Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00552240
First received: September 28, 2007
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: March 16, 2011  
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: tenofovir DF 300 mg QD
Drug: emtricitabine 200 mg QD
Drug: Nevirapine 200 mg BID
Drug: Atazanavir 300 mg
Drug: Ritonavir 100 mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 28 Sep 2007 through 23 Mar 2009 at 18 sites throughout the US. The sites were comprised of medical centers or private practice physicians.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a 28 day screening period where a genotype report was run. If patients were resistant to any of the study medication, they were not to be randomized into the study. Patients also needed to meet all inclusion/exclusion criteria in order to be eligible. 154 patients were enrolled but 2 were not treated, leaving 152 in full analysis set.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Participant Flow:   Overall Study
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
STARTED     75 [1]   77 [1]
COMPLETED     51     59  
NOT COMPLETED     24     18  
Adverse Event                 9                 9  
Protocol Violation                 1                 1  
Lost to Follow-up                 5                 6  
Withdrawal by Subject                 2                 2  
Lack of Efficacy                 6                 0  
not specified                 1                 0  
[1] Number in Full Analysis Set (FAS)



  Baseline Characteristics
  Hide Baseline Characteristics

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)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Total Total of all reporting groups

Baseline Measures
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada     Total  
Number of Participants  
[units: participants]
  75     77     152  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 10.4     35.9  ± 9.7     36.8  ± 10.1  
Gender  
[units: participants]
     
Female     10     6     16  
Male     65     71     136  
Log10 HIV viral load  
[units: copies/mL]
Mean ± Standard Deviation
  4.9  ± 0.8     4.9  ± 0.7     4.9  ± 0.8  
CD4+ count  
[units: cells/mm^3]
Mean ± Standard Deviation
  178.9  ± 105.3     183.5  ± 111.3     181.2  ± 108.0  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants With Virologic Response (VR)   [ Time Frame: baseline to week 48 ]

Measure Type Primary
Measure Title Number of Participants With Virologic Response (VR)
Measure Description VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Time Frame 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 treated patients. Early withdrawals were considered failures.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With Virologic Response (VR)  
[units: participants]
   
Responders     46     50  
Nonresponders     29     27  


Statistical Analysis 1 for Number of Participants With Virologic Response (VR)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.7142
Difference in proportion of responders [5] -0.041
95% Confidence Interval ( -0.183 to 0.101 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories
[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.



2.  Secondary:   Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Measure Description HIV viral load <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.
Time Frame 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 treated patients. Early withdrawals were considered failures.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm  
[units: Participants]
   
Responders     48     51  
Nonresponders     27     26  


Statistical Analysis 1 for Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.6479
Difference in proportion of responders [5] -0.027
95% Confidence Interval ( -0.167 to 0.113 )
[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:
  Same as for the primary analysis
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories
[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.



3.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Measure Description HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Time Frame 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.
Only includes treated patients with data in the Week 48 time window.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48  
[units: Participants]
   
Responders     42     48  
Nonresponders     2     8  


Statistical Analysis 1 for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.1477
Difference in proportion of responders [5] 0.084
95% Confidence Interval ( -0.030 to 0.197 )
[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:
  Same as for primary analysis
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories
[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.



4.  Secondary:   Number of Participants With Virologic Success (FDA Definition)   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Virologic Success (FDA Definition)
Measure Description HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Time Frame 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 treated patients.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With Virologic Success (FDA Definition)  
[units: Participants]
   
Responders     42     48  
Nonresponders     33     29  


Statistical Analysis 1 for Number of Participants With Virologic Success (FDA Definition)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.3703
Difference in proportion of responders [5] -0.067
95% Confidence Interval ( -0.215 to 0.080 )
[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:
  Same as for primary analysis
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories
[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.



5.  Secondary:   Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Measure Description Time to response whereby patients withdrawing early were censored after their withdrawal
Time Frame 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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants  
[units: days]
Median ( Inter-Quartile Range )
  57  
  ( 42 to 168 )  
  84  
  ( 56 to 173 )  


Statistical Analysis 1 for Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0314
Hazard Ratio (HR) [4] 0.666
95% Confidence Interval ( 0.460 to 0.964 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories.
[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.



6.  Secondary:   Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Measure Description No text entered.
Time Frame 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 responders

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  55     65  
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml  
[units: days]
Median ( Inter-Quartile Range )
  55  
  ( 41 to 85 )  
  84  
  ( 56 to 169 )  


Statistical Analysis 1 for Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0172
Hazard Ratio (HR) [4] 0.628
95% Confidence Interval ( 0.428 to 0.921 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Responders only

Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  Controlling for screening viral load and CD4+ categories
[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.



7.  Secondary:   Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response   [ Time Frame: baseline to week 24 and week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
Measure Description HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame baseline to week 24 and 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 treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response  
[units: Participants]
   
At week 24     1     4  
At week 48     2     9  

No statistical analysis provided for Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response



8.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 2  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     6     5  
HIV viral load ≥ 50 copies/ml     62     63  
Missing data     7     9  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment



9.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 4  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     12     10  
HIV viral load ≥ 50 copies/ml     53     62  
Missing data     10     5  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment



10.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 6  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     23     14  
HIV viral load ≥ 50 copies/ml     38     53  
Missing data     14     10  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment



11.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 8  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     34     23  
HIV viral load ≥ 50 copies/ml     25     50  
Missing data     16     4  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment



12.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 12  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     42     43  
HIV viral load ≥ 50 copies/ml     20     27  
Missing data     13     7  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment



13.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 24  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     48     61  
HIV viral load ≥ 50 copies/ml     9     5  
Missing data     18     11  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment



14.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 36  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     53     55  
HIV viral load ≥ 50 copies/ml     4     5  
Missing data     18     17  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment



15.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame 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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     42     48  
HIV viral load ≥ 50 copies/ml     2     8  
Missing data     31     21  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment



16.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 2  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     24     17  
HIV viral load ≥ 400 copies/ml     44     51  
Missing data     7     9  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment



17.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 4  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     38     31  
HIV viral load ≥ 400 copies/ml     27     41  
Missing data     10     5  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment



18.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 6  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     40     44  
HIV viral load ≥ 400 copies/ml     21     23  
Missing data     14     10  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment



19.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 8  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     48     58  
HIV viral load ≥ 400 copies/ml     11     15  
Missing data     16     4  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment



20.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 12  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     56     63  
HIV viral load ≥ 400 copies/ml     6     7  
Missing data     13     7  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment



21.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 24  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     51     63  
HIV viral load ≥ 400 copies/ml     6     3  
Missing data     18     11  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment



22.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 36  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     54     59  
HIV viral load ≥ 400 copies/ml     3     1  
Missing data     18     17  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment



23.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame 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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment  
[units: Participants]
   
HIV viral load < 400 copies/ml     43     54  
HIV viral load ≥ 400 copies/ml     1     2  
Missing data     31     21  

No statistical analysis provided for Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment



24.  Secondary:   Number of Patients With Virologic Rebound to >400 Copies/ml   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Patients With Virologic Rebound to >400 Copies/ml
Measure Description HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame 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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Patients With Virologic Rebound to >400 Copies/ml  
[units: Participants]
   
Rebound following response     2     6  
No rebound following response     55     63  

No statistical analysis provided for Number of Patients With Virologic Rebound to >400 Copies/ml



25.  Secondary:   AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
Measure Description

AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi’s sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.

Number of cases (no time-to analysis was performed due to small numbers).

Time Frame 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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death  
[units: Participants]
  1     3  

No statistical analysis provided for AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death



26.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 2.   [ Time Frame: baseline to week 2 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 2.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 2  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  64     64  
Change in CD4+ Cell Count From Baseline to Week 2.  
[units: cells/mm^3]
Mean ± Standard Deviation
  62.6  ± 80.9     61.0  ± 69.7  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 2.



27.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 4.   [ Time Frame: baseline to week 4 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 4.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 4  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  65     70  
Change in CD4+ Cell Count From Baseline to Week 4.  
[units: cells/mm^3]
Mean ± Standard Deviation
  76.4  ± 88.2     63.0  ± 72.6  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 4.



28.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 6.   [ Time Frame: baseline to week 6 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 6.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 6  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  59     62  
Change in CD4+ Cell Count From Baseline to Week 6.  
[units: cells/mm^3]
Mean ± Standard Deviation
  87.2  ± 86.0     78.4  ± 67.6  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 6.



29.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 8.   [ Time Frame: baseline to week 8 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 8.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 8  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  58     69  
Change in CD4+ Cell Count From Baseline to Week 8.  
[units: cells/mm^3]
Mean ± Standard Deviation
  111.9  ± 100.2     90.5  ± 85.2  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 8.



30.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 12.   [ Time Frame: baseline to week 12 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 12.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 12  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  62     68  
Change in CD4+ Cell Count From Baseline to Week 12.  
[units: cells/mm^3]
Mean ± Standard Deviation
  123.1  ± 109.5     102.2  ± 103.9  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 12.



31.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 24.   [ Time Frame: baseline to week 24 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 24.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 24  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  59     68  
Change in CD4+ Cell Count From Baseline to Week 24.  
[units: cells/mm^3]
Mean ± Standard Deviation
  131.8  ± 115.5     132.5  ± 86.8  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 24.



32.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 36.   [ Time Frame: baseline to week 36 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 36.
Measure Description Patients on-treatment, data within time windows
Time Frame baseline to week 36  
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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  57     61  
Change in CD4+ Cell Count From Baseline to Week 36.  
[units: cells/mm^3]
Mean ± Standard Deviation
  147.6  ± 120.7     120.5  ± 99.4  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 36.



33.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 48.   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 48.
Measure Description Patients on-treatment, data within time windows
Time Frame 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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  46     54  
Change in CD4+ Cell Count From Baseline to Week 48.  
[units: cells/mm^3]
Mean ± Standard Deviation
  155.1  ± 118.8     160.4  ± 108.7  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 48.



34.  Secondary:   Change in Fasting Plasma Total Cholesterol Level   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Fasting Plasma Total Cholesterol Level
Measure Description No text entered.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF).

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Fasting Plasma Total Cholesterol Level  
[units: mg/dl]
Mean ± Standard Deviation
  18.2  ± 26.5     13.8  ± 39.5  


Statistical Analysis 1 for Change in Fasting Plasma Total Cholesterol Level
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.7315
Median Difference (Final Values) [4] 1.8
95% Confidence Interval ( -8.4 to 11.9 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



35.  Secondary:   Change in Fasting Plasma Triglycerides Level   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Fasting Plasma Triglycerides Level
Measure Description No text entered.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Fasting Plasma Triglycerides Level  
[units: mg/dl]
Mean ± Standard Deviation
  -4.7  ± 87.6     8.4  ± 120.4  


Statistical Analysis 1 for Change in Fasting Plasma Triglycerides Level
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.3625
Median Difference (Final Values) [4] -10.6
95% Confidence Interval ( -33.4 to 12.3 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



36.  Secondary:   Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Measure Description No text entered.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level  
[units: mg/dl]
Mean ± Standard Deviation
  9.6  ± 11.8     3.5  ± 15.0  


Statistical Analysis 1 for Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0164
Mean Difference (Final Values) [4] 4.8
95% Confidence Interval ( 0.9 to 8.8 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



37.  Secondary:   Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Measure Description No text entered.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level  
[units: mg/dl]
Mean ± Standard Deviation
  8.7  ± 21.5     6.9  ± 32.2  


Statistical Analysis 1 for Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.9257
Mean Difference (Final Values) [4] 0.4
95% Confidence Interval ( -8.4 to 9.3 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



38.  Secondary:   Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Measure Description No text entered.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio  
[units: ratio]
Mean ± Standard Deviation
  -0.38  ± 0.96     -0.02  ± 1.06  


Statistical Analysis 1 for Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0375
Mean Difference (Final Values) [4] -0.33
95% Confidence Interval ( -0.64 to -0.02 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



39.  Secondary:   Change in Framingham Score   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Framingham Score
Measure Description Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient’s gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Time Frame 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 treated patients with data, Last observation carried forward (LOCF)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  67     71  
Change in Framingham Score  
[units: percent 10-year risk]
Mean ± Standard Deviation
  -0.09  ± 2.01     0.14  ± 2.66  


Statistical Analysis 1 for Change in Framingham Score
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4645
Mean Difference (Final Values) [4] -0.28
95% Confidence Interval ( -1.02 to 0.47 )
[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:
  Controlling for screening viral load and CD4+ categories
[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.



40.  Secondary:   Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Measure Description No text entered.
Time Frame 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.
Not calculated as no data on family history of cardiovascular disease were available

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  0     0  
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group          

No statistical analysis provided for Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group



41.  Secondary:   Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
Measure Description using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame 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.
Includes only treated patients with data for the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  66     68  
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48  
[units: ml/min/1.73m^2]
Mean ± Standard Deviation
  -0.06  ± 33.90     -12.81  ± 35.61  

No statistical analysis provided for Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48



42.  Secondary:   Percentage Adherence by Pill Count   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Percentage Adherence by Pill Count
Measure Description Number of pills not returned / number of treatment days in percent (%)
Time Frame 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 treated patients with data

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  71     76  
Percentage Adherence by Pill Count  
[units: percentage adherence]
Mean ± Standard Deviation
  94.3  ± 17.7     97.0  ± 8.1  

No statistical analysis provided for Percentage Adherence by Pill Count



43.  Secondary:   Number of Participants With Genotypic Resistance at the Time of Virologic Failure.   [ Time Frame: baseline to week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
Measure Description Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Time Frame 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.
Includes only treated patients with data in the specified time window

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  0     0  
Number of Participants With Genotypic Resistance at the Time of Virologic Failure.          

No statistical analysis provided for Number of Participants With Genotypic Resistance at the Time of Virologic Failure.



44.  Secondary:   Incidence of Patients With AIDS Progression at Each Visit   [ Time Frame: baseline to week 52 ]

Measure Type Secondary
Measure Title Incidence of Patients With AIDS Progression at Each Visit
Measure Description Cumulative incidence of patients with AIDS progression are shown
Time Frame baseline to week 52  
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

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Incidence of Patients With AIDS Progression at Each Visit  
[units: participants]
   
week 0     0     0  
week 2     0     0  
week 4     0     0  
week 6     0     1  
week 8     0     1  
week 12     0     2  
week 24     0     3  
week 36     0     3  
week 48     1     3  
week 50     1     3  
End of Study Visit     2     3  

No statistical analysis provided for Incidence of Patients With AIDS Progression at Each Visit



45.  Secondary:   Proportion of Patients Reporting CNS Side Effects of Any Severity   [ Time Frame: baseline to week 52 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting CNS Side Effects of Any Severity
Measure Description No text entered.
Time Frame baseline to week 52  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Proportion of Patients Reporting CNS Side Effects of Any Severity  
[units: participants]
  25     23  

No statistical analysis provided for Proportion of Patients Reporting CNS Side Effects of Any Severity



46.  Secondary:   Proportion of Patients Reporting Hepatic Events of Any Severity   [ Time Frame: baseline to week 52 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting Hepatic Events of Any Severity
Measure Description No text entered.
Time Frame baseline to week 52  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Proportion of Patients Reporting Hepatic Events of Any Severity  
[units: participants]
  5     24  

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



47.  Secondary:   Proportion of Patients Reporting Rash of Any Severity   [ Time Frame: baseline to week 52 ]

Measure Type Secondary
Measure Title Proportion of Patients Reporting Rash of Any Severity
Measure Description No text entered.
Time Frame baseline to week 52  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Proportion of Patients Reporting Rash of Any Severity  
[units: participants]
  21     19  

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



48.  Secondary:   Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities   [ Time Frame: baseline to week 52 ]

Measure Type Secondary
Measure Title Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Measure Description No text entered.
Time Frame baseline to week 52  
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 treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities  
[units: participants]
   
Grade 2 moderate     25     31  
Grade 3 severe     8     7  
Grade 4 potential lifethreatening     7     3  

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




  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
No text entered.


  More Information
  Hide More Information

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.


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


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00552240     History of Changes
Other Study ID Numbers: 1100.1512
Study First Received: September 28, 2007
Results First Received: March 16, 2011
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration