Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

• Number of Patients With Virologic Response (VR) After 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]

  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.

  
  

• Changes in the Viral Load After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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.
  
  
• Changes in the CD4+ Cell Count After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  The change in the Cluster of differentiation 4 (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.
  
  
• Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data ( ALT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (AST) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  
• Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
  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. .
  
  

Time Perspective:

retro- and prospective