HIV Infections Clinical Trial
Official title:
Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine
| NCT number | NCT00543803 |
| Other study ID # | 1100.1492 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | October 8, 2007 |
| Last updated | May 13, 2014 |
| Start date | February 2006 |
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with 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 Truvada (tenofovir and emtricitabine).
| Status | Completed |
| Enrollment | 334 |
| Est. completion date | |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria - male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I 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. - Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Exclusion criteria - Age < 18 years - Pregnant female patients - Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) 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 aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN. - Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT > 5 ULN 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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | 1100.1492.1 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 1 | 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 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 | Dortmund | |
| Germany | Boehringer Ingelheim Investigational Site | Duisburg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Frankfurt/Main | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Frankfurt/Main | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Frankfurt/Main | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Frankfurt/Main | |
| Germany | Boehringer Ingelheim Investigational Site | Frankfurt/Oder | |
| Germany | Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site | Karlsruhe | |
| Germany | Boehringer Ingelheim Investigational Site | Koblenz | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Köln | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Köln | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Köln | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site | Magdeburg | |
| Germany | Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | Boehringer Ingelheim Investigational Site | Mannheim | |
| Germany | Boehringer Ingelheim Investigational Site 1 | München | |
| Germany | Boehringer Ingelheim Investigational Site 2 | München | |
| Germany | Boehringer Ingelheim Investigational Site 3 | München | |
| Germany | Boehringer Ingelheim Investigational Site 4 | München | |
| Germany | Boehringer Ingelheim Investigational Site 5 | München | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Münster | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Münster | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Münster | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Münster | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site | Oldenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Osnabrueck | |
| Germany | Boehringer Ingelheim Investigational Site | Potsdam | |
| Germany | Boehringer Ingelheim Investigational Site | Saarbruecken | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Stuttgart | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Stuttgart | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Stuttgart | |
| Germany | Boehringer Ingelheim Investigational Site | Troisdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Wiesbaden | |
| Germany | Boehringer Ingelheim Investigational Site | Wuppertal |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment | The change in alanine aminotransferase (ALT) from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | Yes |
| Primary | Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment | The change in asparate aminotransferase (AST) from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | Yes |
| Primary | Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment | The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | Yes |
| Primary | Summary of Change From Baseline in Creatinine to Last Value on Treatment | The change in Creatinine from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Primary | Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment | The change in total cholesterol from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Primary | Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment | The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Primary | Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment | The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Primary | Summary of Change From Baseline in Triglycerides to Last Value on Treatment | The change in triglycerides from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Primary | Summary of Change From Baseline in Glucose to Last Value on Treatment | The change in Glucose from baseline to the last value in treatment | from baseline to last value on treatment in between 36 months | No |
| Secondary | Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment | For calculation of this measure switch patients are included in the total which had no viral load decrease. | from baseline to last value on treatment in between 36 months | No |
| Secondary | Summary of Change From Baseline in CD4+ Count to Last Value on Treatment | from baseline to last value on treatment in between 36 months | No | |
| Secondary | Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator | Total number of patients with investigator defined non-serious drug-related AEs was reported. | from baseline to last value on treatment in between 36 months | Yes |
| Secondary | Investigator's Global Clinical Assessment of Patient General Health Status | Investigators opinion of patients general health condition at baseline versus last evaluation on treatment | from baseline to last value on treatment in between 36 months | No |
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