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

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

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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

Baseline Characteristics

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Arm/Group Title		Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir	Total
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
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

Outcome Measures

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1. Primary Outcome

Title	Treatment Response at Week 48
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

Outcome Measure Data

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
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

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]

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]

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)
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

Outcome Measure Data

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
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

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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing or not on treatment per visit

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing or not on treatment per visit

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing or not on treatment per visit

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS with varying numbers missing

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

All patients with virologic failure assessed for genotypic resistance

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
Description	Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
Time Frame	From baseline to Week 144

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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

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
Description	Number of patients with AE lipodystrophy
Time Frame	From baseline to Week 144

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
Description	Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
Time Frame	From baseline to Week 144

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
Description	Number of patients with AE elevated serum glucose
Time Frame	From baseline to Week 144

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Nevirapine QD+BID	Atazanvir/Ritonavir
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
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

Outcome Measure Data

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
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

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]

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]

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
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

Outcome Measure Data

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
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

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]

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	at Week 48, 96, 144

Outcome Measure Data

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
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

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]

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]

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]

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]

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]

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)
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

Outcome Measure Data

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
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)

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]

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)
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
Description	Calculations based on the MDRD algorithm.
Time Frame	From baseline to Week 48, 96, 144

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	week 148

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) defined as all randomized and treated patients.

Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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
Description	Proportion of Patients reporting rash of any severity
Time Frame	week 148

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) defined as all randomized and treated patients.

Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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
Description	Proportion of Patients reporting hepatic events of any severity
Time Frame	week 148

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) defined as all randomized and treated patients.

Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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
Description	Proportion of Patients reporting CNS (central nervous system) side effects of any severity
Time Frame	week 148

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) defined as all randomized and treated patients.

Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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
Description	Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
Time Frame	baseline to week 48, 96, 144

Outcome Measure Data

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
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
Description	Changes frombaseline apolipoprotein A1 & B
Time Frame	baseline to week 48, 96, 144

Outcome Measure Data

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
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
Description	Change of hsCRP from baseline to week 48, 96, 144
Time Frame	baseline to week 48, 96, 144

Outcome Measure Data

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
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
Description	Change of total triglycerides from baseline to week 48, 96, 144
Time Frame	baseline to week 48, 96, 144

Outcome Measure Data

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
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
Description	Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
Time Frame	baseline to week 48, 96, 144

Outcome Measure Data

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
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)

Adverse Events

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Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Time Frame	148 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
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	--/--	--/--	--/--
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
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

Limitations and Caveats

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[Not Specified]

More Information

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

EMail: clintriage.rdg@boehringer-ingelheim.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Seclén E, Soriano V, González MM, Martín-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218.

Soriano V, Arastéh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745.

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