Trial Outcomes & Findings for Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults (NCT NCT00389207)
NCT ID: NCT00389207
Last Updated: 2014-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
576 participants
Primary outcome timeframe
From baseline to Week 48
Results posted on
2014-01-27
Participant Flow
Participant milestones
| Measure |
Nevirapine QD
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
NVP 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
|
|---|---|---|---|
|
Overall Study
STARTED
|
188
|
188
|
193
|
|
Overall Study
COMPLETED
|
125
|
116
|
152
|
|
Overall Study
NOT COMPLETED
|
63
|
72
|
41
|
Reasons for withdrawal
| Measure |
Nevirapine QD
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
NVP 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
26
|
32
|
10
|
|
Overall Study
Protocol Violation
|
3
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
11
|
|
Overall Study
Other
|
17
|
23
|
9
|
Baseline Characteristics
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Baseline characteristics by cohort
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
Total
n=569 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
40.0 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
37.6 years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
38.6 years
STANDARD_DEVIATION 9.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=93 Participants
|
163 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
477 Participants
n=483 Participants
|
|
Baseline HIV viral load category
Baseline HIV viral load ≤ 100,000 copies/mL
|
71 participants
n=93 Participants
|
71 participants
n=4 Participants
|
65 participants
n=27 Participants
|
207 participants
n=483 Participants
|
|
Baseline HIV viral load category
Baseline HIV viral load > 100,000 copies/mL
|
117 participants
n=93 Participants
|
117 participants
n=4 Participants
|
128 participants
n=27 Participants
|
362 participants
n=483 Participants
|
|
Baseline log10 HIV viral load
|
5.1 log 10 Copies/mL
STANDARD_DEVIATION 0.7 • n=93 Participants
|
5.1 log 10 Copies/mL
STANDARD_DEVIATION 0.6 • n=4 Participants
|
5.1 log 10 Copies/mL
STANDARD_DEVIATION 0.7 • n=27 Participants
|
5.1 log 10 Copies/mL
STANDARD_DEVIATION 0.7 • n=483 Participants
|
|
Baseline CD4+ cell count
|
183.3 Cells/mm^3
STANDARD_DEVIATION 95.5 • n=93 Participants
|
202.9 Cells/mm^3
STANDARD_DEVIATION 93.6 • n=4 Participants
|
193.2 Cells/mm^3
STANDARD_DEVIATION 95.8 • n=27 Participants
|
193.2 Cells/mm^3
STANDARD_DEVIATION 95.1 • n=483 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 48Population: 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
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.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment Response at Week 48
Number of responders
|
126 Patients
|
124 Patients
|
250 Patients
|
126 Patients
|
|
Treatment Response at Week 48
Number of non-responders
|
62 Patients
|
64 Patients
|
126 Patients
|
67 Patients
|
SECONDARY outcome
Timeframe: From baseline to Week 48Population: FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories
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.
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment Response at Week 48 (TLOVR Algorithm)
Number of responders
|
261 Patients
|
142 Patients
|
—
|
—
|
|
Treatment Response at Week 48 (TLOVR Algorithm)
Number of non-responders
|
115 Patients
|
51 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOTPopulation: FAS with varying numbers missing or not on treatment per visit
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
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 60
|
0.959 Proportion of patients
|
0.901 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 72
|
0.965 Proportion of patients
|
0.915 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 84
|
0.972 Proportion of patients
|
0.896 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 96
|
0.98 Proportion of patients
|
0.924 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 108
|
0.964 Proportion of patients
|
0.968 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 120
|
0.976 Proportion of patients
|
0.955 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 132
|
0.971 Proportion of patients
|
0.947 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 144/EOT
|
0.952 Proportion of patients
|
0.929 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 4
|
0.107 Proportion of patients
|
0.09 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 8
|
0.304 Proportion of patients
|
0.25 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 12
|
0.515 Proportion of patients
|
0.412 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 24
|
0.842 Proportion of patients
|
0.779 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 36
|
0.907 Proportion of patients
|
0.83 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 50 Copies/ml
Proportion with VL<50 copies /mL at Week 48
|
0.931 Proportion of patients
|
0.886 Proportion of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOTPopulation: FAS with varying numbers missing or not on treatment per visit
VL \<400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 4
|
0.365 Proportion of patients
|
0.287 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 132
|
0.996 Proportion of patients
|
0.993 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 144/EOT
|
0.991 Proportion of patients
|
0.986 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 8
|
0.714 Proportion of patients
|
0.679 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 12
|
0.856 Proportion of patients
|
0.834 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 24
|
0.924 Proportion of patients
|
0.956 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 36
|
0.968 Proportion of patients
|
0.966 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 48
|
0.985 Proportion of patients
|
0.977 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 60
|
0.993 Proportion of patients
|
0.988 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 72
|
0.996 Proportion of patients
|
0.988 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 84
|
0.988 Proportion of patients
|
0.994 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 96
|
1.000 Proportion of patients
|
0.987 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 108
|
0.996 Proportion of patients
|
1.000 Proportion of patients
|
—
|
—
|
|
Proportion of Patients With VL < 400 Copies/ml
Proportion with VL<400 copies /mL at Week 120
|
1.000 Proportion of patients
|
0.994 Proportion of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOTPopulation: FAS with varying numbers missing or not on treatment per visit
Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 4
|
77.2 cells/mm^3
Standard Deviation 93.5
|
86.1 cells/mm^3
Standard Deviation 94.4
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 8
|
105.6 cells/mm^3
Standard Deviation 108.0
|
98.0 cells/mm^3
Standard Deviation 91.1
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 48
|
168.2 cells/mm^3
Standard Deviation 127.0
|
183.6 cells/mm^3
Standard Deviation 121.6
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 60
|
184.8 cells/mm^3
Standard Deviation 129.6
|
208.2 cells/mm^3
Standard Deviation 144.2
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 84
|
223.0 cells/mm^3
Standard Deviation 147.1
|
246.4 cells/mm^3
Standard Deviation 149.4
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 96
|
217.7 cells/mm^3
Standard Deviation 133.5
|
251.6 cells/mm^3
Standard Deviation 149.8
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 12
|
120.3 cells/mm^3
Standard Deviation 113.9
|
110.9 cells/mm^3
Standard Deviation 111.6
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 24
|
134.4 cells/mm^3
Standard Deviation 114.9
|
133.8 cells/mm^3
Standard Deviation 110.7
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 36
|
160.1 cells/mm^3
Standard Deviation 123.0
|
163.4 cells/mm^3
Standard Deviation 119.8
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 72
|
213.7 cells/mm^3
Standard Deviation 165.7
|
231.9 cells/mm^3
Standard Deviation 165.4
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 108
|
231.2 cells/mm^3
Standard Deviation 148.9
|
267.2 cells/mm^3
Standard Deviation 161.2
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 120
|
231.3 cells/mm^3
Standard Deviation 147.6
|
269.2 cells/mm^3
Standard Deviation 169.9
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 132
|
243.4 cells/mm^3
Standard Deviation 164.8
|
281.3 cells/mm^3
Standard Deviation 147.3
|
—
|
—
|
|
Change in CD4+ Count From Baseline
Change in CD4+ count to Week 144/EOT
|
251.0 cells/mm^3
Standard Deviation 151.6
|
285.8 cells/mm^3
Standard Deviation 164.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 48, 96 and 144/EOTPopulation: FAS with varying numbers missing
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.
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change in Framingham Score From Baseline
Change in Framingham score to Week 48
|
0.50 Units on a scale
Standard Deviation 2.79
|
0.66 Units on a scale
Standard Deviation 2.92
|
—
|
—
|
|
Change in Framingham Score From Baseline
Change in Framingham score to Week 96
|
0.93 Units on a scale
Standard Deviation 3.15
|
1.19 Units on a scale
Standard Deviation 3.25
|
—
|
—
|
|
Change in Framingham Score From Baseline
Change in Framingham score to Week 144/EOT
|
1.14 Units on a scale
Standard Deviation 3.40
|
0.82 Units on a scale
Standard Deviation 3.03
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 48, 96 and 144/EOTPopulation: FAS with varying numbers missing
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.
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change in Mental Health Summary (MHS) Score From Baseline
Change in MHS score to Week 48
|
6.09 Units on a scale
Standard Deviation 9.31
|
4.52 Units on a scale
Standard Deviation 7.84
|
—
|
—
|
|
Change in Mental Health Summary (MHS) Score From Baseline
Change in MHS score to Week 96
|
6.10 Units on a scale
Standard Deviation 9.75
|
4.89 Units on a scale
Standard Deviation 9.58
|
—
|
—
|
|
Change in Mental Health Summary (MHS) Score From Baseline
Change in MHS score to Week 144/EOT
|
4.76 Units on a scale
Standard Deviation 10.33
|
4.70 Units on a scale
Standard Deviation 10.14
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Weeks 48, 96 and 144/EOTPopulation: FAS with varying numbers missing
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.
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change in Physical Health Summary (PHS) Score From Baseline
Change in PHS score to Week 48
|
3.34 Units on a scale
Standard Deviation 7.77
|
3.35 Units on a scale
Standard Deviation 8.52
|
—
|
—
|
|
Change in Physical Health Summary (PHS) Score From Baseline
Change in PHS score to Week 96
|
3.19 Units on a scale
Standard Deviation 7.83
|
3.00 Units on a scale
Standard Deviation 7.34
|
—
|
—
|
|
Change in Physical Health Summary (PHS) Score From Baseline
Change in PHS score to Week 144/EOT
|
2.22 Units on a scale
Standard Deviation 8.77
|
3.35 Units on a scale
Standard Deviation 8.42
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOTPopulation: FAS with varying numbers missing
Cost effectiveness assessment by number of patients hospitalized
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Number of Patients Hospitalized
Number hospitalized between baseline and Week 24
|
8 Patients
|
2 Patients
|
—
|
—
|
|
Number of Patients Hospitalized
Number hospitalized between Week 24 and Week 48
|
6 Patients
|
5 Patients
|
—
|
—
|
|
Number of Patients Hospitalized
Number hospitalized between Week 48 and Week 96
|
5 Patients
|
5 Patients
|
—
|
—
|
|
Number of Patients Hospitalized
Number hospitalized between Week 96 and Wk 144/EOT
|
9 Patients
|
1 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOTPopulation: FAS with varying numbers missing
Cost effectiveness assessment by number of patients with non-scheduled physician visits
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Non-scheduled Physician Visits
Number between Week 24 and Week 48
|
45 patients
|
35 patients
|
—
|
—
|
|
Non-scheduled Physician Visits
Number between Week 48 and Week 96
|
58 patients
|
28 patients
|
—
|
—
|
|
Non-scheduled Physician Visits
Number between baseline and Week 24
|
74 patients
|
35 patients
|
—
|
—
|
|
Non-scheduled Physician Visits
Number between Week 96 and Wk 144/EOT
|
58 patients
|
35 patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 48Population: All patients with virologic failure assessed for genotypic resistance
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.
Outcome measures
| Measure |
Nevirapine QD
n=30 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=2 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Genotypic Resistance Associated With Virologic Failure
Emtricitabine-associated substitutions at Week 48
|
21 Number of substitutions
|
0 Number of substitutions
|
—
|
—
|
|
Genotypic Resistance Associated With Virologic Failure
Tenofovir-associated substitutions at Week 48
|
11 Number of substitutions
|
0 Number of substitutions
|
—
|
—
|
|
Genotypic Resistance Associated With Virologic Failure
Nevirapine-associated substitutions at Week 48
|
34 Number of substitutions
|
0 Number of substitutions
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: FAS
Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment-emergent AIDS-defining Illness
Number with tr.-emerg. AIDS-def.illness
|
26 Patients
|
7 Patients
|
—
|
—
|
|
Treatment-emergent AIDS-defining Illness
Number without tr.-emerg. AIDS-def.illness
|
350 Patients
|
186 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: FAS
Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment-emergent AIDS-defining Illness Leading to Death
Number with AIDS-def. illness leading to death
|
3 Patients
|
0 Patients
|
—
|
—
|
|
Treatment-emergent AIDS-defining Illness Leading to Death
Number without AIDS-def. illness leading to death
|
373 Patients
|
193 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: FAS
Number of patients with AE lipodystrophy
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Lipodystrophy
Number with lipodystrophy
|
1 Patients
|
1 Patients
|
—
|
—
|
|
Lipodystrophy
Number without lipodystrophy
|
375 Patients
|
192 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: FAS
Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Serum Lipid Abnormalities
Number with serum lipid abnormalities
|
9 patients
|
4 patients
|
—
|
—
|
|
Serum Lipid Abnormalities
Number without serum lipid abnormalities
|
367 patients
|
189 patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: FAS
Number of patients with AE elevated serum glucose
Outcome measures
| Measure |
Nevirapine QD
n=376 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=193 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Glycaemic Abnormalities
Number with glycaemic abnormalities
|
0 Patients
|
3 Patients
|
—
|
—
|
|
Glycaemic Abnormalities
Number without glycaemic abnormalities
|
376 Patients
|
190 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 96Population: 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
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.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment Response at Week 96
Number of responders
|
131 participants
|
122 participants
|
253 participants
|
149 participants
|
|
Treatment Response at Week 96
Number of non-responders
|
57 participants
|
66 participants
|
123 participants
|
44 participants
|
SECONDARY outcome
Timeframe: From baseline to Week 144Population: 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.
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.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Treatment Response at Week 144
Number of responders
|
121 participants
|
113 participants
|
234 participants
|
143 participants
|
|
Treatment Response at Week 144
Number of non-responders
|
67 participants
|
75 participants
|
142 participants
|
50 participants
|
SECONDARY outcome
Timeframe: at Week 24, 48, 96, 144Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
virologic rebound after CVR at Week 24
|
3 participants
|
2 participants
|
5 participants
|
5 participants
|
|
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
virologic rebound after CVR at Week 48
|
4 participants
|
5 participants
|
9 participants
|
12 participants
|
|
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
virologic rebound after CVR at Week 96
|
4 participants
|
6 participants
|
10 participants
|
10 participants
|
|
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
virologic rebound after CVR at Week 144
|
8 participants
|
9 participants
|
17 participants
|
15 participants
|
SECONDARY outcome
Timeframe: at Week 24, 48, 96, 144Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
virologic rebound after CVR at Week 24
|
2 participants
|
2 participants
|
4 participants
|
2 participants
|
|
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
virologic rebound after CVR at Week 96
|
3 participants
|
6 participants
|
9 participants
|
2 participants
|
|
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
virologic rebound after CVR at Week 48
|
3 participants
|
3 participants
|
6 participants
|
2 participants
|
|
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
virologic rebound after CVR at Week 144
|
4 participants
|
6 participants
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: at Week 48, 96, 144Population: 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
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With Virologic Failure at Week 48, 96, 144
virologic failure at Week 48
|
20 participants
|
25 participants
|
45 participants
|
25 participants
|
|
Proportion of Patients With Virologic Failure at Week 48, 96, 144
virologic failure at Week 96
|
15 participants
|
25 participants
|
40 participants
|
13 participants
|
|
Proportion of Patients With Virologic Failure at Week 48, 96, 144
virologic failure at Week 144
|
19 participants
|
28 participants
|
47 participants
|
17 participants
|
SECONDARY outcome
Timeframe: baseline to week 144Population: 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
Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Time to Treatment Response (First Confirmed VL<50 Copies/mL)
|
12.00 weeks
Interval 8.0 to 24.0
|
12.14 weeks
Interval 8.0 to 24.0
|
12.00 weeks
Interval 8.0 to 24.0
|
23.71 weeks
Interval 11.29 to 25.14
|
SECONDARY outcome
Timeframe: Baseline to week 144Population: 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
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.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Time to Loss of Virologic Response (Rebound)
|
143.86 weeks
Interval 48.43 to 144.0
|
143.21 weeks
Interval 0.0 to 144.0
|
143.71 weeks
Interval 4.29 to 144.0
|
143.00 weeks
Interval 119.29 to 144.0
|
SECONDARY outcome
Timeframe: baseline to week 144Population: 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
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
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Time to Treatment Failure
|
143.86 weeks
Interval 48.43 to 144.0
|
143.21 weeks
Interval 0.0 to 144.0
|
143.71 weeks
Interval 30.07 to 144.0
|
143.00 weeks
Interval 119.29 to 144.0
|
SECONDARY outcome
Timeframe: From baseline to Week 48, 96, 144Population: 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
Calculations based on the MDRD algorithm.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=376 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 Participants
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
change baseline to week 48 (N=143, 128, 271, 173)
|
-3.91 mL/min/1.73 m^2
Standard Deviation 13.93
|
-5.92 mL/min/1.73 m^2
Standard Deviation 17.11
|
-4.86 mL/min/1.73 m^2
Standard Deviation 15.52
|
-7.18 mL/min/1.73 m^2
Standard Deviation 15.19
|
|
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
change baseline to week 96 (N=130, 122, 252, 157)
|
-6.93 mL/min/1.73 m^2
Standard Deviation 14.33
|
-10.02 mL/min/1.73 m^2
Standard Deviation 17.37
|
-8.42 mL/min/1.73 m^2
Standard Deviation 15.92
|
-11.53 mL/min/1.73 m^2
Standard Deviation 15.59
|
|
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
change baseline to week 144 (N=163, 168, 331, 174)
|
-3.27 mL/min/1.73 m^2
Standard Deviation 20.65
|
-6.33 mL/min/1.73 m^2
Standard Deviation 17.30
|
-4.82 mL/min/1.73 m^2
Standard Deviation 19.06
|
-9.56 mL/min/1.73 m^2
Standard Deviation 17.47
|
SECONDARY outcome
Timeframe: week 148Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
DAIDS 2 moderate
|
74 participants
|
84 participants
|
72 participants
|
—
|
|
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
DAIDS 3 severe
|
30 participants
|
28 participants
|
39 participants
|
—
|
|
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
DAIDS 4 potential lifethreatening
|
9 participants
|
15 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: week 148Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
Proportion of Patients reporting rash of any severity
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients Reporting Rash of Any Severity
|
75 participants
|
64 participants
|
74 participants
|
—
|
SECONDARY outcome
Timeframe: week 148Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
Proportion of Patients reporting hepatic events of any severity
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients Reporting Hepatic Events of Any Severity
|
26 participants
|
24 participants
|
92 participants
|
—
|
SECONDARY outcome
Timeframe: week 148Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
Proportion of Patients reporting CNS (central nervous system) side effects of any severity
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
|
41 participants
|
41 participants
|
37 participants
|
—
|
SECONDARY outcome
Timeframe: baseline to week 48, 96, 144Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
total cholesterol, week 48 (N=138,122,164)
|
29.28 mg/dL
Standard Deviation 30.64
|
29.54 mg/dL
Standard Deviation 27.33
|
20.84 mg/dL
Standard Deviation 30.46
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
total cholesterol, week 96 (N=124,114,147)
|
39.17 mg/dL
Standard Deviation 33.67
|
36.87 mg/dL
Standard Deviation 30.60
|
29.99 mg/dL
Standard Deviation 31.93
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
total cholesterol, week 144 (N=154,155,160)
|
33.12 mg/dL
Standard Deviation 32.77
|
30.66 mg/dL
Standard Deviation 33.24
|
28.13 mg/dL
Standard Deviation 32.06
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
LDL-c, week 48 (N=136,117,159)
|
16.54 mg/dL
Standard Deviation 24.44
|
17.70 mg/dL
Standard Deviation 22.16
|
10.58 mg/dL
Standard Deviation 26.07
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
LDL-c, week 96 (N=119,110,145)
|
21.93 mg/dL
Standard Deviation 23.44
|
21.66 mg/dL
Standard Deviation 25.14
|
19.19 mg/dL
Standard Deviation 25.49
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
LDL-c, week 144 (N=151,150,157)
|
21.42 mg/dL
Standard Deviation 26.61
|
17.95 mg/dL
Standard Deviation 26.04
|
17.61 mg/dL
Standard Deviation 28.33
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
HDL, week 48(N=138,122,164)
|
12.06 mg/dL
Standard Deviation 9.72
|
11.59 mg/dL
Standard Deviation 10.95
|
3.49 mg/dL
Standard Deviation 9.44
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
HDL, week 96 (N=124,114,147)
|
13.86 mg/dL
Standard Deviation 10.95
|
13.33 mg/dL
Standard Deviation 12.00
|
4.74 mg/dL
Standard Deviation 10.62
|
—
|
|
Change of Cholesterol Values From Baseline to Week 48, 96, 144
HDL, week 144(N=154,155,160)
|
12.61 mg/dL
Standard Deviation 13.64
|
10.47 mg/dL
Standard Deviation 15.35
|
5.73 mg/dL
Standard Deviation 11.14
|
—
|
SECONDARY outcome
Timeframe: baseline to week 48, 96, 144Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
Changes frombaseline apolipoprotein A1 \& B
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein B, week 144 (N=144,139,148)
|
0.01 g/L
Standard Deviation 0.16
|
0.05 g/L
Standard Deviation 0.18
|
0.03 g/L
Standard Deviation 0.17
|
—
|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein A1, week 48 (N=134,121,156)
|
0.23 g/L
Standard Deviation 0.22
|
0.23 g/L
Standard Deviation 0.24
|
0.08 g/L
Standard Deviation 0.21
|
—
|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein A1, week 96 (N=115,106,141)
|
0.23 g/L
Standard Deviation 0.24
|
0.23 g/L
Standard Deviation 0.25
|
0.07 g/L
Standard Deviation 0.22
|
—
|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein A1, week 144 (N=144,140,148)
|
0.16 g/L
Standard Deviation 0.24
|
0.14 g/L
Standard Deviation 0.26
|
0.06 g/L
Standard Deviation 0.23
|
—
|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein B, week 48 (N=134,120,156)
|
0.00 g/L
Standard Deviation 0.17
|
0.03 g/L
Standard Deviation 0.16
|
0.03 g/L
Standard Deviation 0.16
|
—
|
|
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
apolipoprotein B, week 96 (N=115,106,141)
|
0.00 g/L
Standard Deviation 0.16
|
-0.00 g/L
Standard Deviation 0.17
|
0.03 g/L
Standard Deviation 0.17
|
—
|
SECONDARY outcome
Timeframe: baseline to week 48, 96, 144Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
Change of hsCRP from baseline to week 48, 96, 144
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change of hsCRP From Baseline to Week 48, 96, 144
hsCRP, week 48 (N=142,126,173)
|
-1.01 mg/L
Standard Deviation 12.53
|
-0.67 mg/L
Standard Deviation 12.71
|
-0.70 mg/L
Standard Deviation 8.61
|
—
|
|
Change of hsCRP From Baseline to Week 48, 96, 144
hsCRP, week 96 (N=128,120,157)
|
-1.54 mg/L
Standard Deviation 11.21
|
-0.79 mg/L
Standard Deviation 21.32
|
0.35 mg/L
Standard Deviation 15.19
|
—
|
|
Change of hsCRP From Baseline to Week 48, 96, 144
hsCRP, week 144 (N=160,164,174)
|
-0.09 mg/L
Standard Deviation 14.34
|
-0.02 mg/L
Standard Deviation 12.76
|
0.04 mg/L
Standard Deviation 8.20
|
—
|
SECONDARY outcome
Timeframe: baseline to week 48, 96, 144Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
Change of total triglycerides from baseline to week 48, 96, 144
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change of Total Triglycerides From Baseline to Week 48, 96, 144
total triglycerides, week 48 (N=138,120,164)
|
0.08 mg/dL
Standard Deviation 92.39
|
1.67 mg/dL
Standard Deviation 99.31
|
36.28 mg/dL
Standard Deviation 80.24
|
—
|
|
Change of Total Triglycerides From Baseline to Week 48, 96, 144
total triglycerides, week 96 (N=124,113,147)
|
9.34 mg/dL
Standard Deviation 95.66
|
5.35 mg/dL
Standard Deviation 84.92
|
30.45 mg/dL
Standard Deviation 94.99
|
—
|
|
Change of Total Triglycerides From Baseline to Week 48, 96, 144
total triglycerides, week 144 (N=153,153,159)
|
-3.46 mg/dL
Standard Deviation 77.97
|
6.11 mg/dL
Standard Deviation 80.82
|
27.11 mg/dL
Standard Deviation 85.97
|
—
|
SECONDARY outcome
Timeframe: baseline to week 48, 96, 144Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
Outcome measures
| Measure |
Nevirapine QD
n=188 Participants
Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
|
Nevirapine BID
n=188 Participants
NVP 200mg BID on a background of the fixed combination Truvada®
|
Nevirapine QD+BID
n=193 Participants
NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|---|
|
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
total triglycerides, week 48 (N=138,122,164)
|
-0.37 ratio
Standard Deviation 0.95
|
-0.33 ratio
Standard Deviation 1.05
|
0.20 ratio
Standard Deviation 0.99
|
—
|
|
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
total triglycerides, week 96 (N=124,114,147)
|
-0.22 ratio
Standard Deviation 0.93
|
-0.25 ratio
Standard Deviation 1.03
|
0.28 ratio
Standard Deviation 1.05
|
—
|
|
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
total triglycerides, week 144 (N=154,155,160)
|
-0.24 ratio
Standard Deviation 0.96
|
-0.07 ratio
Standard Deviation 1.45
|
0.17 ratio
Standard Deviation 1.05
|
—
|
Adverse Events
Nevirapine QD
Serious events: 25 serious events
Other events: 136 other events
Deaths: 0 deaths
Nevirapine BID
Serious events: 31 serious events
Other events: 141 other events
Deaths: 0 deaths
Atazanvir/Ritonavir
Serious events: 27 serious events
Other events: 161 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nevirapine QD
n=188 participants at risk
NVP 400mg QD on a background of the fixed combination Truvada®
|
Nevirapine BID
n=188 participants at risk
NVP 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 participants at risk
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/188 • 148 weeks
|
1.1%
2/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Endocrine disorders
Goitre
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Asthenia
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Fatigue
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Multi-organ failure
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Pain
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Puncture site haemorrhage
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
General disorders
Pyrexia
|
0.53%
1/188 • 148 weeks
|
1.6%
3/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/188 • 148 weeks
|
1.6%
3/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Hepatobiliary disorders
Cholestasis
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Abscess jaw
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Anal abscess
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
2.6%
5/193 • 148 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Cryptococcosis
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
H1N1 influenza
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
HIV infection
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
1.0%
2/193 • 148 weeks
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Neurosyphilis
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Orchitis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Pneumonia
|
1.1%
2/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
1.6%
3/193 • 148 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Salpingitis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Fracture of penis
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.53%
1/188 • 148 weeks
|
1.1%
2/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Investigations
Haemoglobin decreased
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.1%
2/188 • 148 weeks
|
1.1%
2/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/188 • 148 weeks
|
1.1%
2/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Cerebellar syndrome
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/188 • 148 weeks
|
1.1%
2/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Headache
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Neuralgia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Psychiatric disorders
Alcohol abuse
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Psychiatric disorders
Depression
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.53%
1/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
0.00%
0/193 • 148 weeks
|
|
Surgical and medical procedures
Mastoidectomy
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
|
Surgical and medical procedures
Tympanoplasty
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
0.52%
1/193 • 148 weeks
|
Other adverse events
| Measure |
Nevirapine QD
n=188 participants at risk
NVP 400mg QD on a background of the fixed combination Truvada®
|
Nevirapine BID
n=188 participants at risk
NVP 200mg BID on a background of the fixed combination Truvada®
|
Atazanvir/Ritonavir
n=193 participants at risk
ATZ/r on a background of the fixed combination Truvada®
|
|---|---|---|---|
|
Eye disorders
Ocular icterus
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
7.3%
14/193 • 148 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
5/188 • 148 weeks
|
5.3%
10/188 • 148 weeks
|
7.8%
15/193 • 148 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
9/188 • 148 weeks
|
7.4%
14/188 • 148 weeks
|
6.7%
13/193 • 148 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
29/188 • 148 weeks
|
17.6%
33/188 • 148 weeks
|
24.4%
47/193 • 148 weeks
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
9/188 • 148 weeks
|
5.3%
10/188 • 148 weeks
|
4.7%
9/193 • 148 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.7%
22/188 • 148 weeks
|
11.2%
21/188 • 148 weeks
|
10.9%
21/193 • 148 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
13/188 • 148 weeks
|
8.0%
15/188 • 148 weeks
|
4.1%
8/193 • 148 weeks
|
|
General disorders
Fatigue
|
5.9%
11/188 • 148 weeks
|
5.9%
11/188 • 148 weeks
|
6.2%
12/193 • 148 weeks
|
|
General disorders
Influenza like illness
|
5.3%
10/188 • 148 weeks
|
3.2%
6/188 • 148 weeks
|
4.7%
9/193 • 148 weeks
|
|
General disorders
Pyrexia
|
7.4%
14/188 • 148 weeks
|
6.9%
13/188 • 148 weeks
|
4.7%
9/193 • 148 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
7.8%
15/193 • 148 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
20.7%
40/193 • 148 weeks
|
|
Infections and infestations
Bronchitis
|
14.9%
28/188 • 148 weeks
|
10.1%
19/188 • 148 weeks
|
9.8%
19/193 • 148 weeks
|
|
Infections and infestations
Gastroenteritis
|
4.3%
8/188 • 148 weeks
|
7.4%
14/188 • 148 weeks
|
4.1%
8/193 • 148 weeks
|
|
Infections and infestations
Gonorrhoea
|
5.9%
11/188 • 148 weeks
|
1.6%
3/188 • 148 weeks
|
2.1%
4/193 • 148 weeks
|
|
Infections and infestations
Herpes zoster
|
8.5%
16/188 • 148 weeks
|
6.4%
12/188 • 148 weeks
|
3.6%
7/193 • 148 weeks
|
|
Infections and infestations
Influenza
|
11.2%
21/188 • 148 weeks
|
9.6%
18/188 • 148 weeks
|
8.3%
16/193 • 148 weeks
|
|
Infections and infestations
Nasopharyngitis
|
21.8%
41/188 • 148 weeks
|
19.1%
36/188 • 148 weeks
|
20.7%
40/193 • 148 weeks
|
|
Infections and infestations
Pharyngitis
|
5.3%
10/188 • 148 weeks
|
5.3%
10/188 • 148 weeks
|
6.2%
12/193 • 148 weeks
|
|
Infections and infestations
Rhinitis
|
4.3%
8/188 • 148 weeks
|
3.7%
7/188 • 148 weeks
|
6.7%
13/193 • 148 weeks
|
|
Infections and infestations
Sinusitis
|
6.9%
13/188 • 148 weeks
|
4.8%
9/188 • 148 weeks
|
5.2%
10/193 • 148 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
6/188 • 148 weeks
|
4.3%
8/188 • 148 weeks
|
7.3%
14/193 • 148 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/188 • 148 weeks
|
0.53%
1/188 • 148 weeks
|
17.1%
33/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
14/188 • 148 weeks
|
4.3%
8/188 • 148 weeks
|
5.7%
11/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
14/188 • 148 weeks
|
6.9%
13/188 • 148 weeks
|
8.8%
17/193 • 148 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
12/188 • 148 weeks
|
5.3%
10/188 • 148 weeks
|
4.7%
9/193 • 148 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.53%
1/188 • 148 weeks
|
0.00%
0/188 • 148 weeks
|
5.7%
11/193 • 148 weeks
|
|
Nervous system disorders
Headache
|
14.4%
27/188 • 148 weeks
|
12.8%
24/188 • 148 weeks
|
18.1%
35/193 • 148 weeks
|
|
Psychiatric disorders
Depression
|
8.5%
16/188 • 148 weeks
|
4.8%
9/188 • 148 weeks
|
9.3%
18/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
18/188 • 148 weeks
|
11.7%
22/188 • 148 weeks
|
10.9%
21/193 • 148 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
6/188 • 148 weeks
|
2.1%
4/188 • 148 weeks
|
6.2%
12/193 • 148 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
25/188 • 148 weeks
|
16.5%
31/188 • 148 weeks
|
11.9%
23/193 • 148 weeks
|
|
Vascular disorders
Hypertension
|
5.3%
10/188 • 148 weeks
|
4.8%
9/188 • 148 weeks
|
4.7%
9/193 • 148 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER