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

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ClinicalTrials.gov Identifier: NCT00389207
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : March 26, 2012
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: nevirapine bid
Drug: nevirapine qd
Drug: atazanavir
Enrollment 576
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD) NVP 200mg BID on a background of the fixed combination Truvada® Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
Period Title: Overall Study
Started 188 [1] 188 [2] 193
Completed 125 116 152
Not Completed 63 72 41
Reason Not Completed
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
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir Total
Hide Arm/Group Description Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD) NVP 200mg BID on a background of the fixed combination Truvada® ATZ/r on a background of the fixed combination Truvada® Total of all reporting groups
Overall Number of Baseline Participants 188 188 193 569
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 188 participants 193 participants 569 participants
38.4  (9.7) 40.0  (10.5) 37.6  (9.5) 38.6  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 188 participants 193 participants 569 participants
Female
36
  19.1%
25
  13.3%
31
  16.1%
92
  16.2%
Male
152
  80.9%
163
  86.7%
162
  83.9%
477
  83.8%
Baseline HIV viral load category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 188 participants 188 participants 193 participants 569 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] 
Mean (Standard Deviation)
Unit of measure:  Log 10 Copies/mL
Number Analyzed 188 participants 188 participants 193 participants 569 participants
5.1  (0.7) 5.1  (0.6) 5.1  (0.7) 5.1  (0.7)
[1]
Measure Description: 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data
Baseline CD4+ cell count   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 188 participants 188 participants 193 participants 569 participants
183.3  (95.5) 202.9  (93.6) 193.2  (95.8) 193.2  (95.1)
[1]
Measure Description: 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data
1.Primary Outcome
Title Treatment Response at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: Patients
Number of responders 126 124 250 126
Number of non-responders 62 64 126 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.684
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.016
Confidence Interval 95%
-0.062 to 0.095
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.584
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.025
Confidence Interval 95%
-0.065 to 0.115
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.855
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.009
Confidence Interval 95%
-0.084 to 0.101
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Treatment Response at Week 48 (TLOVR Algorithm)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: Patients
Number of responders 261 142
Number of non-responders 115 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.321
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.038
Confidence Interval 95%
-0.112 to 0.037
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Patients With VL < 50 Copies/ml
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing or not on treatment per visit
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: 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
4.Secondary Outcome
Title Proportion of Patients With VL < 400 Copies/ml
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing or not on treatment per visit
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: 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
5.Secondary Outcome
Title Change in CD4+ Count From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing or not on treatment per visit
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
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)
6.Secondary Outcome
Title Change in Framingham Score From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
7.Secondary Outcome
Title Change in Mental Health Summary (MHS) Score From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
8.Secondary Outcome
Title Change in Physical Health Summary (PHS) Score From Baseline
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
9.Secondary Outcome
Title Number of Patients Hospitalized
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: 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
10.Secondary Outcome
Title Non-scheduled Physician Visits
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with varying numbers missing
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: 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
11.Secondary Outcome
Title Genotypic Resistance Associated With Virologic Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with virologic failure assessed for genotypic resistance
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 30 2
Measure Type: Number
Unit of Measure: 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
12.Secondary Outcome
Title Treatment-emergent AIDS-defining Illness
Hide Description Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
Time Frame From baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: Patients
Number with tr.-emerg. AIDS-def.illness 26 7
Number without tr.-emerg. AIDS-def.illness 350 186
13.Secondary Outcome
Title Treatment-emergent AIDS-defining Illness Leading to Death
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: Patients
Number with AIDS-def. illness leading to death 3 0
Number without AIDS-def. illness leading to death 373 193
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0403
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.461
Confidence Interval 95%
0.220 to 0.966
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Lipodystrophy
Hide Description Number of patients with AE lipodystrophy
Time Frame From baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: Patients
Number with lipodystrophy 1 1
Number without lipodystrophy 375 192
15.Secondary Outcome
Title Serum Lipid Abnormalities
Hide Description Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
Time Frame From baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: patients
Number with serum lipid abnormalities 9 4
Number without serum lipid abnormalities 367 189
16.Secondary Outcome
Title Glycaemic Abnormalities
Hide Description Number of patients with AE elevated serum glucose
Time Frame From baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 376 193
Measure Type: Number
Unit of Measure: Patients
Number with glycaemic abnormalities 0 3
Number without glycaemic abnormalities 376 190
17.Secondary Outcome
Title Treatment Response at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: participants
Number of responders 131 122 253 149
Number of non-responders 57 66 123 44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.0109
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.097
Confidence Interval 95%
-0.171 to -0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.1033
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.072
Confidence Interval 95%
-0.158 to 0.015
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.0073
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.122
Confidence Interval 95%
-0.212 to -0.033
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Treatment Response at Week 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: participants
Number of responders 121 113 234 143
Number of non-responders 67 75 142 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.0031
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.117
Confidence Interval 95%
-0.194 to -0.040
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.0365
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.096
Confidence Interval 95%
-0.186 to -0.006
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin 12% (or 0.12 as proportion)
Statistical Test of Hypothesis P-Value 0.0033
Comments Test for superiority following confirmation of non-inferiority
Method Cochran-Mantel-Haenszel
Comments Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.139
Confidence Interval 95%
-0.231 to -0.046
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: 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
20.Secondary Outcome
Title Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: 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
21.Secondary Outcome
Title Proportion of Patients With Virologic Failure at Week 48, 96, 144
Hide Description [Not Specified]
Time Frame at Week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Measure Type: Number
Unit of Measure: 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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments week 48
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.9784
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.001
Confidence Interval (2-Sided) 95%
-0.065 to 0.066
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments week 96
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.0331
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.064
Confidence Interval (2-Sided) 95%
0.005 to 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine BID, Atazanvir/Ritonavir
Comments week 144
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.0691
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.058
Confidence Interval (2-Sided) 95%
-0.005 to 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments week 48
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.4585
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -0.023
Confidence Interval (2-Sided) 95%
-0.084 to 0.038
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments week 96
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.5438
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.034 to 0.064
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nevirapine QD, Atazanvir/Ritonavir
Comments week 144
Type of Statistical Test Non-Inferiority or Equivalence
Comments H0: Difference in proportions = 0
Statistical Test of Hypothesis P-Value 0.5659
Comments [Not Specified]
Method Cochran Chi-Squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.016
Confidence Interval (2-Sided) 95%
-0.039 to 0.071
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Median (Inter-Quartile Range)
Unit of Measure: weeks
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.692
Confidence Interval 95%
0.570 to 0.839
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.630
Confidence Interval 95%
0.519 to 0.764
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Time to Loss of Virologic Response (Rebound)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Median (Inter-Quartile Range)
Unit of Measure: weeks
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1329
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.762
Confidence Interval 95%
0.535 to 1.086
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Time to Treatment Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Median (Inter-Quartile Range)
Unit of Measure: weeks
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine QD+BID, Atazanvir/Ritonavir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0444
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.731
Confidence Interval 95%
0.539 to 0.992
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
Hide Description Calculations based on the MDRD algorithm.
Time Frame From baseline to Week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nevirapine QD Nevirapine BID Nevirapine QD+BID Atazanvir/Ritonavir
Hide Arm/Group Description:
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
NVP 200mg BID on a background of the fixed combination Truvada®
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 376 193
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m^2
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)
26.Secondary Outcome
Title Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame week 148
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Measure Type: Number
Unit of Measure: participants
DAIDS 2 moderate 74 84 72
DAIDS 3 severe 30 28 39
DAIDS 4 potential lifethreatening 9 15 9
27.Secondary Outcome
Title Proportion of Patients Reporting Rash of Any Severity
Hide Description Proportion of Patients reporting rash of any severity
Time Frame week 148
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Measure Type: Number
Unit of Measure: participants
75 64 74
28.Secondary Outcome
Title Proportion of Patients Reporting Hepatic Events of Any Severity
Hide Description Proportion of Patients reporting hepatic events of any severity
Time Frame week 148
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Measure Type: Number
Unit of Measure: participants
26 24 92
29.Secondary Outcome
Title Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
Hide Description Proportion of Patients reporting CNS (central nervous system) side effects of any severity
Time Frame week 148
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all randomized and treated patients.
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Measure Type: Number
Unit of Measure: participants
41 41 37
30.Secondary Outcome
Title Change of Cholesterol Values From Baseline to Week 48, 96, 144
Hide Description Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
Time Frame baseline to week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, where only patients with corresponding laboratory values for the considered time point are considered
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
31.Secondary Outcome
Title Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
Hide Description Changes frombaseline apolipoprotein A1 & B
Time Frame baseline to week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, where only patients with corresponding laboratory values for the considered time point are considered
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Mean (Standard Deviation)
Unit of Measure: g/L
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)
32.Secondary Outcome
Title Change of hsCRP From Baseline to Week 48, 96, 144
Hide Description Change of hsCRP from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, where only patients with corresponding laboratory values for the considered time point are considered
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Mean (Standard Deviation)
Unit of Measure: mg/L
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)
33.Secondary Outcome
Title Change of Total Triglycerides From Baseline to Week 48, 96, 144
Hide Description Change of total triglycerides from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, where only patients with corresponding laboratory values for the considered time point are considered
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
34.Secondary Outcome
Title Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
Hide Description Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
Time Frame baseline to week 48, 96, 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS, where only patients with corresponding laboratory values for the considered time point are considered
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description:
NVP 400mg QD on a background of the fixed combination Truvada®
NVP 200mg BID on a background of the fixed combination Truvada®
ATZ/r on a background of the fixed combination Truvada®
Overall Number of Participants Analyzed 188 188 193
Mean (Standard Deviation)
Unit of Measure: ratio
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)
Time Frame 148 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Hide Arm/Group Description NVP 400mg QD on a background of the fixed combination Truvada® NVP 200mg BID on a background of the fixed combination Truvada® ATZ/r on a background of the fixed combination Truvada®
All-Cause Mortality
Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/188 (13.30%)   31/188 (16.49%)   27/193 (13.99%) 
Blood and lymphatic system disorders       
Anaemia  1  0/188 (0.00%)  2/188 (1.06%)  0/193 (0.00%) 
Neutropenia  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Angina pectoris  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Angina unstable  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Cardiac failure  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Myocardial infarction  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Myopericarditis  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Endocrine disorders       
Goitre  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Eye disorders       
Retinal detachment  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Gastrointestinal disorders       
Constipation  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Inguinal hernia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Peritonitis  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
General disorders       
Asthenia  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Fatigue  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Multi-organ failure  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Pain  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Puncture site haemorrhage  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Pyrexia  1  1/188 (0.53%)  3/188 (1.60%)  0/193 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Cholecystitis acute  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Cholelithiasis  1  0/188 (0.00%)  3/188 (1.60%)  0/193 (0.00%) 
Cholestasis  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Infections and infestations       
Abscess jaw  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Anal abscess  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Anogenital warts  1  0/188 (0.00%)  0/188 (0.00%)  5/193 (2.59%) 
Appendicitis  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Candida pneumonia  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Cerebral toxoplasmosis  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Cryptococcosis  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Cytomegalovirus infection  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Gastroenteritis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
H1N1 influenza  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
HIV infection  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Hepatitis A  1  0/188 (0.00%)  0/188 (0.00%)  2/193 (1.04%) 
Herpes zoster  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Meningitis viral  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Neurosyphilis  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Orchitis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Papilloma viral infection  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Pneumonia  1  2/188 (1.06%)  0/188 (0.00%)  3/193 (1.55%) 
Postoperative wound infection  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Pulmonary tuberculosis  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Salpingitis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Sepsis  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Sinusitis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Subcutaneous abscess  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Tuberculosis  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Urinary tract infection  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Injury, poisoning and procedural complications       
Drug exposure during pregnancy  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Fall  1  1/188 (0.53%)  1/188 (0.53%)  0/193 (0.00%) 
Fracture of penis  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Meniscus lesion  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Multiple injuries  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Rib fracture  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Subdural haematoma  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Upper limb fracture  1  1/188 (0.53%)  2/188 (1.06%)  0/193 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  0/188 (0.00%)  1/188 (0.53%)  1/193 (0.52%) 
Aspartate aminotransferase increased  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Blood bilirubin increased  1  0/188 (0.00%)  1/188 (0.53%)  1/193 (0.52%) 
Blood creatine phosphokinase increased  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Gamma-glutamyltransferase increased  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Haemoglobin decreased  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Transaminases increased  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Back pain  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Flank pain  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Musculoskeletal stiffness  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Myalgia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Neck pain  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Bladder neoplasm  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Bone neoplasm  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Hodgkin's disease  1  2/188 (1.06%)  2/188 (1.06%)  0/193 (0.00%) 
Kaposi's sarcoma  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Lung carcinoma cell type unspecified recurrent  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Lung neoplasm malignant  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Lymphoma  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Myelodysplastic syndrome  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Non-Hodgkin's lymphoma  1  0/188 (0.00%)  2/188 (1.06%)  0/193 (0.00%) 
Pancreatic carcinoma  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Nervous system disorders       
Carpal tunnel syndrome  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Cerebellar syndrome  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Cerebrovascular accident  1  0/188 (0.00%)  2/188 (1.06%)  0/193 (0.00%) 
Convulsion  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Epilepsy  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Headache  1  1/188 (0.53%)  0/188 (0.00%)  1/193 (0.52%) 
Hypoaesthesia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Neuralgia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Neuropathy peripheral  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Psychiatric disorders       
Alcohol abuse  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Depression  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Schizophrenia  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Suicide attempt  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Renal and urinary disorders       
Renal failure  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Renal failure acute  1  1/188 (0.53%)  1/188 (0.53%)  0/193 (0.00%) 
Reproductive system and breast disorders       
Cervical dysplasia  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Ovarian cyst ruptured  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Chronic obstructive pulmonary disease  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Cough  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Dyspnoea  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Interstitial lung disease  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Pleural effusion  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Pleurisy  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Pulmonary oedema  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  1/188 (0.53%)  0/188 (0.00%)  0/193 (0.00%) 
Surgical and medical procedures       
Breast prosthesis implantation  1  0/188 (0.00%)  1/188 (0.53%)  0/193 (0.00%) 
Mastoidectomy  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Tympanoplasty  1  0/188 (0.00%)  0/188 (0.00%)  1/193 (0.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nevirapine QD Nevirapine BID Atazanvir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   136/188 (72.34%)   141/188 (75.00%)   161/193 (83.42%) 
Eye disorders       
Ocular icterus  1  0/188 (0.00%)  0/188 (0.00%)  14/193 (7.25%) 
Gastrointestinal disorders       
Abdominal pain  1  5/188 (2.66%)  10/188 (5.32%)  15/193 (7.77%) 
Abdominal pain upper  1  9/188 (4.79%)  14/188 (7.45%)  13/193 (6.74%) 
Diarrhoea  1  29/188 (15.43%)  33/188 (17.55%)  47/193 (24.35%) 
Flatulence  1  9/188 (4.79%)  10/188 (5.32%)  9/193 (4.66%) 
Nausea  1  22/188 (11.70%)  21/188 (11.17%)  21/193 (10.88%) 
Vomiting  1  13/188 (6.91%)  15/188 (7.98%)  8/193 (4.15%) 
General disorders       
Fatigue  1  11/188 (5.85%)  11/188 (5.85%)  12/193 (6.22%) 
Influenza like illness  1  10/188 (5.32%)  6/188 (3.19%)  9/193 (4.66%) 
Pyrexia  1  14/188 (7.45%)  13/188 (6.91%)  9/193 (4.66%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/188 (0.00%)  0/188 (0.00%)  15/193 (7.77%) 
Jaundice  1  0/188 (0.00%)  0/188 (0.00%)  40/193 (20.73%) 
Infections and infestations       
Bronchitis  1  28/188 (14.89%)  19/188 (10.11%)  19/193 (9.84%) 
Gastroenteritis  1  8/188 (4.26%)  14/188 (7.45%)  8/193 (4.15%) 
Gonorrhoea  1  11/188 (5.85%)  3/188 (1.60%)  4/193 (2.07%) 
Herpes zoster  1  16/188 (8.51%)  12/188 (6.38%)  7/193 (3.63%) 
Influenza  1  21/188 (11.17%)  18/188 (9.57%)  16/193 (8.29%) 
Nasopharyngitis  1  41/188 (21.81%)  36/188 (19.15%)  40/193 (20.73%) 
Pharyngitis  1  10/188 (5.32%)  10/188 (5.32%)  12/193 (6.22%) 
Rhinitis  1  8/188 (4.26%)  7/188 (3.72%)  13/193 (6.74%) 
Sinusitis  1  13/188 (6.91%)  9/188 (4.79%)  10/193 (5.18%) 
Upper respiratory tract infection  1  6/188 (3.19%)  8/188 (4.26%)  14/193 (7.25%) 
Investigations       
Blood bilirubin increased  1  0/188 (0.00%)  1/188 (0.53%)  33/193 (17.10%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  14/188 (7.45%)  8/188 (4.26%)  11/193 (5.70%) 
Back pain  1  14/188 (7.45%)  13/188 (6.91%)  17/193 (8.81%) 
Myalgia  1  12/188 (6.38%)  10/188 (5.32%)  9/193 (4.66%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1  1/188 (0.53%)  0/188 (0.00%)  11/193 (5.70%) 
Nervous system disorders       
Headache  1  27/188 (14.36%)  24/188 (12.77%)  35/193 (18.13%) 
Psychiatric disorders       
Depression  1  16/188 (8.51%)  9/188 (4.79%)  18/193 (9.33%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  18/188 (9.57%)  22/188 (11.70%)  21/193 (10.88%) 
Oropharyngeal pain  1  6/188 (3.19%)  4/188 (2.13%)  12/193 (6.22%) 
Skin and subcutaneous tissue disorders       
Rash  1  25/188 (13.30%)  31/188 (16.49%)  23/193 (11.92%) 
Vascular disorders       
Hypertension  1  10/188 (5.32%)  9/188 (4.79%)  9/193 (4.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00389207     History of Changes
Other Study ID Numbers: 1100.1470
2005-004330-40 ( EudraCT Number: EudraCT )
First Submitted: October 17, 2006
First Posted: October 18, 2006
Results First Submitted: January 13, 2012
Results First Posted: March 26, 2012
Last Update Posted: January 27, 2014