Non-interventional Observational Study With Viramune in HIV to Evaluate Gender Specific Data
| Tracking Information | |||||
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| First Received Date ICMJE | June 1, 2010 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01134939 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Lessening (or maintenance) of the virus load to a value that is below the detection limit. Change in the CD4 cell count from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non-interventional Observational Study With Viramune in HIV to Evaluate Gender Specific Data | ||||
| Official Title ICMJE | Non-interventional Observational Study With Viramune Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data. | ||||
| 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. |
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| Detailed Description | Time Perspective: retro- and prospective |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | HIV-infected women and men | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 342 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01134939 | ||||
| Other Study ID Numbers ICMJE | 1100.1536 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim Pharmaceuticals | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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