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The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.
Time Perspective:
retro- and prospective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected women and men |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Virologic Response (VR) After 36 Months | VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Viral Load After 36 Months From Baseline | The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load. | Baseline and 36 months |
| Changes in the CD4+ Cell Count After 36 Months From Baseline |
Not provided
Inclusion criteria:
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC
Exclusion criteria:
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/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 23 | Aachen | Germany | ||||
| Boehringer Ingelheim Investigational Site 10 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-naive Female Patients | Female patients who were not pretreated with HIV therapy. |
| FG001 | Treatment-naive Male Patients | Male patients who were not pretreated with HIV therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count. |
| Baseline and 36 months |
| Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data ( ALT) After 36 Months From Baseline | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (AST) After 36 Months From Baseline | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Baseline and 36 months |
| Berlin |
| Germany |
| Boehringer Ingelheim Investigational Site 11 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 14 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 19 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 26 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 28 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 33 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 4 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 5 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 8 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 9 | Berlin | Germany |
| Boehringer Ingelheim Investigational Site 31 | Chemnitz | Germany |
| Boehringer Ingelheim Investigational Site 25 | Cologne | Germany |
| Boehringer Ingelheim Investigational Site 29 | Dortmund | Germany |
| Boehringer Ingelheim Investigational Site 27 | Düsseldorf | Germany |
| Boehringer Ingelheim Investigational Site 17 | Frankfurt | Germany |
| Boehringer Ingelheim Investigational Site 1 | Frankfurt | Germany |
| Boehringer Ingelheim Investigational Site 2 | Freiburg im Breisgau | Germany |
| Boehringer Ingelheim Investigational Site 34 | Giessen | Germany |
| Boehringer Ingelheim Investigational Site 22 | Hamburg | Germany |
| Boehringer Ingelheim Investigational Site 6 | Hamburg | Germany |
| Boehringer Ingelheim Investigational Site 12 | Hanover | Germany |
| Boehringer Ingelheim Investigational Site 16 | Hanover | Germany |
| Boehringer Ingelheim Investigational Site 32 | Karlsruhe | Germany |
| Boehringer Ingelheim Investigational Site 15 | Koblenz | Germany |
| Boehringer Ingelheim Investigational Site 21 | Leipzig | Germany |
| Boehringer Ingelheim Investigational Site 20 | München | Germany |
| Boehringer Ingelheim Investigational Site 24 | München | Germany |
| Boehringer Ingelheim Investigational Site 3 | München | Germany |
| Boehringer Ingelheim Investigational Site 7 | München | Germany |
| Boehringer Ingelheim Investigational Site 13 | Münster | Germany |
| Boehringer Ingelheim Investigational Site 18 | Osnabrück | Germany |
| Boehringer Ingelheim Investigational Site 30 | Stuttgart | Germany |
| FG002 | Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL | Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| FG003 | Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL | Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| FG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| FG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| FG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| FG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS): This patient set includes all HIV-1 infected patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment and of an antiretroviral combination partner.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-naive Female Patients | Female patients who were not pretreated with HIV therapy. |
| BG001 | Treatment-naive Male Patients | Male patients who were not pretreated with HIV therapy. |
| BG002 | Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL | Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| BG003 | Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL | Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| BG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| BG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| BG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| BG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| BG008 | 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 |
|
| 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 | Number of Patients With Virologic Response (VR) After 36 Months | VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. | Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint. | Posted | Number | participants | 36 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Viral Load After 36 Months From Baseline | The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load. | Patients from FAS with values for viral load at baseline and after 36 months. | Posted | Mean | Standard Deviation | Log10 copies/mL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the CD4+ Cell Count After 36 Months From Baseline | The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count. | Patients from FAS with values for CD4+ at baseline and after 36 months. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for total cholesterol at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for HDL cholesterol at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for LDL cholesterol at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for triglycerides at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for blood glucose at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data ( ALT) After 36 Months From Baseline | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for ALT at baseline and at month 36. | Posted | Mean | Standard Deviation | U/L | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (AST) After 36 Months From Baseline | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for the AST at baseline and at month 36. | Posted | Mean | Standard Deviation | U/L | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for Gamma GT at baseline and at month 36. | Posted | Mean | Standard Deviation | U/L | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for creatinine at baseline and at month 36. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. . | Patients from TS with evaluable data for haemoglobin at baseline and at month 36. | Posted | Mean | Standard Deviation | g/dL | Baseline and 36 months |
|
36 months
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 | Treatment-naive Patients | Female and male patients who were not pretreated with HIV therapy. | 7 | 101 | 46 | 101 | ||
| EG001 | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. | 10 | 97 | 56 | 97 | ||
| EG002 | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. | 4 | 47 | 24 | 47 | ||
| EG003 | Patients With Baseline Viral Load Not Documented | Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value. | 1 | 20 | 8 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Swelling | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster infection neurological | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MEDDRA 17.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MEDDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MEDDRA 17.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 17.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MEDDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
|
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| 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
| Male |
|
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. |
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
| OG004 | Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL | Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG005 | Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL | Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. |
| OG006 | Female Patients, Baseline Viral Load Not Documented | Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
| OG007 | Male Patients, Baseline Viral Load Not Documented | Male patients who could not be assigned to one of the three subgroups and had no documented viral load value. |
|
|