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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | 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 |
- Change in log10 Viral Load From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]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.
- Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]
- Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]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.
- Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 Triglycerides During Study (Worst Grade) by DAIDS Grade [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]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.
| Study Start Date: | August 2009 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| HIV treatment |
Detailed Description:
Study Design:
observational
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients
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 (R08-0843)
Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).
Contacts and Locations
Hide Study Locations| Germany | |
| Boehringer Ingelheim Investigational Site 1 | |
| Aachen, Germany | |
| Boehringer Ingelheim Investigational Site 2 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 3 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 4 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 5 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 6 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 7 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 8 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 9 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 10 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 11 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 12 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 13 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 14 | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site 15 | |
| 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 19 | |
| Dortmund, Germany | |
| Boehringer Ingelheim Investigational Site 20 | |
| Duisburg, Germany | |
| Boehringer Ingelheim Investigational Site 21 | |
| Düsseldorf, Germany | |
| Boehringer Ingelheim Investigational Site 22 | |
| Düsseldorf, Germany | |
| Boehringer Ingelheim Investigational Site 23 | |
| 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 28 | |
| Freiburg, Germany | |
| Boehringer Ingelheim Investigational Site 29 | |
| Freiburg, Germany | |
| Boehringer Ingelheim Investigational Site 30 | |
| Freiburg, Germany | |
| Boehringer Ingelheim Investigational Site 31 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 32 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 33 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 34 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 35 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 36 | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site 37 | |
| Hannover, Germany | |
| Boehringer Ingelheim Investigational Site 38 | |
| Hannover, Germany | |
| Boehringer Ingelheim Investigational Site 39 | |
| Hannover, Germany | |
| Boehringer Ingelheim Investigational Site 40 | |
| Heidelberg, 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 44 | |
| Mannheim, Germany | |
| Boehringer Ingelheim Investigational Site 45 | |
| Mannheim, Germany | |
| Boehringer Ingelheim Investigational Site 46 | |
| München, Germany | |
| Boehringer Ingelheim Investigational Site 47 | |
| München, Germany | |
| Boehringer Ingelheim Investigational Site 48 | |
| München, Germany | |
| Boehringer Ingelheim Investigational Site 49 | |
| München, Germany | |
| Boehringer Ingelheim Investigational Site 50 | |
| München, Germany | |
| Boehringer Ingelheim Investigational Site 51 | |
| Münster, Germany | |
| Boehringer Ingelheim Investigational Site 52 | |
| Münster, Germany | |
| Boehringer Ingelheim Investigational Site 53 | |
| 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 58 | |
| Stuttgart, Germany | |
| Boehringer Ingelheim Investigational Site 59 | |
| Stuttgart, Germany | |
| Boehringer Ingelheim Investigational Site 60 | |
| Wuppertal, Germany | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00979420 History of Changes |
| Other Study ID Numbers: | 1100.1535 |
| Study First Received: | September 16, 2009 |
| Results First Received: | May 30, 2012 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Boehringer Ingelheim Pharmaceuticals:
|
treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013