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The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients HIV-1 positive |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Reporting Adverse Events | the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response (VR) | VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine. |
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Inclusion criteria:
The inclusion criteria follow the same criteria which are describe in the newest SPC.
Exclusion criteria:
The exclusion criteria follow the same criteria which are describe in the newest SPC.
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patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Graz | Austria | ||||
| Boehringer Ingelheim Investigational Site 2 |
This was an observational, non-interventional, uncontrolled, prospective post marketing study.
There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nevirapine | Patients treated with 200 mg Nevirapine twice daily (administered orally). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 48 weeks |
| Change in CD4+ Cell Count From Baseline to Week 48 | Calculated as CD4+ cell count at week 48 minus the baseline value | Baseline and week 48 |
| Linz |
| Austria |
| Boehringer Ingelheim Investigational Site 3 | Salzburg | Austria |
| Boehringer Ingelheim Investigational Site 4 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 5 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 6 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 7 | Wels | Austria |
| Boehringer Ingelheim Investigational Site 8 | Bialystok | Poland |
| Boehringer Ingelheim Investigational Site 9 | Bydgoszcz | Poland |
| Boehringer Ingelheim Investigational Site 10 | Chorzów | Poland |
| Boehringer Ingelheim Investigational Site 11 | Gdansk | Poland |
| Boehringer Ingelheim Investigational Site 12 | Krakow | Poland |
| Boehringer Ingelheim Investigational Site 13 | Lódz | Poland |
| Boehringer Ingelheim Investigational Site 14 | Poznan | Poland |
| Boehringer Ingelheim Investigational Site 15 | Szczecin | Poland |
| Boehringer Ingelheim Investigational Site 16 | Warsaw | Poland |
| Boehringer Ingelheim Investigational Site 17 | Wroclaw | Poland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set
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| ID | Title | Description |
|---|---|---|
| BG000 | Nevirapine | Patients treated with 200 mg Nevirapine twice daily (administered orally). |
| 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 |
|
| 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 | Proportion of Patients Reporting Adverse Events | the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term. | The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine. | Posted | Number | Percentage of participants | 48 weeks |
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| Secondary | Virologic Response (VR) | VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine. | TS | Posted | Number | Participants | 48 weeks |
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| Secondary | Change in CD4+ Cell Count From Baseline to Week 48 | Calculated as CD4+ cell count at week 48 minus the baseline value | TS with non-missing data at baseline and week 48 | Posted | Mean | Standard Deviation | Cells/mm^3 | Baseline and week 48 |
|
|
48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nevirapine | Patients treated with 200 mg Nevirapine twice daily (administered orally). | 12 | 278 | 0 | 278 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Lymphadenopathy, generalised | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Cholecystitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Melena | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pregnancy | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Clostridia enteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Helicobacter phylori infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| porta catheter infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Staphylococcus sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Fracture of foot | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Hyperkaliemia | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Lymphoma of the brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Diabetes insipitus | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Pneumocystitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Enanthema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Herpes eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Fever | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Shunt thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
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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 |
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| Title | Measurements |
|---|---|
|
| rash, any severity |
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| hepatic events, any severity |
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| Central Nervous system side effects, any severity |
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| Title | Denominators | Categories |
|---|
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