Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

Study Overview
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Brief Summary
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This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or 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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).

Official Title
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Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: male and female 18 years or older written informed consent The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC Exclusion criteria: Pregnant patients The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC

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 |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Viral Load After 12 Months From Baseline. | The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load. | Baseline and 12 months | 
| Changes in the Viral Load After 36 Months From Baseline. | The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load. | Baseline and 36 months | 
| Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count. | Baseline and 12 months | 
| Changes in the CD4+ Cell Count After 36 Months From Baseline. | The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count. | Baseline and 36 months | 
| Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (ALT) After 12 Months From Baseline | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (AST) After 12 Months From Baseline | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 12 months | 
| Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (ALT) After 36 Months From Baseline | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (AST) After 36 Months From Baseline | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months | 
| Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. | Baseline and 36 months |