     0.4  ± 0.5     1.4  ± 0.9  
week 144     0.0  ± 0.5     1.0  ± 0.8  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale



13.  Secondary:   Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale   [ Time Frame: at baseline, week 48, 96 and 144 ]

Measure Type Secondary
Measure Title Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale
Measure Description The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).
Time Frame at baseline, week 48, 96 and 144  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups
  Description
DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values
    DRV/r+2NRTIs     DRV/r  
Number of Participants Analyzed  
[units: participants]
  126     115  
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale  
[units: points on a scale]
Mean ± Standard Error
   
week 48     0.4  ± 0.5     -0.2  ± 0.5  
week 96     -0.6  ± 0.5     0.8  ± 0.6  
week 144     -0.3  ± 0.5     0.6  ± 0.6  

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was not blinded and not designed to demonstrate a safety benefit to stopping nucleoside analogues.


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