Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00543803
First received: October 8, 2007
Last updated: February 27, 2014
Last verified: February 2014

October 8, 2007
February 27, 2014
February 2006
December 2009   (final data collection date for primary outcome measure)
  • Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
  • Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in asparate aminotransferase (AST) from baseline to the last value in treatment
  • Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
  • Summary of Change From Baseline in Creatinine to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Creatinine from baseline to the last value in treatment
  • Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in total cholesterol from baseline to the last value in treatment
  • Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
  • Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
  • Summary of Change From Baseline in Triglycerides to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in triglycerides from baseline to the last value in treatment
  • Summary of Change From Baseline in Glucose to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    The change in Glucose from baseline to the last value in treatment
safety
Complete list of historical versions of study NCT00543803 on ClinicalTrials.gov Archive Site
  • Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    For calculation of this measure switch patients are included in the total which had no viral load decrease.
  • Summary of Change From Baseline in CD4+ Count to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
  • Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
    Total number of patients with investigator defined non-serious drug-related AEs was reported.
  • Investigator's Global Clinical Assessment of Patient General Health Status [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
    Investigators opinion of patients general health condition at baseline versus last evaluation on treatment
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Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HIV Patients

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
Not Provided
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00543803
1100.1492
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP