Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
- Conditions
- HIV Infections
- Registration Number
- NCT01134939
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Time Perspective:
retro- and prospective
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients With Virologic Response (VR) After 36 Months 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.
- Secondary Outcome Measures
Name Time Method Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data ( ALT) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Viral Load After 36 Months From Baseline Baseline and 36 months 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.
Changes in the CD4+ Cell Count After 36 Months From Baseline Baseline and 36 months 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.
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (AST) After 36 Months From Baseline Baseline and 36 months 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. .
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline Baseline and 36 months 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. .
Trial Locations
- Locations (34)
Boehringer Ingelheim Investigational Site 21
🇩🇪Leipzig, Germany
Boehringer Ingelheim Investigational Site 10
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 11
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 23
🇩🇪Aachen, 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 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, 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
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 16
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 32
🇩🇪Karlsruhe, Germany
Boehringer Ingelheim Investigational Site 15
🇩🇪Koblenz, Germany
Boehringer Ingelheim Investigational Site 25
🇩🇪Köln, Germany
Boehringer Ingelheim Investigational Site 20
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 24
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 7
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 3
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 13
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 18
🇩🇪Osnabrück, Germany
Boehringer Ingelheim Investigational Site 30
🇩🇪Stuttgart, Germany