Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

Study Overview
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Brief Summary
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The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. 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 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
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Study Design: observational

Official Title
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Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843) Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in log10 Viral Load From Baseline to Last Visit | Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load. | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 
| Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit |  | Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 
| Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit | Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells. | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 
| Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit | Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells. | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening. | Up to 185 months | 
| Duration of Intake of Viramune | Duration of intake of Viramune | End of treatment, up to 185 months | 
| History of Therapy With Antiretroviral Medication | Participants with a history of therapy with antiretroviral medication. | Baseline | 
| Course of Absolute CD4+ Cell Count | The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit. | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months | 
| Number of Participants With Drug Related Adverse Events | Number of participants with drug related Adverse Events (AEs) | Up to 185 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment experienced