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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00979420
First received: September 16, 2009
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: May 30, 2012  
Study Type: Observational
Study Design: Time Perspective: Retrospective
Condition: HIV Infections

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Participant Flow:   Overall Study
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
STARTED     178     57     60     61  
COMPLETED     171     57     59     59  
NOT COMPLETED     7     0     1     2  
Adverse Event                 1                 0                 0                 0  
Lack of Efficacy                 3                 0                 1                 1  
Other reasons not related to Viramune                 3                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set - all patients receiving at least one dose of study medication

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune
Total Total of all reporting groups

Baseline Measures
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented     Total  
Number of Participants  
[units: participants]
  178     57     60     61     356  
Age  
[units: Years]
Mean ± Standard Deviation
  50.85  ± 10.54     54.21  ± 10.42     51.02  ± 7.66     53.69  ± 11.05     51.91  ± 10.24  
Gender, Customized  
[units: Participants]
         
Male     142     44     41     51     278  
Female     36     13     19     9     77  
Missing     0     0     0     1     1  



  Outcome Measures
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1.  Primary:   Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Change in log10 Viral Load From Baseline to Last Visit
Measure Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  86     57     60  
Change in log10 Viral Load From Baseline to Last Visit  
[units: log10 copies/ml]
Median ( Full Range )
  -3.260  
  ( -5.61 to 2.25 )  
  -0.099  
  ( -1.69 to 0.70 )  
  -2.082  
  ( -5.82 to 0.40 )  

No statistical analysis provided for Change in log10 Viral Load From Baseline to Last Visit



2.  Primary:   Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Measure Description No text entered.
Time Frame Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  86     57     60  
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit  
[units: Participants]
     
<50 copies/ml     83     55     55  
>=50 copies/ml     3     2     5  
Missing     0     0     0  

No statistical analysis provided for Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit



3.  Primary:   Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
Measure Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  83     56     60  
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit  
[units: CD4+ cells/mm3]
Median ( Full Range )
  380  
  ( -323 to 1749 )  
  223.5  
  ( -328 to 1104 )  
  228  
  ( -360 to 1004 )  

No statistical analysis provided for Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit



4.  Primary:   Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Change in log10 Viral Load From Baseline to Last Visit
Measure Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  63     34     33  
Change in log10 Viral Load From Baseline to Last Visit  
[units: log10 copies/ml]
Median ( Full Range )
  -3.284  
  ( -5.61 to 0.00 )  
  0.000  
  ( -0.41 to 0.70 )  
  -2.000  
  ( -5.824 to 0.40 )  

No statistical analysis provided for Change in log10 Viral Load From Baseline to Last Visit



5.  Primary:   Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Measure Description No text entered.
Time Frame Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  63     34     33  
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit  
[units: Participants]
     
<50 copies/ml     62     33     30  
>=50 copies/ml     1     1     3  

No statistical analysis provided for Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit



6.  Primary:   Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

Measure Type Primary
Measure Title Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
Measure Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  61     33     33  
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit  
[units: CD4+ cells/mm3]
Median ( Full Range )
  392  
  ( -323 to 1027 )  
  283  
  ( -234 to 1104 )  
  250  
  ( -266 to 987 )  

No statistical analysis provided for Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit



7.  Secondary:   Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  90     28     21     37  
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade  
[units: Participants]
       
< Grade 1     11     7     4     2  
Grade 1     26     8     4     18  
Grade 2     40     10     9     8  
Grade 3     13     3     4     9  
Grade 4     0     0     0     0  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade



8.  Secondary:   Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  76     23     18     33  
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     17     9     5     9  
Grade 1     30     6     5     8  
Grade 2     11     5     3     13  
Grade 3     18     3     5     3  
Grade 4     0     0     0     0  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade



9.  Secondary:   Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  91     28     21     37  
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     72     27     17     26  
Grade 1     0     0     0     0  
Grade 2     15     1     2     4  
Grade 3     3     0     1     4  
Grade 4     1     0     1     3  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade



10.  Secondary:   Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  175     57     59     59  
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     50     22     21     12  
Grade 1     83     25     25     25  
Grade 2     29     5     7     17  
Grade 3     8     1     1     3  
Grade 4     5     4     5     2  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade



11.  Secondary:   Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     59     58  
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     94     32     27     28  
Grade 1     68     17     27     22  
Grade 2     12     7     3     4  
Grade 3     4     1     1     2  
Grade 4     0     0     1     2  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade



12.  Secondary:   Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     59     58  
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     105     40     40     30  
Grade 1     58     12     14     20  
Grade 2     12     5     3     7  
Grade 3     3     0     1     0  
Grade 4     0     0     1     1  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade



13.  Secondary:   Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     60     59  
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     152     51     50     49  
Grade 1     13     3     5     3  
Grade 2     2     0     2     1  
Grade 3     1     0     0     1  
Grade 4     10     3     3     5  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade



14.  Secondary:   Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
Measure Description 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.
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     56     60     59  
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
       
< Grade 1     171     53     58     54  
Grade 1     6     1     1     3  
Grade 2     1     2     0     0  
Grade 3     0     0     0     0  
Grade 4     0     0     1     2  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade



15.  Secondary:   Duration of Intake of Viramune   [ Time Frame: End of treatment, up to 185 months ]

Measure Type Secondary
Measure Title Duration of Intake of Viramune
Measure Description Duration of intake of Viramune
Time Frame End of treatment, up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     60     61  
Duration of Intake of Viramune  
[units: months]
Median ( Full Range )
  131  
  ( 30 to 185 )  
  124  
  ( 43 to 149 )  
  131  
  ( 14 to 159 )  
  129  
  ( 105 to 161 )  

No statistical analysis provided for Duration of Intake of Viramune



16.  Secondary:   History of Therapy With Antiretroviral Medication   [ Time Frame: Baseline ]

Measure Type Secondary
Measure Title History of Therapy With Antiretroviral Medication
Measure Description Participants with a history of therapy with antiretroviral medication.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     60     61  
History of Therapy With Antiretroviral Medication  
[units: participants]
       
Treatment-naive     178     0     0     0  
Pre-treated     0     57     60     61  

No statistical analysis provided for History of Therapy With Antiretroviral Medication



17.  Secondary:   Course of Absolute CD4+ Cell Count   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months ]

Measure Type Secondary
Measure Title Course of Absolute CD4+ Cell Count
Measure Description The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml  
Number of Participants Analyzed  
[units: participants]
  63     33     33  
Course of Absolute CD4+ Cell Count  
[units: CD4+ cells/mm3]
Median ( Full Range )
  734  
  ( 96 to 1526 )  
  669  
  ( 189 to 1479 )  
  491  
  ( 237 to 1326 )  

No statistical analysis provided for Course of Absolute CD4+ Cell Count



18.  Secondary:   Number of Participants With Drug Related Adverse Events   [ Time Frame: Up to 185 months ]

Measure Type Secondary
Measure Title Number of Participants With Drug Related Adverse Events
Measure Description Number of participants with drug related Adverse Events (AEs)
Time Frame Up to 185 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
  178     57     60     61  
Number of Participants With Drug Related Adverse Events  
[units: participants]
  0     0     1     0  

No statistical analysis provided for Number of Participants With Drug Related Adverse Events




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00979420     History of Changes
Other Study ID Numbers: 1100.1535
Study First Received: September 16, 2009
Results First Received: May 30, 2012
Last Updated: June 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices