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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004330-40 | EudraCT Number | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP bid | Active Comparator | nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF) |
|
| NVP qd | Experimental | nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF) |
|
| ATZ/r | Active Comparator | ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nevirapine bid | Drug | nevirapine twice daily |
| |
| nevirapine qd |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Week 48 |
Not provided
Inclusion criteria:
Inclusion Criteria:
Exclusion criteria:
Exclusion Criteria:
Active drug abuse or chronic alcoholism at the investigator's discretion
Hepatic cirrhosis stage Child-Pugh B or C
Female patients of child-bearing potential who:
Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)
Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
Hypersensitivity to any ingredients of the test products
Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study
Patients who are receiving other concomitant treatments which are not permitted
Use of other investigational medications within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
Patients who are receiving systemic treatment for malignant disease
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1100.1470.54004 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||||
| 1100.1470.54002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21628668 | Derived | Seclen E, Soriano V, Gonzalez MM, Martin-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218. | |
| 21555816 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nevirapine QD | Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD) |
| FG001 | Nevirapine BID | NVP 200mg BID on a background of the fixed combination Truvada® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
nevirapine once daily |
|
| atazanavir | Drug | atazanavir once daily |
|
| 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 | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
| 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) | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
| 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 | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
| 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. | From baseline to Weeks 48, 96 and 144/EOT |
| 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. | From baseline to Weeks 48, 96 and 144/EOT |
| 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. | From baseline to Weeks 48, 96 and 144/EOT |
| Number of Patients Hospitalized | Cost effectiveness assessment by number of patients hospitalized | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT |
| Non-scheduled Physician Visits | Cost effectiveness assessment by number of patients with non-scheduled physician visits | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT |
| 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. | From baseline to Week 48 |
| Treatment-emergent AIDS-defining Illness | Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment | From baseline to Week 144 |
| 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. | From baseline to Week 144 |
| Lipodystrophy | Number of patients with AE lipodystrophy | From baseline to Week 144 |
| Serum Lipid Abnormalities | Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia) | From baseline to Week 144 |
| Glycaemic Abnormalities | Number of patients with AE elevated serum glucose | From baseline to Week 144 |
| 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. | From baseline to Week 96 |
| 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. | From baseline to Week 144 |
| 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) | at Week 24, 48, 96, 144 |
| 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) | at Week 24, 48, 96, 144 |
| 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) | Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response | baseline to week 144 |
| 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. | Baseline to week 144 |
| 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 | baseline to week 144 |
| Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | Calculations based on the MDRD algorithm. | From baseline to Week 48, 96, 144 |
| Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | week 148 |
| Proportion of Patients Reporting Rash of Any Severity | Proportion of Patients reporting rash of any severity | week 148 |
| Proportion of Patients Reporting Hepatic Events of Any Severity | Proportion of Patients reporting hepatic events of any severity | week 148 |
| 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 | week 148 |
| Change of Cholesterol Values From Baseline to Week 48, 96, 144 | Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL | baseline to week 48, 96, 144 |
| Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | Changes frombaseline apolipoprotein A1 & B | baseline to week 48, 96, 144 |
| Change of hsCRP From Baseline to Week 48, 96, 144 | Change of hsCRP 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 triglycerides 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 | Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144 | baseline to week 48, 96, 144 |
| Córdoba |
| Argentina |
| 1100.1470.54003 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina |
| 1100.1470.54001 Boehringer Ingelheim Investigational Site | Rosario | Argentina |
| 1100.1470.49001 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1100.1470.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1100.1470.49003 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 1100.1470.49018 Boehringer Ingelheim Investigational Site | Bonn | Germany |
| 1100.1470.49014 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1100.1470.49008 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1100.1470.49035 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1100.1470.49036 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 1100.1470.49033 Boehringer Ingelheim Investigational Site | Freiburg/Breisgau | Germany |
| 1100.1470.49016 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1100.1470.49031 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1100.1470.49037 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1100.1470.49020 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1100.1470.49038 Boehringer Ingelheim Investigational Site | Magdeburg | Germany |
| 1100.1470.49034 Boehringer Ingelheim Investigational Site | München | Germany |
| 1100.1470.49000 Boehringer Ingelheim Investigational Site | Ulm | Germany |
| 1100.1470.49032 Boehringer Ingelheim Investigational Site | Würzburg | Germany |
| 1100.1470.39001 Boehringer Ingelheim Investigational Site | Bergamo | Italy |
| 1100.1470.39003 Boehringer Ingelheim Investigational Site | Bologna | Italy |
| 1100.1470.39012 Ospedale Sant'Anna | Como | Italy |
| 1100.1470.39006 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1100.1470.39010 Boehringer Ingelheim Investigational Site | Lecco | Italy |
| 1100.1470.39004 Boehringer Ingelheim Investigational Site | Torino | Italy |
| 1100.1470.39009 Boehringer Ingelheim Investigational Site | Torrette Di Ancona | Italy |
| 1100.1470.39007 Boehringer Ingelheim Investigational Site | Varese | Italy |
| 1100.1470.55006 Boehringer Ingelheim Investigational Site | Aguascalientes | Mexico |
| 1100.1470.55004 Boehringer Ingelheim Investigational Site | Col Obregón | Mexico |
| 1100.1470.55008 Boehringer Ingelheim Investigational Site | Col. Los Filtros, San Luis Potosí | Mexico |
| 1100.1470.55001 Boehringer Ingelheim Investigational Site | Col. Toriello Guerra | Mexico |
| 1100.1470.55007 Boehringer Ingelheim Investigational Site | Guadalajara Jal. | Mexico |
| 1100.1470.55003 Boehringer Ingelheim Investigational Site | Tlalpan-México D,F | Mexico |
| 1100.1470.48003 Boehringer Ingelheim Investigational Site | Bydgoszcz | Poland |
| 1100.1470.48001 Boehringer Ingelheim Investigational Site | Chorzów | Poland |
| 1100.1470.48002 Boehringer Ingelheim Investigational Site | Szczecin | Poland |
| 1100.1470.48004 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1100.1470.35102 Boehringer Ingelheim Investigational Site | Cascais | Portugal |
| 1100.1470.35101 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1100.1470.35103 Boehringer Ingelheim Investigational Site | Porto | Portugal |
| 1100.1470.40001 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1100.1470.40002 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1100.1470.34013 Boehringer Ingelheim Investigational Site | Alcalá de Henares (Madrid) | Spain |
| 1100.1470.34008 Boehringer Ingelheim Investigational Site | Badalona | Spain |
| 1100.1470.34002 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1100.1470.34003 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1100.1470.34004 Boehringer Ingelheim Investigational Site | Donostia / San Sebastian | Spain |
| 1100.1470.34009 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| 1100.1470.34010 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1100.1470.34012 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1100.1470.34014 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1100.1470.34015 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1100.1470.34019 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1100.1470.34007 Boehringer Ingelheim Investigational Site | Sabadell (Barcelona) | Spain |
| 1100.1470.34006 Boehringer Ingelheim Investigational Site | Santa Cruz de Tenerife | Spain |
| 1100.1470.34011 Boehringer Ingelheim Investigational Site | Vigo | Spain |
| 1100.1470.41004 Boehringer Ingelheim Investigational Site | Bern | Switzerland |
| 1100.1470.41001 Boehringer Ingelheim Investigational Site | Lugano | Switzerland |
| 1100.1470.41003 Boehringer Ingelheim Investigational Site | Sankt Gallen | Switzerland |
| 1100.1470.41002 Boehringer Ingelheim Investigational Site | Zurich | Switzerland |
| 1100.1470.44004 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom |
| 1100.1470.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1100.1470.44002 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1100.1470.44005 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1100.1470.44006 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1100.1470.44003 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
| Soriano V, Arasteh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745. |
| FG002 | Atazanvir/Ritonavir | Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada® |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nevirapine QD | Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD) |
| BG001 | Nevirapine BID | NVP 200mg BID on a background of the fixed combination Truvada® |
| BG002 | Atazanvir/Ritonavir | ATZ/r on a background of the fixed combination Truvada® |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline HIV viral load category | Number | participants |
| ||||||||||||||||
| Baseline log10 HIV viral load | 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data | Mean | Standard Deviation | log 10 Copies/mL |
| ||||||||||||||
| Baseline CD4+ cell count | 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data | Mean | Standard Deviation | Cells/mm^3 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | Patients | From baseline to Week 48 |
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| 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. | FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories | Posted | Number | Patients | From baseline to Week 48 |
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| 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 | FAS with varying numbers missing or not on treatment per visit | Posted | Number | Proportion of patients | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
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| 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) | FAS with varying numbers missing or not on treatment per visit | Posted | Number | Proportion of patients | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
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| 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 | FAS with varying numbers missing or not on treatment per visit | Posted | Mean | Standard Deviation | cells/mm^3 | From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT |
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| 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. | FAS with varying numbers missing | Posted | Mean | Standard Deviation | Units on a scale | From baseline to Weeks 48, 96 and 144/EOT |
|
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| 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. | FAS with varying numbers missing | Posted | Mean | Standard Deviation | Units on a scale | From baseline to Weeks 48, 96 and 144/EOT |
|
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| 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. | FAS with varying numbers missing | Posted | Mean | Standard Deviation | Units on a scale | From baseline to Weeks 48, 96 and 144/EOT |
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| Secondary | Number of Patients Hospitalized | Cost effectiveness assessment by number of patients hospitalized | FAS with varying numbers missing | Posted | Number | Patients | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT |
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| Secondary | Non-scheduled Physician Visits | Cost effectiveness assessment by number of patients with non-scheduled physician visits | FAS with varying numbers missing | Posted | Number | patients | From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT |
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| 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. | All patients with virologic failure assessed for genotypic resistance | Posted | Number | Number of substitutions | From baseline to Week 48 |
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| Secondary | Treatment-emergent AIDS-defining Illness | Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment | FAS | Posted | Number | Patients | From baseline to Week 144 |
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| 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. | FAS | Posted | Number | Patients | From baseline to Week 144 |
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| Secondary | Lipodystrophy | Number of patients with AE lipodystrophy | FAS | Posted | Number | Patients | From baseline to Week 144 |
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| Secondary | Serum Lipid Abnormalities | Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia) | FAS | Posted | Number | patients | From baseline to Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycaemic Abnormalities | Number of patients with AE elevated serum glucose | FAS | Posted | Number | Patients | From baseline to Week 144 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Number | participants | From baseline to Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | From baseline to Week 144 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | at Week 24, 48, 96, 144 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | at Week 24, 48, 96, 144 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Virologic Failure at Week 48, 96, 144 | 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 | Posted | Number | participants | at Week 48, 96, 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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 | Posted | Median | Inter-Quartile Range | weeks | baseline to week 144 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Median | Inter-Quartile Range | weeks | Baseline to week 144 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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 | Posted | Median | Inter-Quartile Range | weeks | baseline to week 144 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 | Calculations based on the MDRD algorithm. | 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 | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | From baseline to Week 48, 96, 144 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | week 148 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Reporting Rash of Any Severity | Proportion of Patients reporting rash of any severity | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | week 148 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Reporting Hepatic Events of Any Severity | Proportion of Patients reporting hepatic events of any severity | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | week 148 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Full Analysis Set (FAS) defined as all randomized and treated patients. | Posted | Number | participants | week 148 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Cholesterol Values From Baseline to Week 48, 96, 144 | Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL | FAS, where only patients with corresponding laboratory values for the considered time point are considered | Posted | Mean | Standard Deviation | mg/dL | baseline to week 48, 96, 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 | Changes frombaseline apolipoprotein A1 & B | FAS, where only patients with corresponding laboratory values for the considered time point are considered | Posted | Mean | Standard Deviation | g/L | baseline to week 48, 96, 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of hsCRP From Baseline to Week 48, 96, 144 | Change of hsCRP from baseline to week 48, 96, 144 | FAS, where only patients with corresponding laboratory values for the considered time point are considered | Posted | Mean | Standard Deviation | mg/L | baseline to week 48, 96, 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Total Triglycerides From Baseline to Week 48, 96, 144 | Change of total triglycerides from baseline to week 48, 96, 144 | FAS, where only patients with corresponding laboratory values for the considered time point are considered | Posted | Mean | Standard Deviation | mg/dL | baseline to week 48, 96, 144 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | FAS, where only patients with corresponding laboratory values for the considered time point are considered | Posted | Mean | Standard Deviation | ratio | baseline to week 48, 96, 144 |
|
|
148 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nevirapine QD | NVP 400mg QD on a background of the fixed combination Truvada® | 25 | 188 | 136 | 188 | ||
| EG001 | Nevirapine BID | NVP 200mg BID on a background of the fixed combination Truvada® | 31 | 188 | 141 | 188 | ||
| EG002 | Atazanvir/Ritonavir | ATZ/r on a background of the fixed combination Truvada® | 27 | 193 | 161 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Puncture site haemorrhage | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Neurosyphilis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Papilloma viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Fracture of penis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebellar syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Breast prosthesis implantation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Mastoidectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Tympanoplasty | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular icterus | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Baseline HIV viral load > 100,000 copies/mL |
|
| Number of non-responders |
|
| Cochran-Mantel-Haenszel |
Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients. |
| 0.584 |
Test for superiority following confirmation of non-inferiority |
| Risk Difference (RD) |
| 0.025 |
| 95 |
| -0.065 |
| 0.115 |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority margin 12% (or 0.12 as proportion) |
| Cochran-Mantel-Haenszel | Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients. | 0.855 | Test for superiority following confirmation of non-inferiority | Risk Difference (RD) | 0.009 | 95 | -0.084 | 0.101 | Yes | Non-Inferiority or Equivalence | Non-inferiority margin 12% (or 0.12 as proportion) |
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