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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00543803
• Lead Sponsor: Boehringer Ingelheim

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-10-08
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2009-12
• Results First Submitted: 2010-12-17
• Results First Submitted QC: 2010-12-17
• Results First Posted: 2011-01-13
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summary of Change From Baseline in Creatinine to Last Value on Treatment	from baseline to last value on treatment in between 36 months	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	from baseline to last value on treatment in between 36 months	The change in total 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	from baseline to last value on treatment in between 36 months	The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment	from baseline to last value on treatment in between 36 months	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	from baseline to last value on treatment in between 36 months	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	from baseline to last value on treatment in between 36 months	The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment	from baseline to last value on treatment in between 36 months	The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Triglycerides to Last Value on Treatment	from baseline to last value on treatment in between 36 months	The change in triglycerides from baseline to the last value in treatment
Summary of Change From Baseline in Glucose to Last Value on Treatment	from baseline to last value on treatment in between 36 months	The change in Glucose from baseline to the last value in treatment

Secondary Outcome Measures

Name	Time	Method
Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment	from baseline to last value on treatment in between 36 months	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	from baseline to last value on treatment in between 36 months
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator	from baseline to last value on treatment in between 36 months	Total number of patients with investigator defined non-serious drug-related AEs was reported.
Investigator's Global Clinical Assessment of Patient General Health Status	from baseline to last value on treatment in between 36 months	Investigators opinion of patients general health condition at baseline versus last evaluation on treatment

Trial Locations

Locations (16)

Boehringer Ingelheim Investigational Site; 🇩🇪 Wuppertal, Germany

Boehringer Ingelheim Investigational Site 1; 🇩🇪 Stuttgart, Germany

Boehringer Ingelheim Investigational Site 10; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 7; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 9; 🇩🇪 Berlin, Germany

1100.1492.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 6; 🇩🇪 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; 🇩🇪 Stuttgart, Germany

Boehringer Ingelheim Investigational Site 3; 🇩🇪 Stuttgart, Germany

Boehringer Ingelheim Investigational Site 4; 🇩🇪 Münster, Germany

Boehringer Ingelheim Investigational Site 8; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 5; 🇩🇪 München, Germany