Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00389207
First received: October 17, 2006
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: January 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: nevirapine bid
Drug: nevirapine qd
Drug: atazanavir

  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
No text entered.

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
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®

Participant Flow:   Overall Study
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
STARTED     188 [1]   188 [2]   193  
COMPLETED     125     116     152  
NOT COMPLETED     63     72     41  
Adverse Event                 26                 32                 10  
Protocol Violation                 3                 1                 4  
Lost to Follow-up                 12                 9                 7  
Withdrawal by Subject                 5                 7                 11  
Not specified                 17                 23                 9  
[1] 3 patients were randomized to NVP QD but not treated and so not part of the Full Analysis Set (FAS)
[2] 4 patients were randomized to NVP BID but not treated and so are not part of the FAS



  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
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®
Total Total of all reporting groups

Baseline Measures
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir     Total  
Number of Participants  
[units: participants]
  188     188     193     569  
Age  
[units: years]
Mean ± Standard Deviation
  38.4  ± 9.7     40.0  ± 10.5     37.6  ± 9.5     38.6  ± 9.9  
Gender  
[units: participants]
       
Female     36     25     31     92  
Male     152     163     162     477  
Baseline HIV viral load category  
[units: participants]
       
Baseline HIV viral load ≤ 100,000 copies/mL     71     71     65     207  
Baseline HIV viral load > 100,000 copies/mL     117     117     128     362  
Baseline log10 HIV viral load [1]
[units: log 10 Copies/mL]
Mean ± Standard Deviation
  5.1  ± 0.7     5.1  ± 0.6     5.1  ± 0.7     5.1  ± 0.7  
Baseline CD4+ cell count [1]
[units: Cells/mm^3]
Mean ± Standard Deviation
  183.3  ± 95.5     202.9  ± 93.6     193.2  ± 95.8     193.2  ± 95.1  
[1] 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data



  Outcome Measures
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1.  Primary:   Treatment Response at Week 48   [ Time Frame: From baseline to Week 48 ]

Measure Type Primary
Measure Title Treatment Response at Week 48
Measure Description Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.
Time Frame From baseline to 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Treatment Response at Week 48  
[units: Patients]
       
Number of responders     126     124     250     126  
Number of non-responders     62     64     126     67  


Statistical Analysis 1 for Treatment Response at Week 48
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.684
Risk Difference (RD) [5] 0.016
95% Confidence Interval ( -0.062 to 0.095 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Treatment Response at Week 48
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.584
Risk Difference (RD) [5] 0.025
95% Confidence Interval ( -0.065 to 0.115 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Treatment Response at Week 48
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.855
Risk Difference (RD) [5] 0.009
95% Confidence Interval ( -0.084 to 0.101 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Treatment Response at Week 48 (TLOVR Algorithm)   [ Time Frame: From baseline to Week 48 ]

Measure Type Secondary
Measure Title Treatment Response at Week 48 (TLOVR Algorithm)
Measure Description Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.
Time Frame From baseline to 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.
FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Treatment Response at Week 48 (TLOVR Algorithm)  
[units: Patients]
   
Number of responders     261     142  
Number of non-responders     115     51  


Statistical Analysis 1 for Treatment Response at Week 48 (TLOVR Algorithm)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.321
Risk Difference (RD) [5] -0.038
95% Confidence Interval ( -0.112 to 0.037 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Proportion of Patients With VL < 50 Copies/ml   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

Measure Type Secondary
Measure Title Proportion of Patients With VL < 50 Copies/ml
Measure Description VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient
Time Frame From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT  
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.
FAS with varying numbers missing or not on treatment per visit

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Proportion of Patients With VL < 50 Copies/ml  
[units: Proportion of patients]
   
Proportion with VL<50 copies /mL at Week 4     0.107     0.09  
Proportion with VL<50 copies /mL at Week 8     0.304     0.25  
Proportion with VL<50 copies /mL at Week 12     0.515     0.412  
Proportion with VL<50 copies /mL at Week 24     0.842     0.779  
Proportion with VL<50 copies /mL at Week 36     0.907     0.83  
Proportion with VL<50 copies /mL at Week 48     0.931     0.886  
Proportion with VL<50 copies /mL at Week 60     0.959     0.901  
Proportion with VL<50 copies /mL at Week 72     0.965     0.915  
Proportion with VL<50 copies /mL at Week 84     0.972     0.896  
Proportion with VL<50 copies /mL at Week 96     0.98     0.924  
Proportion with VL<50 copies /mL at Week 108     0.964     0.968  
Proportion with VL<50 copies /mL at Week 120     0.976     0.955  
Proportion with VL<50 copies /mL at Week 132     0.971     0.947  
Proportion with VL<50 copies /mL at Week 144/EOT     0.952     0.929  

No statistical analysis provided for Proportion of Patients With VL < 50 Copies/ml



4.  Secondary:   Proportion of Patients With VL < 400 Copies/ml   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

Measure Type Secondary
Measure Title Proportion of Patients With VL < 400 Copies/ml
Measure Description VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)
Time Frame From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT  
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.
FAS with varying numbers missing or not on treatment per visit

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Proportion of Patients With VL < 400 Copies/ml  
[units: Proportion of patients]
   
Proportion with VL<400 copies /mL at Week 4     0.365     0.287  
Proportion with VL<400 copies /mL at Week 8     0.714     0.679  
Proportion with VL<400 copies /mL at Week 12     0.856     0.834  
Proportion with VL<400 copies /mL at Week 24     0.924     0.956  
Proportion with VL<400 copies /mL at Week 36     0.968     0.966  
Proportion with VL<400 copies /mL at Week 48     0.985     0.977  
Proportion with VL<400 copies /mL at Week 60     0.993     0.988  
Proportion with VL<400 copies /mL at Week 72     0.996     0.988  
Proportion with VL<400 copies /mL at Week 84     0.988     0.994  
Proportion with VL<400 copies /mL at Week 96     1.000     0.987  
Proportion with VL<400 copies /mL at Week 108     0.996     1.000  
Proportion with VL<400 copies /mL at Week 120     1.000     0.994  
Proportion with VL<400 copies /mL at Week 132     0.996     0.993  
Proportion with VL<400 copies /mL at Week 144/EOT     0.991     0.986  

No statistical analysis provided for Proportion of Patients With VL < 400 Copies/ml



5.  Secondary:   Change in CD4+ Count From Baseline   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

Measure Type Secondary
Measure Title Change in CD4+ Count From Baseline
Measure Description Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT
Time Frame From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT  
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.
FAS with varying numbers missing or not on treatment per visit

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Change in CD4+ Count From Baseline  
[units: cells/mm^3]
Mean ± Standard Deviation
   
Change in CD4+ count to Week 4     77.2  ± 93.5     86.1  ± 94.4  
Change in CD4+ count to Week 8     105.6  ± 108.0     98.0  ± 91.1  
Change in CD4+ count to Week 12     120.3  ± 113.9     110.9  ± 111.6  
Change in CD4+ count to Week 24     134.4  ± 114.9     133.8  ± 110.7  
Change in CD4+ count to Week 36     160.1  ± 123.0     163.4  ± 119.8  
Change in CD4+ count to Week 48     168.2  ± 127.0     183.6  ± 121.6  
Change in CD4+ count to Week 60     184.8  ± 129.6     208.2  ± 144.2  
Change in CD4+ count to Week 72     213.7  ± 165.7     231.9  ± 165.4  
Change in CD4+ count to Week 84     223.0  ± 147.1     246.4  ± 149.4  
Change in CD4+ count to Week 96     217.7  ± 133.5     251.6  ± 149.8  
Change in CD4+ count to Week 108     231.2  ± 148.9     267.2  ± 161.2  
Change in CD4+ count to Week 120     231.3  ± 147.6     269.2  ± 169.9  
Change in CD4+ count to Week 132     243.4  ± 164.8     281.3  ± 147.3  
Change in CD4+ count to Week 144/EOT     251.0  ± 151.6     285.8  ± 164.8  

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



6.  Secondary:   Change in Framingham Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

Measure Type Secondary
Measure Title Change in Framingham Score From Baseline
Measure Description Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.
Time Frame From baseline to Weeks 48, 96 and 144/EOT  
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.
FAS with varying numbers missing

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Change in Framingham Score From Baseline  
[units: Units on a scale]
Mean ± Standard Deviation
   
Change in Framingham score to Week 48     0.50  ± 2.79     0.66  ± 2.92  
Change in Framingham score to Week 96     0.93  ± 3.15     1.19  ± 3.25  
Change in Framingham score to Week 144/EOT     1.14  ± 3.40     0.82  ± 3.03  

No statistical analysis provided for Change in Framingham Score From Baseline



7.  Secondary:   Change in Mental Health Summary (MHS) Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

Measure Type Secondary
Measure Title Change in Mental Health Summary (MHS) Score From Baseline
Measure Description Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.
Time Frame From baseline to Weeks 48, 96 and 144/EOT  
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.
FAS with varying numbers missing

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Change in Mental Health Summary (MHS) Score From Baseline  
[units: Units on a scale]
Mean ± Standard Deviation
   
Change in MHS score to Week 48     6.09  ± 9.31     4.52  ± 7.84  
Change in MHS score to Week 96     6.10  ± 9.75     4.89  ± 9.58  
Change in MHS score to Week 144/EOT     4.76  ± 10.33     4.70  ± 10.14  

No statistical analysis provided for Change in Mental Health Summary (MHS) Score From Baseline



8.  Secondary:   Change in Physical Health Summary (PHS) Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

Measure Type Secondary
Measure Title Change in Physical Health Summary (PHS) Score From Baseline
Measure Description QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.
Time Frame From baseline to Weeks 48, 96 and 144/EOT  
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.
FAS with varying numbers missing

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Change in Physical Health Summary (PHS) Score From Baseline  
[units: Units on a scale]
Mean ± Standard Deviation
   
Change in PHS score to Week 48     3.34  ± 7.77     3.35  ± 8.52  
Change in PHS score to Week 96     3.19  ± 7.83     3.00  ± 7.34  
Change in PHS score to Week 144/EOT     2.22  ± 8.77     3.35  ± 8.42  

No statistical analysis provided for Change in Physical Health Summary (PHS) Score From Baseline



9.  Secondary:   Number of Patients Hospitalized   [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

Measure Type Secondary
Measure Title Number of Patients Hospitalized
Measure Description Cost effectiveness assessment by number of patients hospitalized
Time Frame From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT  
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.
FAS with varying numbers missing

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Number of Patients Hospitalized  
[units: Patients]
   
Number hospitalized between baseline and Week 24     8     2  
Number hospitalized between Week 24 and Week 48     6     5  
Number hospitalized between Week 48 and Week 96     5     5  
Number hospitalized between Week 96 and Wk 144/EOT     9     1  

No statistical analysis provided for Number of Patients Hospitalized



10.  Secondary:   Non-scheduled Physician Visits   [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

Measure Type Secondary
Measure Title Non-scheduled Physician Visits
Measure Description Cost effectiveness assessment by number of patients with non-scheduled physician visits
Time Frame From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT  
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.
FAS with varying numbers missing

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Non-scheduled Physician Visits  
[units: patients]
   
Number between baseline and Week 24     74     35  
Number between Week 24 and Week 48     45     35  
Number between Week 48 and Week 96     58     28  
Number between Week 96 and Wk 144/EOT     58     35  

No statistical analysis provided for Non-scheduled Physician Visits



11.  Secondary:   Genotypic Resistance Associated With Virologic Failure   [ Time Frame: From baseline to Week 48 ]

Measure Type Secondary
Measure Title Genotypic Resistance Associated With Virologic Failure
Measure Description Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.
Time Frame From baseline to 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.
All patients with virologic failure assessed for genotypic resistance

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  30     2  
Genotypic Resistance Associated With Virologic Failure  
[units: Number of substitutions]
   
Emtricitabine-associated substitutions at Week 48     21     0  
Tenofovir-associated substitutions at Week 48     11     0  
Nevirapine-associated substitutions at Week 48     34     0  

No statistical analysis provided for Genotypic Resistance Associated With Virologic Failure



12.  Secondary:   Treatment-emergent AIDS-defining Illness   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Treatment-emergent AIDS-defining Illness
Measure Description Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
Time Frame 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.
FAS

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Treatment-emergent AIDS-defining Illness  
[units: Patients]
   
Number with tr.-emerg. AIDS-def.illness     26     7  
Number without tr.-emerg. AIDS-def.illness     350     186  

No statistical analysis provided for Treatment-emergent AIDS-defining Illness



13.  Secondary:   Treatment-emergent AIDS-defining Illness Leading to Death   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Treatment-emergent AIDS-defining Illness Leading to Death
Measure Description Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.
Time Frame 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.
FAS

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Treatment-emergent AIDS-defining Illness Leading to Death  
[units: Patients]
   
Number with AIDS-def. illness leading to death     3     0  
Number without AIDS-def. illness leading to death     373     193  


Statistical Analysis 1 for Treatment-emergent AIDS-defining Illness Leading to Death
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0403
Hazard Ratio (HR) [4] 0.461
95% Confidence Interval ( 0.220 to 0.966 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Lipodystrophy   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Lipodystrophy
Measure Description Number of patients with AE lipodystrophy
Time Frame 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.
FAS

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Lipodystrophy  
[units: Patients]
   
Number with lipodystrophy     1     1  
Number without lipodystrophy     375     192  

No statistical analysis provided for Lipodystrophy



15.  Secondary:   Serum Lipid Abnormalities   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Serum Lipid Abnormalities
Measure Description Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
Time Frame 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.
FAS

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Serum Lipid Abnormalities  
[units: patients]
   
Number with serum lipid abnormalities     9     4  
Number without serum lipid abnormalities     367     189  

No statistical analysis provided for Serum Lipid Abnormalities



16.  Secondary:   Glycaemic Abnormalities   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Glycaemic Abnormalities
Measure Description Number of patients with AE elevated serum glucose
Time Frame 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.
FAS

Reporting Groups
  Description
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  376     193  
Glycaemic Abnormalities  
[units: Patients]
   
Number with glycaemic abnormalities     0     3  
Number without glycaemic abnormalities     376     190  

No statistical analysis provided for Glycaemic Abnormalities



17.  Secondary:   Treatment Response at Week 96   [ Time Frame: From baseline to Week 96 ]

Measure Type Secondary
Measure Title Treatment Response at Week 96
Measure Description Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.
Time Frame From baseline to Week 96  
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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Treatment Response at Week 96  
[units: participants]
       
Number of responders     131     122     253     149  
Number of non-responders     57     66     123     44  


Statistical Analysis 1 for Treatment Response at Week 96
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0109
Risk Difference (RD) [5] -0.097
95% Confidence Interval ( -0.171 to -0.022 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Treatment Response at Week 96
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.1033
Risk Difference (RD) [5] -0.072
95% Confidence Interval ( -0.158 to 0.015 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Treatment Response at Week 96
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0073
Risk Difference (RD) [5] -0.122
95% Confidence Interval ( -0.212 to -0.033 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.



18.  Secondary:   Treatment Response at Week 144   [ Time Frame: From baseline to Week 144 ]

Measure Type Secondary
Measure Title Treatment Response at Week 144
Measure Description Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.
Time Frame 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories.

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Treatment Response at Week 144  
[units: participants]
       
Number of responders     121     113     234     143  
Number of non-responders     67     75     142     50  


Statistical Analysis 1 for Treatment Response at Week 144
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0031
Risk Difference (RD) [5] -0.117
95% Confidence Interval ( -0.194 to -0.040 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Treatment Response at Week 144
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0365
Risk Difference (RD) [5] -0.096
95% Confidence Interval ( -0.186 to -0.006 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Treatment Response at Week 144
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.0033
Risk Difference (RD) [5] -0.139
95% Confidence Interval ( -0.231 to -0.046 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin 12% (or 0.12 as proportion)
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test for superiority following confirmation of non-inferiority
[5] Other relevant estimation information:
  No text entered.



19.  Secondary:   Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144   [ Time Frame: at Week 24, 48, 96, 144 ]

Measure Type Secondary
Measure Title Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
Measure Description The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)
Time Frame at Week 24, 48, 96, 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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144  
[units: participants]
       
virologic rebound after CVR at Week 24     3     2     5     5  
virologic rebound after CVR at Week 48     4     5     9     12  
virologic rebound after CVR at Week 96     4     6     10     10  
virologic rebound after CVR at Week 144     8     9     17     15  

No statistical analysis provided for Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144



20.  Secondary:   Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144   [ Time Frame: at Week 24, 48, 96, 144 ]

Measure Type Secondary
Measure Title Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
Measure Description The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)
Time Frame at Week 24, 48, 96, 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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144  
[units: participants]
       
virologic rebound after CVR at Week 24     2     2     4     2  
virologic rebound after CVR at Week 48     3     3     6     2  
virologic rebound after CVR at Week 96     3     6     9     2  
virologic rebound after CVR at Week 144     4     6     10     5  

No statistical analysis provided for Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144



21.  Secondary:   Proportion of Patients With Virologic Failure at Week 48, 96, 144   [ Time Frame: at Week 48, 96, 144 ]

Measure Type Secondary
Measure Title Proportion of Patients With Virologic Failure at Week 48, 96, 144
Measure Description No text entered.
Time Frame at Week 48, 96, 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Proportion of Patients With Virologic Failure at Week 48, 96, 144  
[units: participants]
       
virologic failure at Week 48     20     25     45     25  
virologic failure at Week 96     15     25     40     13  
virologic failure at Week 144     19     28     47     17  


Statistical Analysis 1 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.9784
Difference in proportions [5] 0.001
95% Confidence Interval ( -0.065 to 0.066 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 48
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.0331
Difference in proportions [5] 0.064
95% Confidence Interval ( 0.005 to 0.123 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 96
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine BID vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.0691
Difference in proportions [5] 0.058
95% Confidence Interval ( -0.005 to 0.121 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 144
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.4585
Difference in proportions [5] -0.023
95% Confidence Interval ( -0.084 to 0.038 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 48
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.5438
Difference in proportions [5] 0.015
95% Confidence Interval ( -0.034 to 0.064 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 96
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Proportion of Patients With Virologic Failure at Week 48, 96, 144
Groups [1] Nevirapine QD vs. Atazanvir/Ritonavir
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran Chi-Squared
P Value [4] 0.5659
Difference in proportions [5] 0.016
95% Confidence Interval ( -0.039 to 0.071 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  week 144
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  H0: Difference in proportions = 0
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



22.  Secondary:   Time to Treatment Response (First Confirmed VL<50 Copies/mL)   [ Time Frame: baseline to week 144 ]

Measure Type Secondary
Measure Title Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Measure Description Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response
Time Frame 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Time to Treatment Response (First Confirmed VL<50 Copies/mL)  
[units: weeks]
Median ( Inter-Quartile Range )
  12.00  
  ( 8.00 to 24.00 )  
  12.14  
  ( 8.00 to 24.00 )  
  12.00  
  ( 8.00 to 24.00 )  
  23.71  
  ( 11.29 to 25.14 )  


Statistical Analysis 1 for Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Method [2] Regression, Cox
P Value [3] 0.0002
Hazard Ratio (HR) [4] 0.692
95% Confidence Interval ( 0.570 to 0.839 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Method [2] Regression, Cox
P Value [3] <0.0001
Hazard Ratio (HR) [4] 0.630
95% Confidence Interval ( 0.519 to 0.764 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



23.  Secondary:   Time to Loss of Virologic Response (Rebound)   [ Time Frame: Baseline to week 144 ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response (Rebound)
Measure Description Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.
Time Frame 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Time to Loss of Virologic Response (Rebound)  
[units: weeks]
Median ( Inter-Quartile Range )
  143.86  
  ( 48.43 to 144.00 )  
  143.21  
  ( 0.00 to 144.00 )  
  143.71  
  ( 4.29 to 144.00 )  
  143.00  
  ( 119.29 to 144.00 )  


Statistical Analysis 1 for Time to Loss of Virologic Response (Rebound)
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Method [2] Regression, Cox
P Value [3] 0.1329
Hazard Ratio (HR) [4] 0.762
95% Confidence Interval ( 0.535 to 1.086 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



24.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to week 144 ]

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response
Time Frame 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Time to Treatment Failure  
[units: weeks]
Median ( Inter-Quartile Range )
  143.86  
  ( 48.43 to 144.00 )  
  143.21  
  ( 0.00 to 144.00 )  
  143.71  
  ( 30.07 to 144.00 )  
  143.00  
  ( 119.29 to 144.00 )  


Statistical Analysis 1 for Time to Treatment Failure
Groups [1] Nevirapine QD+BID vs. Atazanvir/Ritonavir
Method [2] Regression, Cox
P Value [3] 0.0444
Hazard Ratio (HR) [4] 0.731
95% Confidence Interval ( 0.539 to 0.992 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



25.  Secondary:   Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144   [ Time Frame: From baseline to Week 48, 96, 144 ]

Measure Type Secondary
Measure Title Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
Measure Description Calculations based on the MDRD algorithm.
Time Frame From baseline to Week 48, 96, 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.
Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Nevirapine QD+BID NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Nevirapine QD+BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     376     193  
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144  
[units: mL/min/1.73 m^2]
Mean ± Standard Deviation
       
change baseline to week 48 (N=143, 128, 271, 173)     -3.91  ± 13.93     -5.92  ± 17.11     -4.86  ± 15.52     -7.18  ± 15.19  
change baseline to week 96 (N=130, 122, 252, 157)     -6.93  ± 14.33     -10.02  ± 17.37     -8.42  ± 15.92     -11.53  ± 15.59  
change baseline to week 144 (N=163, 168, 331, 174)     -3.27  ± 20.65     -6.33  ± 17.30     -4.82  ± 19.06     -9.56  ± 17.47  

No statistical analysis provided for Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144



26.  Secondary:   Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities   [ Time Frame: week 148 ]

Measure Type Secondary
Measure Title Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Measure Description No text entered.
Time Frame week 148  
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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities  
[units: participants]
     
DAIDS 2 moderate     74     84     72  
DAIDS 3 severe     30     28     39  
DAIDS 4 potential lifethreatening     9     15     9  

No statistical analysis provided for Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities



27.  Secondary:   Proportion of Patients Reporting Rash of Any Severity   [ Time Frame: week 148 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting Rash of Any Severity
Measure Description Proportion of Patients reporting rash of any severity
Time Frame week 148  
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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Proportion of Patients Reporting Rash of Any Severity  
[units: participants]
  75     64     74  

No statistical analysis provided for Proportion of Patients Reporting Rash of Any Severity



28.  Secondary:   Proportion of Patients Reporting Hepatic Events of Any Severity   [ Time Frame: week 148 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting Hepatic Events of Any Severity
Measure Description Proportion of Patients reporting hepatic events of any severity
Time Frame week 148  
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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Proportion of Patients Reporting Hepatic Events of Any Severity  
[units: participants]
  26     24     92  

No statistical analysis provided for Proportion of Patients Reporting Hepatic Events of Any Severity



29.  Secondary:   Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity   [ Time Frame: week 148 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
Measure Description Proportion of Patients reporting CNS (central nervous system) side effects of any severity
Time Frame week 148  
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.
Full Analysis Set (FAS) defined as all randomized and treated patients.

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity  
[units: participants]
  41     41     37  

No statistical analysis provided for Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity



30.  Secondary:   Change of Cholesterol Values From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

Measure Type Secondary
Measure Title Change of Cholesterol Values From Baseline to Week 48, 96, 144
Measure Description Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
Time Frame baseline to week 48, 96, 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.
FAS, where only patients with corresponding laboratory values for the considered time point are considered

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Change of Cholesterol Values From Baseline to Week 48, 96, 144  
[units: mg/dL]
Mean ± Standard Deviation
     
total cholesterol, week 48 (N=138,122,164)     29.28  ± 30.64     29.54  ± 27.33     20.84  ± 30.46  
total cholesterol, week 96 (N=124,114,147)     39.17  ± 33.67     36.87  ± 30.60     29.99  ± 31.93  
total cholesterol, week 144 (N=154,155,160)     33.12  ± 32.77     30.66  ± 33.24     28.13  ± 32.06  
LDL-c, week 48 (N=136,117,159)     16.54  ± 24.44     17.70  ± 22.16     10.58  ± 26.07  
LDL-c, week 96 (N=119,110,145)     21.93  ± 23.44     21.66  ± 25.14     19.19  ± 25.49  
LDL-c, week 144 (N=151,150,157)     21.42  ± 26.61     17.95  ± 26.04     17.61  ± 28.33  
HDL, week 48(N=138,122,164)     12.06  ± 9.72     11.59  ± 10.95     3.49  ± 9.44  
HDL, week 96 (N=124,114,147)     13.86  ± 10.95     13.33  ± 12.00     4.74  ± 10.62  
HDL, week 144(N=154,155,160)     12.61  ± 13.64     10.47  ± 15.35     5.73  ± 11.14  

No statistical analysis provided for Change of Cholesterol Values From Baseline to Week 48, 96, 144



31.  Secondary:   Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

Measure Type Secondary
Measure Title Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
Measure Description Changes frombaseline apolipoprotein A1 & B
Time Frame baseline to week 48, 96, 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.
FAS, where only patients with corresponding laboratory values for the considered time point are considered

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144  
[units: g/L]
Mean ± Standard Deviation
     
apolipoprotein A1, week 48 (N=134,121,156)     0.23  ± 0.22     0.23  ± 0.24     0.08  ± 0.21  
apolipoprotein A1, week 96 (N=115,106,141)     0.23  ± 0.24     0.23  ± 0.25     0.07  ± 0.22  
apolipoprotein A1, week 144 (N=144,140,148)     0.16  ± 0.24     0.14  ± 0.26     0.06  ± 0.23  
apolipoprotein B, week 48 (N=134,120,156)     0.00  ± 0.17     0.03  ± 0.16     0.03  ± 0.16  
apolipoprotein B, week 96 (N=115,106,141)     0.00  ± 0.16     -0.00  ± 0.17     0.03  ± 0.17  
apolipoprotein B, week 144 (N=144,139,148)     0.01  ± 0.16     0.05  ± 0.18     0.03  ± 0.17  

No statistical analysis provided for Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144



32.  Secondary:   Change of hsCRP From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

Measure Type Secondary
Measure Title Change of hsCRP From Baseline to Week 48, 96, 144
Measure Description Change of hsCRP from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 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.
FAS, where only patients with corresponding laboratory values for the considered time point are considered

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Change of hsCRP From Baseline to Week 48, 96, 144  
[units: mg/L]
Mean ± Standard Deviation
     
hsCRP, week 48 (N=142,126,173)     -1.01  ± 12.53     -0.67  ± 12.71     -0.70  ± 8.61  
hsCRP, week 96 (N=128,120,157)     -1.54  ± 11.21     -0.79  ± 21.32     0.35  ± 15.19  
hsCRP, week 144 (N=160,164,174)     -0.09  ± 14.34     -0.02  ± 12.76     0.04  ± 8.20  

No statistical analysis provided for Change of hsCRP From Baseline to Week 48, 96, 144



33.  Secondary:   Change of Total Triglycerides From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

Measure Type Secondary
Measure Title Change of Total Triglycerides From Baseline to Week 48, 96, 144
Measure Description Change of total triglycerides from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 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.
FAS, where only patients with corresponding laboratory values for the considered time point are considered

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Change of Total Triglycerides From Baseline to Week 48, 96, 144  
[units: mg/dL]
Mean ± Standard Deviation
     
total triglycerides, week 48 (N=138,120,164)     0.08  ± 92.39     1.67  ± 99.31     36.28  ± 80.24  
total triglycerides, week 96 (N=124,113,147)     9.34  ± 95.66     5.35  ± 84.92     30.45  ± 94.99  
total triglycerides, week 144 (N=153,153,159)     -3.46  ± 77.97     6.11  ± 80.82     27.11  ± 85.97  

No statistical analysis provided for Change of Total Triglycerides From Baseline to Week 48, 96, 144



34.  Secondary:   Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

Measure Type Secondary
Measure Title Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
Measure Description Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 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.
FAS, where only patients with corresponding laboratory values for the considered time point are considered

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Measured Values
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Number of Participants Analyzed  
[units: participants]
  188     188     193  
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144  
[units: ratio]
Mean ± Standard Deviation
     
total triglycerides, week 48 (N=138,122,164)     -0.37  ± 0.95     -0.33  ± 1.05     0.20  ± 0.99  
total triglycerides, week 96 (N=124,114,147)     -0.22  ± 0.93     -0.25  ± 1.03     0.28  ± 1.05  
total triglycerides, week 144 (N=154,155,160)     -0.24  ± 0.96     -0.07  ± 1.45     0.17  ± 1.05  

No statistical analysis provided for Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00389207     History of Changes
Other Study ID Numbers: 1100.1470, 2005-004330-40
Study First Received: October 17, 2006
Results First Received: January 13, 2012
Last Updated: December 9, 2013
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Comitato Etico dell'Azienda Osp. Riuniti di Bergamo - Bergamo
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency, Bucharest
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products)