Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
- Conditions
- HIV Infections
- Registration Number
- NCT00979420
- 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). An observation period of about 10 years extends far beyond the duration of clinical trials. 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 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
Study Design:
observational
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. Change in log10 Viral Load From Baseline to Last Visit Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
- Secondary Outcome Measures
Name Time Method Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Duration of Intake of Viramune End of treatment, up to 185 months Duration of intake of Viramune
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
History of Therapy With Antiretroviral Medication Baseline Participants with a history of therapy with antiretroviral medication.
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade Up to 185 months Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Number of Participants With Drug Related Adverse Events Up to 185 months Number of participants with drug related Adverse Events (AEs)
Course of Absolute CD4+ Cell Count Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Trial Locations
- Locations (60)
Boehringer Ingelheim Investigational Site 28
🇩🇪Freiburg, Germany
Boehringer Ingelheim Investigational Site 36
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 37
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 40
🇩🇪Heidelberg, Germany
Boehringer Ingelheim Investigational Site 11
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 1
🇩🇪Aachen, Germany
Boehringer Ingelheim Investigational Site 13
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 10
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 12
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 15
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 2
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 14
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 4
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 3
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 5
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 6
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 8
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 7
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 9
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 16
🇩🇪Bochum, Germany
Boehringer Ingelheim Investigational Site 17
🇩🇪Bonn, Germany
Boehringer Ingelheim Investigational Site 18
🇩🇪Bremen, Germany
Boehringer Ingelheim Investigational Site 20
🇩🇪Duisburg, Germany
Boehringer Ingelheim Investigational Site 19
🇩🇪Dortmund, Germany
Boehringer Ingelheim Investigational Site 21
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 23
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 22
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 24
🇩🇪Düsseldorf, Germany
Boehringer Ingelheim Investigational Site 25
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 26
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 27
🇩🇪Frankfurt, Germany
Boehringer Ingelheim Investigational Site 30
🇩🇪Freiburg, Germany
Boehringer Ingelheim Investigational Site 32
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 31
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 29
🇩🇪Freiburg, Germany
Boehringer Ingelheim Investigational Site 33
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 35
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 34
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 38
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 39
🇩🇪Hannover, Germany
Boehringer Ingelheim Investigational Site 41
🇩🇪Karlsruhe, Germany
Boehringer Ingelheim Investigational Site 42
🇩🇪Koblenz, Germany
Boehringer Ingelheim Investigational Site 43
🇩🇪Leipzig, Germany
Boehringer Ingelheim Investigational Site 46
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 44
🇩🇪Mannheim, Germany
Boehringer Ingelheim Investigational Site 45
🇩🇪Mannheim, Germany
Boehringer Ingelheim Investigational Site 49
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 50
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 53
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 48
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 47
🇩🇪München, Germany
Boehringer Ingelheim Investigational Site 52
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 51
🇩🇪Münster, Germany
Boehringer Ingelheim Investigational Site 54
🇩🇪Oldenburg, Germany
Boehringer Ingelheim Investigational Site 55
🇩🇪Osnabrück, Germany
Boehringer Ingelheim Investigational Site 56
🇩🇪Saarbrücken, Germany
Boehringer Ingelheim Investigational Site 57
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 59
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 58
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 60
🇩🇪Wuppertal, Germany