HIV Infections
Conditions
Brief summary
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF). All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic abnormalities.
Interventions
DRUGnevirapine bid
nevirapine twice daily
DRUGnevirapine qd
nevirapine once daily
DRUGatazanavir
atazanavir once daily
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation 2. HIV-1-infected males or females \>= 18 years of age with positive serology confirmed by Western blot 3. No previous antiretroviral treatment (of more than 7 days) 4. Males with CD4+ counts of \< 400 cells/mm3 and females with CD4+ counts of \< 250 cells/mm3 5. NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report 6. Adequate renal function defined as a calculated creatinine clearance (CLCr) \>= 50 ml/min according to the Cockcroft-Gault formula 7. Karnofsky score \>= 70 8. Acceptable medical history, as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response at Week 48 | From baseline to Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Hospitalized | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT | Cost effectiveness assessment by number of patients hospitalized |
| Treatment Response at Week 48 (TLOVR Algorithm) | From baseline to Week 48 | 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. |
| Proportion of Patients With VL < 50 Copies/ml | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT | 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 |
| Proportion of Patients With VL < 400 Copies/ml | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT | VL \<400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) |
| Change in CD4+ Count From Baseline | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT | Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT |
| Change in Framingham Score From Baseline | From baseline to Weeks 48, 96 and 144/EOT | 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. |
| Change in Mental Health Summary (MHS) Score From Baseline | From baseline to Weeks 48, 96 and 144/EOT | 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. |
| Non-scheduled Physician Visits | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT | Cost effectiveness assessment by number of patients with non-scheduled physician visits |
| Genotypic Resistance Associated With Virologic Failure | From baseline to Week 48 | 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. |
| Treatment-emergent AIDS-defining Illness | From baseline to Week 144 | Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment |
| Treatment-emergent AIDS-defining Illness Leading to Death | From baseline to Week 144 | Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness. |
| Lipodystrophy | From baseline to Week 144 | Number of patients with AE lipodystrophy |
| Serum Lipid Abnormalities | From baseline to Week 144 | Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia) |
| Glycaemic Abnormalities | From baseline to Week 144 | Number of patients with AE elevated serum glucose |
| Treatment Response at Week 96 | From baseline to Week 96 | 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. |
| Treatment Response at Week 144 | From baseline to Week 144 | 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. |
| Change in Physical Health Summary (PHS) Score From Baseline | From baseline to Weeks 48, 96 and 144/EOT | 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. |
| Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144 | at Week 24, 48, 96, 144 | The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL) |
| Proportion of Patients With Virologic Failure at Week 48, 96, 144 | at Week 48, 96, 144 | — |
| Time to Treatment Response (First Confirmed VL<50 Copies/mL) | baseline to week 144 | Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response |
| Time to Loss of Virologic Response (Rebound) | Baseline to week 144 | 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 to Treatment Failure | baseline to week 144 | 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 |
| Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | From baseline to Week 48, 96, 144 | Calculations based on the MDRD algorithm. |
| Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | week 148 | — |
| Proportion of Patients Reporting Rash of Any Severity | week 148 | Proportion of Patients reporting rash of any severity |
| Proportion of Patients Reporting Hepatic Events of Any Severity | week 148 | Proportion of Patients reporting hepatic events of any severity |
| Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity | week 148 | Proportion of Patients reporting CNS (central nervous system) side effects of any severity |
| Change of Cholesterol Values From Baseline to Week 48, 96, 144 | baseline to week 48, 96, 144 | Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL |
| Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | baseline to week 48, 96, 144 | Changes frombaseline apolipoprotein A1 & B |
| Change of hsCRP From Baseline to Week 48, 96, 144 | baseline to week 48, 96, 144 | Change of hsCRP from baseline to week 48, 96, 144 |
| Change of Total Triglycerides From Baseline to Week 48, 96, 144 | baseline to week 48, 96, 144 | Change of total triglycerides from baseline to week 48, 96, 144 |
| Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | baseline to week 48, 96, 144 | Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144 |
| Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144 | at Week 24, 48, 96, 144 | The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL) |
Countries
Argentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD) | 188 |
| Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada® | 188 |
| Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada® | 193 |
| Total | 569 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 26 | 32 | 10 |
| Overall Study | Lost to Follow-up | 12 | 9 | 7 |
| Overall Study | Other | 17 | 23 | 9 |
| Overall Study | Protocol Violation | 3 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 7 | 11 |
Baseline characteristics
| Characteristic | Nevirapine QD | Nevirapine BID | Atazanvir/Ritonavir | Total |
|---|---|---|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 9.7 | 40.0 years STANDARD_DEVIATION 10.5 | 37.6 years STANDARD_DEVIATION 9.5 | 38.6 years STANDARD_DEVIATION 9.9 |
| Baseline CD4+ cell count | 183.3 Cells/mm^3 STANDARD_DEVIATION 95.5 | 202.9 Cells/mm^3 STANDARD_DEVIATION 93.6 | 193.2 Cells/mm^3 STANDARD_DEVIATION 95.8 | 193.2 Cells/mm^3 STANDARD_DEVIATION 95.1 |
| Baseline HIV viral load category Baseline HIV viral load ≤ 100,000 copies/mL | 71 participants | 71 participants | 65 participants | 207 participants |
| Baseline HIV viral load category Baseline HIV viral load > 100,000 copies/mL | 117 participants | 117 participants | 128 participants | 362 participants |
| Baseline log10 HIV viral load | 5.1 log 10 Copies/mL STANDARD_DEVIATION 0.7 | 5.1 log 10 Copies/mL STANDARD_DEVIATION 0.6 | 5.1 log 10 Copies/mL STANDARD_DEVIATION 0.7 | 5.1 log 10 Copies/mL STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 36 Participants | 25 Participants | 31 Participants | 92 Participants |
| Sex: Female, Male Male | 152 Participants | 163 Participants | 162 Participants | 477 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 136 / 188 | 141 / 188 | 161 / 193 |
| serious Total, serious adverse events | 25 / 188 | 31 / 188 | 27 / 193 |
Outcome results
Primary
Treatment Response at Week 48
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment Response at Week 48 | Number of responders | 126 Patients |
| Nevirapine QD | Treatment Response at Week 48 | Number of non-responders | 62 Patients |
| Nevirapine BID | Treatment Response at Week 48 | Number of non-responders | 64 Patients |
| Nevirapine BID | Treatment Response at Week 48 | Number of responders | 124 Patients |
| Nevirapine QD+BID | Treatment Response at Week 48 | Number of responders | 250 Patients |
| Nevirapine QD+BID | Treatment Response at Week 48 | Number of non-responders | 126 Patients |
| Atazanvir/Ritonavir | Treatment Response at Week 48 | Number of responders | 126 Patients |
| Atazanvir/Ritonavir | Treatment Response at Week 48 | Number of non-responders | 67 Patients |
p-value: 0.68495% CI: [-0.062, 0.095]Cochran-Mantel-Haenszel
p-value: 0.58495% CI: [-0.065, 0.115]Cochran-Mantel-Haenszel
p-value: 0.85595% CI: [-0.084, 0.101]Cochran-Mantel-Haenszel
Secondary
Change in CD4+ Count From Baseline
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
Population: FAS with varying numbers missing or not on treatment per visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 60 | 184.8 cells/mm^3 | Standard Deviation 129.6 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 108 | 231.2 cells/mm^3 | Standard Deviation 148.9 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 72 | 213.7 cells/mm^3 | Standard Deviation 165.7 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 24 | 134.4 cells/mm^3 | Standard Deviation 114.9 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 84 | 223.0 cells/mm^3 | Standard Deviation 147.1 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 8 | 105.6 cells/mm^3 | Standard Deviation 108 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 96 | 217.7 cells/mm^3 | Standard Deviation 133.5 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 36 | 160.1 cells/mm^3 | Standard Deviation 123 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 120 | 231.3 cells/mm^3 | Standard Deviation 147.6 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 4 | 77.2 cells/mm^3 | Standard Deviation 93.5 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 132 | 243.4 cells/mm^3 | Standard Deviation 164.8 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 48 | 168.2 cells/mm^3 | Standard Deviation 127 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 144/EOT | 251.0 cells/mm^3 | Standard Deviation 151.6 |
| Nevirapine QD | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 12 | 120.3 cells/mm^3 | Standard Deviation 113.9 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 144/EOT | 285.8 cells/mm^3 | Standard Deviation 164.8 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 4 | 86.1 cells/mm^3 | Standard Deviation 94.4 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 8 | 98.0 cells/mm^3 | Standard Deviation 91.1 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 12 | 110.9 cells/mm^3 | Standard Deviation 111.6 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 24 | 133.8 cells/mm^3 | Standard Deviation 110.7 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 36 | 163.4 cells/mm^3 | Standard Deviation 119.8 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 48 | 183.6 cells/mm^3 | Standard Deviation 121.6 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 60 | 208.2 cells/mm^3 | Standard Deviation 144.2 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 72 | 231.9 cells/mm^3 | Standard Deviation 165.4 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 84 | 246.4 cells/mm^3 | Standard Deviation 149.4 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 108 | 267.2 cells/mm^3 | Standard Deviation 161.2 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 120 | 269.2 cells/mm^3 | Standard Deviation 169.9 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 132 | 281.3 cells/mm^3 | Standard Deviation 147.3 |
| Nevirapine BID | Change in CD4+ Count From Baseline | Change in CD4+ count to Week 96 | 251.6 cells/mm^3 | Standard Deviation 149.8 |
Secondary
Change in Framingham Score From Baseline
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
Population: FAS with varying numbers missing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | Change in Framingham Score From Baseline | Change in Framingham score to Week 48 | 0.50 Units on a scale | Standard Deviation 2.79 |
| Nevirapine QD | Change in Framingham Score From Baseline | Change in Framingham score to Week 96 | 0.93 Units on a scale | Standard Deviation 3.15 |
| Nevirapine QD | Change in Framingham Score From Baseline | Change in Framingham score to Week 144/EOT | 1.14 Units on a scale | Standard Deviation 3.4 |
| Nevirapine BID | Change in Framingham Score From Baseline | Change in Framingham score to Week 48 | 0.66 Units on a scale | Standard Deviation 2.92 |
| Nevirapine BID | Change in Framingham Score From Baseline | Change in Framingham score to Week 96 | 1.19 Units on a scale | Standard Deviation 3.25 |
| Nevirapine BID | Change in Framingham Score From Baseline | Change in Framingham score to Week 144/EOT | 0.82 Units on a scale | Standard Deviation 3.03 |
Secondary
Change in Mental Health Summary (MHS) Score From Baseline
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
Population: FAS with varying numbers missing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change in Mental Health Summary (MHS) Score From Baseline | Change in MHS score to Week 48 | 4.52 Units on a scale | Standard Deviation 7.84 |
| Nevirapine BID | Change in Mental Health Summary (MHS) Score From Baseline | Change in MHS score to Week 96 | 4.89 Units on a scale | Standard Deviation 9.58 |
| Nevirapine BID | Change in Mental Health Summary (MHS) Score From Baseline | Change in MHS score to Week 144/EOT | 4.70 Units on a scale | Standard Deviation 10.14 |
Secondary
Change in Physical Health Summary (PHS) Score From Baseline
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
Population: FAS with varying numbers missing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change in Physical Health Summary (PHS) Score From Baseline | Change in PHS score to Week 48 | 3.35 Units on a scale | Standard Deviation 8.52 |
| Nevirapine BID | Change in Physical Health Summary (PHS) Score From Baseline | Change in PHS score to Week 96 | 3.00 Units on a scale | Standard Deviation 7.34 |
| Nevirapine BID | Change in Physical Health Summary (PHS) Score From Baseline | Change in PHS score to Week 144/EOT | 3.35 Units on a scale | Standard Deviation 8.42 |
Secondary
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
Calculations based on the MDRD algorithm.
Time frame: From baseline to Week 48, 96, 144
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 48 (N=143, 128, 271, 173) | -5.92 mL/min/1.73 m^2 | Standard Deviation 17.11 |
| Nevirapine BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 144 (N=163, 168, 331, 174) | -6.33 mL/min/1.73 m^2 | Standard Deviation 17.3 |
| Nevirapine BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 96 (N=130, 122, 252, 157) | -10.02 mL/min/1.73 m^2 | Standard Deviation 17.37 |
| Nevirapine QD+BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 96 (N=130, 122, 252, 157) | -8.42 mL/min/1.73 m^2 | Standard Deviation 15.92 |
| Nevirapine QD+BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 48 (N=143, 128, 271, 173) | -4.86 mL/min/1.73 m^2 | Standard Deviation 15.52 |
| Nevirapine QD+BID | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 144 (N=163, 168, 331, 174) | -4.82 mL/min/1.73 m^2 | Standard Deviation 19.06 |
| Atazanvir/Ritonavir | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 48 (N=143, 128, 271, 173) | -7.18 mL/min/1.73 m^2 | Standard Deviation 15.19 |
| Atazanvir/Ritonavir | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 144 (N=163, 168, 331, 174) | -9.56 mL/min/1.73 m^2 | Standard Deviation 17.47 |
| Atazanvir/Ritonavir | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | change baseline to week 96 (N=130, 122, 252, 157) | -11.53 mL/min/1.73 m^2 | Standard Deviation 15.59 |
Secondary
Change of Cholesterol Values From Baseline to Week 48, 96, 144
Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
Time frame: baseline to week 48, 96, 144
Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 96 (N=119,110,145) | 21.66 mg/dL | Standard Deviation 25.14 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 48 (N=138,122,164) | 29.54 mg/dL | Standard Deviation 27.33 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 96 (N=124,114,147) | 36.87 mg/dL | Standard Deviation 30.6 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 144 (N=154,155,160) | 30.66 mg/dL | Standard Deviation 33.24 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 48 (N=136,117,159) | 17.70 mg/dL | Standard Deviation 22.16 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 144 (N=151,150,157) | 17.95 mg/dL | Standard Deviation 26.04 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 48(N=138,122,164) | 11.59 mg/dL | Standard Deviation 10.95 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 96 (N=124,114,147) | 13.33 mg/dL | Standard Deviation 12 |
| Nevirapine BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 144(N=154,155,160) | 10.47 mg/dL | Standard Deviation 15.35 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 144 (N=154,155,160) | 28.13 mg/dL | Standard Deviation 32.06 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 48 (N=138,122,164) | 20.84 mg/dL | Standard Deviation 30.46 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 48(N=138,122,164) | 3.49 mg/dL | Standard Deviation 9.44 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | total cholesterol, week 96 (N=124,114,147) | 29.99 mg/dL | Standard Deviation 31.93 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 144(N=154,155,160) | 5.73 mg/dL | Standard Deviation 11.14 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 96 (N=119,110,145) | 19.19 mg/dL | Standard Deviation 25.49 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 48 (N=136,117,159) | 10.58 mg/dL | Standard Deviation 26.07 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | HDL, week 96 (N=124,114,147) | 4.74 mg/dL | Standard Deviation 10.62 |
| Nevirapine QD+BID | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | LDL-c, week 144 (N=151,150,157) | 17.61 mg/dL | Standard Deviation 28.33 |
Secondary
Change of hsCRP From Baseline to Week 48, 96, 144
Change of hsCRP from baseline to week 48, 96, 144
Time frame: baseline to week 48, 96, 144
Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 96 (N=128,120,157) | -0.79 mg/L | Standard Deviation 21.32 |
| Nevirapine BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 48 (N=142,126,173) | -0.67 mg/L | Standard Deviation 12.71 |
| Nevirapine BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 144 (N=160,164,174) | -0.02 mg/L | Standard Deviation 12.76 |
| Nevirapine QD+BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 48 (N=142,126,173) | -0.70 mg/L | Standard Deviation 8.61 |
| Nevirapine QD+BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 144 (N=160,164,174) | 0.04 mg/L | Standard Deviation 8.2 |
| Nevirapine QD+BID | Change of hsCRP From Baseline to Week 48, 96, 144 | hsCRP, week 96 (N=128,120,157) | 0.35 mg/L | Standard Deviation 15.19 |
Secondary
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
Time frame: baseline to week 48, 96, 144
Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 96 (N=124,114,147) | -0.25 ratio | Standard Deviation 1.03 |
| Nevirapine BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 48 (N=138,122,164) | -0.33 ratio | Standard Deviation 1.05 |
| Nevirapine BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 144 (N=154,155,160) | -0.07 ratio | Standard Deviation 1.45 |
| Nevirapine QD+BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 48 (N=138,122,164) | 0.20 ratio | Standard Deviation 0.99 |
| Nevirapine QD+BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 144 (N=154,155,160) | 0.17 ratio | Standard Deviation 1.05 |
| Nevirapine QD+BID | Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 | total triglycerides, week 96 (N=124,114,147) | 0.28 ratio | Standard Deviation 1.05 |
Secondary
Change of Total Triglycerides From Baseline to Week 48, 96, 144
Change of total triglycerides from baseline to week 48, 96, 144
Time frame: baseline to week 48, 96, 144
Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 96 (N=124,113,147) | 5.35 mg/dL | Standard Deviation 84.92 |
| Nevirapine BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 48 (N=138,120,164) | 1.67 mg/dL | Standard Deviation 99.31 |
| Nevirapine BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 144 (N=153,153,159) | 6.11 mg/dL | Standard Deviation 80.82 |
| Nevirapine QD+BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 48 (N=138,120,164) | 36.28 mg/dL | Standard Deviation 80.24 |
| Nevirapine QD+BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 144 (N=153,153,159) | 27.11 mg/dL | Standard Deviation 85.97 |
| Nevirapine QD+BID | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | total triglycerides, week 96 (N=124,113,147) | 30.45 mg/dL | Standard Deviation 94.99 |
Secondary
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
Changes frombaseline apolipoprotein A1 & B
Time frame: baseline to week 48, 96, 144
Population: FAS, where only patients with corresponding laboratory values for the considered time point are considered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein B, week 144 (N=144,139,148) | 0.05 g/L | Standard Deviation 0.18 |
| Nevirapine BID | 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 0.24 |
| Nevirapine BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein B, week 48 (N=134,120,156) | 0.03 g/L | Standard Deviation 0.16 |
| Nevirapine BID | 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 0.17 |
| Nevirapine BID | 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 0.25 |
| Nevirapine BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein A1, week 144 (N=144,140,148) | 0.14 g/L | Standard Deviation 0.26 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein A1, week 96 (N=115,106,141) | 0.07 g/L | Standard Deviation 0.22 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein A1, week 144 (N=144,140,148) | 0.06 g/L | Standard Deviation 0.23 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein B, week 144 (N=144,139,148) | 0.03 g/L | Standard Deviation 0.17 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein B, week 48 (N=134,120,156) | 0.03 g/L | Standard Deviation 0.16 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein A1, week 48 (N=134,121,156) | 0.08 g/L | Standard Deviation 0.21 |
| Nevirapine QD+BID | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | apolipoprotein B, week 96 (N=115,106,141) | 0.03 g/L | Standard Deviation 0.17 |
Secondary
Genotypic Resistance Associated With Virologic Failure
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
Population: All patients with virologic failure assessed for genotypic resistance
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Genotypic Resistance Associated With Virologic Failure | Emtricitabine-associated substitutions at Week 48 | 21 Number of substitutions |
| Nevirapine QD | Genotypic Resistance Associated With Virologic Failure | Tenofovir-associated substitutions at Week 48 | 11 Number of substitutions |
| Nevirapine QD | Genotypic Resistance Associated With Virologic Failure | Nevirapine-associated substitutions at Week 48 | 34 Number of substitutions |
| Nevirapine BID | Genotypic Resistance Associated With Virologic Failure | Emtricitabine-associated substitutions at Week 48 | 0 Number of substitutions |
| Nevirapine BID | Genotypic Resistance Associated With Virologic Failure | Tenofovir-associated substitutions at Week 48 | 0 Number of substitutions |
| Nevirapine BID | Genotypic Resistance Associated With Virologic Failure | Nevirapine-associated substitutions at Week 48 | 0 Number of substitutions |
Secondary
Glycaemic Abnormalities
Number of patients with AE elevated serum glucose
Time frame: From baseline to Week 144
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Glycaemic Abnormalities | Number with glycaemic abnormalities | 0 Patients |
| Nevirapine QD | Glycaemic Abnormalities | Number without glycaemic abnormalities | 376 Patients |
| Nevirapine BID | Glycaemic Abnormalities | Number with glycaemic abnormalities | 3 Patients |
| Nevirapine BID | Glycaemic Abnormalities | Number without glycaemic abnormalities | 190 Patients |
Secondary
Lipodystrophy
Number of patients with AE lipodystrophy
Time frame: From baseline to Week 144
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Lipodystrophy | Number with lipodystrophy | 1 Patients |
| Nevirapine QD | Lipodystrophy | Number without lipodystrophy | 375 Patients |
| Nevirapine BID | Lipodystrophy | Number with lipodystrophy | 1 Patients |
| Nevirapine BID | Lipodystrophy | Number without lipodystrophy | 192 Patients |
Secondary
Non-scheduled Physician Visits
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
Population: FAS with varying numbers missing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Non-scheduled Physician Visits | Number between baseline and Week 24 | 74 patients |
| Nevirapine QD | Non-scheduled Physician Visits | Number between Week 24 and Week 48 | 45 patients |
| Nevirapine QD | Non-scheduled Physician Visits | Number between Week 48 and Week 96 | 58 patients |
| Nevirapine QD | Non-scheduled Physician Visits | Number between Week 96 and Wk 144/EOT | 58 patients |
| Nevirapine BID | Non-scheduled Physician Visits | Number between Week 96 and Wk 144/EOT | 35 patients |
| Nevirapine BID | Non-scheduled Physician Visits | Number between baseline and Week 24 | 35 patients |
| Nevirapine BID | Non-scheduled Physician Visits | Number between Week 48 and Week 96 | 28 patients |
| Nevirapine BID | Non-scheduled Physician Visits | Number between Week 24 and Week 48 | 35 patients |
Secondary
Number of Patients Hospitalized
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
Population: FAS with varying numbers missing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Number of Patients Hospitalized | Number hospitalized between baseline and Week 24 | 8 Patients |
| Nevirapine QD | Number of Patients Hospitalized | Number hospitalized between Week 24 and Week 48 | 6 Patients |
| Nevirapine QD | Number of Patients Hospitalized | Number hospitalized between Week 48 and Week 96 | 5 Patients |
| Nevirapine QD | Number of Patients Hospitalized | Number hospitalized between Week 96 and Wk 144/EOT | 9 Patients |
| Nevirapine BID | Number of Patients Hospitalized | Number hospitalized between Week 96 and Wk 144/EOT | 1 Patients |
| Nevirapine BID | Number of Patients Hospitalized | Number hospitalized between baseline and Week 24 | 2 Patients |
| Nevirapine BID | Number of Patients Hospitalized | Number hospitalized between Week 48 and Week 96 | 5 Patients |
| Nevirapine BID | Number of Patients Hospitalized | Number hospitalized between Week 24 and Week 48 | 5 Patients |
Secondary
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
Proportion of Patients reporting CNS (central nervous system) side effects of any severity
Time frame: week 148
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine QD | Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity | 41 participants |
| Nevirapine BID | Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity | 41 participants |
| Nevirapine QD+BID | Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity | 37 participants |
Secondary
Proportion of Patients Reporting Hepatic Events of Any Severity
Proportion of Patients reporting hepatic events of any severity
Time frame: week 148
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine QD | Proportion of Patients Reporting Hepatic Events of Any Severity | 26 participants |
| Nevirapine BID | Proportion of Patients Reporting Hepatic Events of Any Severity | 24 participants |
| Nevirapine QD+BID | Proportion of Patients Reporting Hepatic Events of Any Severity | 92 participants |
Secondary
Proportion of Patients Reporting Rash of Any Severity
Proportion of Patients reporting rash of any severity
Time frame: week 148
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine QD | Proportion of Patients Reporting Rash of Any Severity | 75 participants |
| Nevirapine BID | Proportion of Patients Reporting Rash of Any Severity | 64 participants |
| Nevirapine QD+BID | Proportion of Patients Reporting Rash of Any Severity | 74 participants |
Secondary
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Time frame: week 148
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 3 severe | 30 participants |
| Nevirapine QD | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 2 moderate | 74 participants |
| Nevirapine QD | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 4 potential lifethreatening | 9 participants |
| Nevirapine BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 3 severe | 28 participants |
| Nevirapine BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 2 moderate | 84 participants |
| Nevirapine BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 4 potential lifethreatening | 15 participants |
| Nevirapine QD+BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 2 moderate | 72 participants |
| Nevirapine QD+BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 4 potential lifethreatening | 9 participants |
| Nevirapine QD+BID | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | DAIDS 3 severe | 39 participants |
Secondary
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
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
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | 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 |
| Nevirapine BID | 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 | 6 participants |
| Nevirapine BID | 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 | 6 participants |
| Nevirapine BID | 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 |
| Nevirapine QD+BID | 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 | 9 participants |
| Nevirapine QD+BID | 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 | 6 participants |
| Nevirapine QD+BID | 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 | 10 participants |
| Nevirapine QD+BID | 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 | 4 participants |
| Atazanvir/Ritonavir | 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 | 5 participants |
| Atazanvir/Ritonavir | 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 | 2 participants |
| Atazanvir/Ritonavir | 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 |
| Atazanvir/Ritonavir | 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 | 2 participants |
Secondary
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
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
Population: Full Analysis Set (FAS) defined as all randomized and treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine QD | 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 |
| Nevirapine BID | 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 | 5 participants |
| Nevirapine BID | 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 | 6 participants |
| Nevirapine BID | 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 | 9 participants |
| Nevirapine BID | 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 | 2 participants |
| Nevirapine QD+BID | 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 | 10 participants |
| Nevirapine QD+BID | 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 | 9 participants |
| Nevirapine QD+BID | 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 | 17 participants |
| Nevirapine QD+BID | 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 | 5 participants |
| Atazanvir/Ritonavir | 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 | 15 participants |
| Atazanvir/Ritonavir | 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 | 12 participants |
| Atazanvir/Ritonavir | 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 | 5 participants |
| Atazanvir/Ritonavir | 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 | 10 participants |
Secondary
Proportion of Patients With Virologic Failure at Week 48, 96, 144
Time frame: at Week 48, 96, 144
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 48 | 20 participants |
| Nevirapine QD | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 144 | 19 participants |
| Nevirapine QD | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 96 | 15 participants |
| Nevirapine BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 48 | 25 participants |
| Nevirapine BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 144 | 28 participants |
| Nevirapine BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 96 | 25 participants |
| Nevirapine QD+BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 96 | 40 participants |
| Nevirapine QD+BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 48 | 45 participants |
| Nevirapine QD+BID | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 144 | 47 participants |
| Atazanvir/Ritonavir | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 48 | 25 participants |
| Atazanvir/Ritonavir | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 144 | 17 participants |
| Atazanvir/Ritonavir | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | virologic failure at Week 96 | 13 participants |
Comparison: week 48p-value: 0.978495% CI: [-0.065, 0.066]Cochran Chi-Squared
Comparison: week 96p-value: 0.033195% CI: [0.005, 0.123]Cochran Chi-Squared
Comparison: week 144p-value: 0.069195% CI: [-0.005, 0.121]Cochran Chi-Squared
Comparison: week 48p-value: 0.458595% CI: [-0.084, 0.038]Cochran Chi-Squared
Comparison: week 96p-value: 0.543895% CI: [-0.034, 0.064]Cochran Chi-Squared
Comparison: week 144p-value: 0.565995% CI: [-0.039, 0.071]Cochran Chi-Squared
Secondary
Proportion of Patients With VL < 400 Copies/ml
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
Population: FAS with varying numbers missing or not on treatment per visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 4 | 0.365 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 8 | 0.714 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 12 | 0.856 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 24 | 0.924 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 36 | 0.968 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 48 | 0.985 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 60 | 0.993 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 72 | 0.996 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 84 | 0.988 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 96 | 1.000 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 108 | 0.996 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 120 | 1.000 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 132 | 0.996 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 144/EOT | 0.991 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 108 | 1.000 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 4 | 0.287 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 72 | 0.988 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 8 | 0.679 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 132 | 0.993 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 12 | 0.834 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 84 | 0.994 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 24 | 0.956 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 120 | 0.994 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 36 | 0.966 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 96 | 0.987 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 48 | 0.977 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 144/EOT | 0.986 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 400 Copies/ml | Proportion with VL<400 copies /mL at Week 60 | 0.988 Proportion of patients |
Secondary
Proportion of Patients With VL < 50 Copies/ml
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
Population: FAS with varying numbers missing or not on treatment per visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 4 | 0.107 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 8 | 0.304 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 12 | 0.515 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 24 | 0.842 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 36 | 0.907 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 48 | 0.931 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 60 | 0.959 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 72 | 0.965 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 84 | 0.972 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 96 | 0.98 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 108 | 0.964 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 120 | 0.976 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 132 | 0.971 Proportion of patients |
| Nevirapine QD | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 144/EOT | 0.952 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 108 | 0.968 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 4 | 0.09 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 72 | 0.915 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 8 | 0.25 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 132 | 0.947 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 12 | 0.412 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 84 | 0.896 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 24 | 0.779 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 120 | 0.955 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 36 | 0.83 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 96 | 0.924 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 48 | 0.886 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 144/EOT | 0.929 Proportion of patients |
| Nevirapine BID | Proportion of Patients With VL < 50 Copies/ml | Proportion with VL<50 copies /mL at Week 60 | 0.901 Proportion of patients |
Secondary
Serum Lipid Abnormalities
Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
Time frame: From baseline to Week 144
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Serum Lipid Abnormalities | Number with serum lipid abnormalities | 9 patients |
| Nevirapine QD | Serum Lipid Abnormalities | Number without serum lipid abnormalities | 367 patients |
| Nevirapine BID | Serum Lipid Abnormalities | Number with serum lipid abnormalities | 4 patients |
| Nevirapine BID | Serum Lipid Abnormalities | Number without serum lipid abnormalities | 189 patients |
Secondary
Time to Loss of Virologic Response (Rebound)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine QD | Time to Loss of Virologic Response (Rebound) | 143.86 weeks |
| Nevirapine BID | Time to Loss of Virologic Response (Rebound) | 143.21 weeks |
| Nevirapine QD+BID | Time to Loss of Virologic Response (Rebound) | 143.71 weeks |
| Atazanvir/Ritonavir | Time to Loss of Virologic Response (Rebound) | 143.00 weeks |
p-value: 0.132995% CI: [0.535, 1.086]Regression, Cox
Secondary
Time to Treatment Failure
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine QD | Time to Treatment Failure | 143.86 weeks |
| Nevirapine BID | Time to Treatment Failure | 143.21 weeks |
| Nevirapine QD+BID | Time to Treatment Failure | 143.71 weeks |
| Atazanvir/Ritonavir | Time to Treatment Failure | 143.00 weeks |
p-value: 0.044495% CI: [0.539, 0.992]Regression, Cox
Secondary
Time to Treatment Response (First Confirmed VL<50 Copies/mL)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine QD | Time to Treatment Response (First Confirmed VL<50 Copies/mL) | 12.00 weeks |
| Nevirapine BID | Time to Treatment Response (First Confirmed VL<50 Copies/mL) | 12.14 weeks |
| Nevirapine QD+BID | Time to Treatment Response (First Confirmed VL<50 Copies/mL) | 12.00 weeks |
| Atazanvir/Ritonavir | Time to Treatment Response (First Confirmed VL<50 Copies/mL) | 23.71 weeks |
p-value: 0.000295% CI: [0.57, 0.839]Regression, Cox
Comparison: Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)p-value: <0.000195% CI: [0.519, 0.764]Regression, Cox
Secondary
Treatment-emergent AIDS-defining Illness
Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
Time frame: From baseline to Week 144
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment-emergent AIDS-defining Illness | Number with tr.-emerg. AIDS-def.illness | 26 Patients |
| Nevirapine QD | Treatment-emergent AIDS-defining Illness | Number without tr.-emerg. AIDS-def.illness | 350 Patients |
| Nevirapine BID | Treatment-emergent AIDS-defining Illness | Number with tr.-emerg. AIDS-def.illness | 7 Patients |
| Nevirapine BID | Treatment-emergent AIDS-defining Illness | Number without tr.-emerg. AIDS-def.illness | 186 Patients |
Secondary
Treatment-emergent AIDS-defining Illness Leading to Death
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
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment-emergent AIDS-defining Illness Leading to Death | Number with AIDS-def. illness leading to death | 3 Patients |
| Nevirapine QD | Treatment-emergent AIDS-defining Illness Leading to Death | Number without AIDS-def. illness leading to death | 373 Patients |
| Nevirapine BID | Treatment-emergent AIDS-defining Illness Leading to Death | Number with AIDS-def. illness leading to death | 0 Patients |
| Nevirapine BID | Treatment-emergent AIDS-defining Illness Leading to Death | Number without AIDS-def. illness leading to death | 193 Patients |
p-value: 0.040395% CI: [0.22, 0.966]Regression, Cox
Secondary
Treatment Response at Week 144
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment Response at Week 144 | Number of responders | 121 participants |
| Nevirapine QD | Treatment Response at Week 144 | Number of non-responders | 67 participants |
| Nevirapine BID | Treatment Response at Week 144 | Number of non-responders | 75 participants |
| Nevirapine BID | Treatment Response at Week 144 | Number of responders | 113 participants |
| Nevirapine QD+BID | Treatment Response at Week 144 | Number of responders | 234 participants |
| Nevirapine QD+BID | Treatment Response at Week 144 | Number of non-responders | 142 participants |
| Atazanvir/Ritonavir | Treatment Response at Week 144 | Number of responders | 143 participants |
| Atazanvir/Ritonavir | Treatment Response at Week 144 | Number of non-responders | 50 participants |
p-value: 0.003195% CI: [-0.194, -0.04]Cochran-Mantel-Haenszel
p-value: 0.036595% CI: [-0.186, -0.006]Cochran-Mantel-Haenszel
p-value: 0.003395% CI: [-0.231, -0.046]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 48 (TLOVR Algorithm)
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
Population: FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment Response at Week 48 (TLOVR Algorithm) | Number of responders | 261 Patients |
| Nevirapine QD | Treatment Response at Week 48 (TLOVR Algorithm) | Number of non-responders | 115 Patients |
| Nevirapine BID | Treatment Response at Week 48 (TLOVR Algorithm) | Number of responders | 142 Patients |
| Nevirapine BID | Treatment Response at Week 48 (TLOVR Algorithm) | Number of non-responders | 51 Patients |
p-value: 0.32195% CI: [-0.112, 0.037]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 96
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine QD | Treatment Response at Week 96 | Number of responders | 131 participants |
| Nevirapine QD | Treatment Response at Week 96 | Number of non-responders | 57 participants |
| Nevirapine BID | Treatment Response at Week 96 | Number of non-responders | 66 participants |
| Nevirapine BID | Treatment Response at Week 96 | Number of responders | 122 participants |
| Nevirapine QD+BID | Treatment Response at Week 96 | Number of responders | 253 participants |
| Nevirapine QD+BID | Treatment Response at Week 96 | Number of non-responders | 123 participants |
| Atazanvir/Ritonavir | Treatment Response at Week 96 | Number of responders | 149 participants |
| Atazanvir/Ritonavir | Treatment Response at Week 96 | Number of non-responders | 44 participants |
p-value: 0.007395% CI: [-0.212, -0.033]Cochran-Mantel-Haenszel
p-value: 0.010995% CI: [-0.171, -0.022]Cochran-Mantel-Haenszel
p-value: 0.103395% CI: [-0.158, 0.015]Cochran-Mantel-Haenszel