Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
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| ClinicalTrials.gov Identifier: NCT01134939 |
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Recruitment Status
:
Completed
First Posted
: June 2, 2010
Results First Posted
: January 21, 2015
Last Update Posted
: January 21, 2015
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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.
| Condition or disease |
|---|
| HIV Infections |
Time Perspective:
retro- and prospective
| Study Type : | Observational |
| Actual Enrollment : | 265 participants |
| Observational Model: | Cohort |
| Official Title: | Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data. |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Nevirapine
U.S. FDA Resources
| Group/Cohort |
|---|
| HIV-infected women and men |
Primary Outcome Measures
:
- Number of Patients With Virologic Response (VR) After 36 Months [ Time Frame: 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
:
- Changes in the Viral Load After 36 Months From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 (HDL Cholesterol) After 36 Months From Baseline [ Time Frame: 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 (LDL Cholesterol) After 36 Months From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ( ALT) After 36 Months From Baseline [ Time Frame: 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 (AST) After 36 Months From Baseline [ Time Frame: 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 (Gamma-GT) After 36 Months From Baseline [ Time Frame: 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 (Creatinine) After 36 Months From Baseline [ Time Frame: 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 (Haemoglobin) After 36 Months From Baseline [ Time Frame: 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. .
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134939
Locations
| Germany | |
| Boehringer Ingelheim Investigational Site 23 | |
| Aachen, Germany | |
| Boehringer Ingelheim Investigational Site 10 | |
| 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 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 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 | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01134939 History of Changes |
| Other Study ID Numbers: |
1100.1536 |
| First Posted: | June 2, 2010 Key Record Dates |
| Results First Posted: | January 21, 2015 |
| Last Update Posted: | January 21, 2015 |
| Last Verified: | January 2015 |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |