Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
| Tracking Information | |||||
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| First Received Date ICMJE | March 20, 2009 | ||||
| Last Updated Date | September 19, 2012 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 48 weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00876733 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Variations in laboratory from normal levels as well as changes in comparison to baseline values. Changes in the CD4 cell count from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Variations in laboratory from normal levels as well as changes in comparison to baseline values. Changes in the CD4 cell conunt from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients | ||||
| Official Title ICMJE | Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients | ||||
| 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). |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | |||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) | HIV treatment | ||||
| Publications * | |||||
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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 | 600 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: To construct a treatment option with Viramune (nevirapine) and antiretroviral, e.g. Combivir (fixed dose combination of Zidovudine and Lamivudine), Kivexa (fixed dose combination of Abacavir and Lamivudine) or Truvada (fixed dose combination of tenofovir and emtricitabine) in male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with protease inhibitors has failed, or who have to switch their previous treatment from protease inhibitor or nucleosidaI reverse transcriptase inhibitor due to side effects or intolerability after achieving suppression of viral load below the limit of detection. Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency. Exclusion criteria: pAge < 18 years Pregnant female patients Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or antiretroviral in combination with Viramune, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine). Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine. Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment GOT (Glutamic Oxaloacetic Transaminase) or GPT (Glutamic Pyruvate Transaminase) > 5 upper limit of normal until baseline GOT/GPT are stabilised < 5 upper limit of normal. Viramune (nevirapine) should not be readministered in patients who previously had GOT or GPT (Liver enzymes) > 5 ULN (upper limit of normal) during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine) Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended. |
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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 | NCT00876733 | ||||
| Other Study ID Numbers ICMJE | 1100.1524 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | Boehringer Ingelheim Pharmaceuticals | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | September 2012 | ||||
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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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