Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 265
- Locations
- 34
- Primary Endpoint
- Number of Patients With Virologic Response (VR) After 36 Months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.
Detailed Description
Time Perspective: retro- and prospective
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Patients With Virologic Response (VR) After 36 Months
Time Frame: 36 months
VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.
Secondary Outcomes
- Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data ( ALT) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Viral Load After 36 Months From Baseline(Baseline and 36 months)
- Changes in the CD4+ Cell Count After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (AST) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline(Baseline and 36 months)