Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 334
- Locations
- 16
- Primary Endpoint
- Summary of Change From Baseline in Creatinine to Last Value on Treatment
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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
The change in total cholesterol from baseline to the last value in treatment
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
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
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
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
Time Frame: 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 Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
Time Frame: 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 Triglycerides to Last Value on Treatment
Time Frame: 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
Time Frame: from baseline to last value on treatment in between 36 months
The change in Glucose from baseline to the last value in treatment
Secondary Outcomes
- 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)
- 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)
- Investigator's Global Clinical Assessment of Patient General Health Status(from baseline to last value on treatment in between 36 months)