Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00876733
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs 36 months Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
- Secondary Outcome Measures
Name Time Method 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 (Total Cholesterol) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 12 Months From Baseline Baseline and 12 months The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 Laboratory Data (AST) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 (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 Viral Load After 12 Months From Baseline. Baseline and 12 months The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. Baseline and 12 months The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Changes in the CD4+ Cell Count After 36 Months From Baseline. Baseline and 36 months The change in the 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 (Triglycerides) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Changes in the Laboratory Data (ALT) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline Baseline and 12 months The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 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 (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.
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 (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 (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 (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.
Trial Locations
- Locations (66)
Boehringer Ingelheim Investigational Site 15
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 12
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 14
🇩🇪Aachen, Germany
Boehringer Ingelheim Investigational Site 13
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 19
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 21
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 23
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 24
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 28
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 30
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 31
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 41
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 34
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 38
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 60
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 54
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 63
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 8
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 58
🇩🇪Bochum, Germany
Boehringer Ingelheim Investigational Site 50
🇩🇪Chemnitz, Germany
Boehringer Ingelheim Investigational Site 48
🇩🇪Dortmund, Germany
Boehringer Ingelheim Investigational Site 27
🇩🇪Duisburg, Germany
Boehringer Ingelheim Investigational Site 49
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 62
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 9
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 32
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 59
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 65
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 57
🇩🇪Freiburg, Germany
Boehringer Ingelheim Investigational Site 56
🇩🇪Fürth, Germany
Boehringer Ingelheim Investigational Site 29
🇩🇪Gießen, Germany
Boehringer Ingelheim Investigational Site 33
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 42
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 51
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 47
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 40
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 43
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 25
🇩🇪Koblenz, Germany
Boehringer Ingelheim Investigational Site 46
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 37
🇩🇪Krefeld, Germany
Boehringer Ingelheim Investigational Site 6
🇩🇪Karlsruhe, Germany
Boehringer Ingelheim Investigational Site 61
🇩🇪Köln, Germany
Boehringer Ingelheim Investigational Site 53
🇩🇪Köln, Germany
Boehringer Ingelheim Investigational Site 11
🇩🇪Leipzig, Germany
Boehringer Ingelheim Investigational Site 52
🇩🇪Mainz, Germany
Boehringer Ingelheim Investigational Site 18
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 20
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 26
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 22
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 5
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 35
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 16
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 17
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 10
🇩🇪Neuss, Germany
Boehringer Ingelheim Investigational Site 55
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 39
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 36
🇩🇪Oldenburg, Germany
Boehringer Ingelheim Investigational Site 64
🇩🇪Osnabrück, Germany
Boehringer Ingelheim Investigational Site 7
🇩🇪Pforzheim, Germany
Boehringer Ingelheim Investigational Site 66
🇩🇪Potsdam, Germany
Boehringer Ingelheim Investigational Site 1
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 3
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 4
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 2
🇩🇪Wiesbaden, Germany
Boehringer Ingelheim Investigational Site 45
🇩🇪Troisdorf, Germany
Boehringer Ingelheim Investigational Site 44
🇩🇪Wuppertal, Germany