HIV Infections
Conditions
Keywords
treatment experienced
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). 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
Study Design: observational
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in log10 Viral Load From Baseline to Last Visit | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 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. |
| 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 and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 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. |
| Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug Related Adverse Events | Up to 185 months | Number of participants with drug related Adverse Events (AEs) |
| Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Duration of Intake of Viramune | End of treatment, up to 185 months | Duration of intake of Viramune |
| History of Therapy With Antiretroviral Medication | Baseline | Participants with a history of therapy with antiretroviral medication. |
| Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Up to 185 months | 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. |
| Course of Absolute CD4+ Cell Count | Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months | The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune | 178 |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune | 57 |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune | 60 |
| Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune | 61 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 | 1 | 1 |
| Overall Study | Other reasons not related to Viramune | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Continuous | 50.85 Years STANDARD_DEVIATION 10.54 | 54.21 Years STANDARD_DEVIATION 10.42 | 51.02 Years STANDARD_DEVIATION 7.66 | 53.69 Years STANDARD_DEVIATION 11.05 | 51.91 Years STANDARD_DEVIATION 10.24 |
| Sex/Gender, Customized Female | 36 Participants | 13 Participants | 19 Participants | 9 Participants | 77 Participants |
| Sex/Gender, Customized Male | 142 Participants | 44 Participants | 41 Participants | 51 Participants | 278 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 60 / 356 |
| serious Total, serious adverse events | 35 / 356 |
Outcome results
Primary
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.
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit | 392 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit | 283 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit | 250 CD4+ cells/mm3 |
Primary
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.
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit | 380 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit | 223.5 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit | 228 CD4+ cells/mm3 |
Primary
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.
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Population: Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Change in log10 Viral Load From Baseline to Last Visit | -3.284 log10 copies/ml |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Change in log10 Viral Load From Baseline to Last Visit | 0.000 log10 copies/ml |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Change in log10 Viral Load From Baseline to Last Visit | -2.000 log10 copies/ml |
Primary
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.
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Change in log10 Viral Load From Baseline to Last Visit | -3.260 log10 copies/ml |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Change in log10 Viral Load From Baseline to Last Visit | -0.099 log10 copies/ml |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Change in log10 Viral Load From Baseline to Last Visit | -2.082 log10 copies/ml |
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.
Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 62 Participants |
| Treatment-naive Patients | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 33 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 30 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 3 Participants |
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 83 Participants |
| Treatment-naive Patients | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | Missing | 0 Participants |
| Treatment-naive Patients | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 55 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | Missing | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | <50 copies/ml | 55 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | Missing | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit | >=50 copies/ml | 5 Participants |
Secondary
Course of Absolute CD4+ Cell Count
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
Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Course of Absolute CD4+ Cell Count | 734 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Course of Absolute CD4+ Cell Count | 669 CD4+ cells/mm3 |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Course of Absolute CD4+ Cell Count | 491 CD4+ cells/mm3 |
Secondary
Duration of Intake of Viramune
Duration of intake of Viramune
Time frame: End of treatment, up to 185 months
Population: Treated set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment-naive Patients | Duration of Intake of Viramune | 131 months |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Duration of Intake of Viramune | 124 months |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Duration of Intake of Viramune | 131 months |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Duration of Intake of Viramune | 129 months |
Secondary
History of Therapy With Antiretroviral Medication
Participants with a history of therapy with antiretroviral medication.
Time frame: Baseline
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | History of Therapy With Antiretroviral Medication | Treatment-naive | 178 participants |
| Treatment-naive Patients | History of Therapy With Antiretroviral Medication | Pre-treated | 0 participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | History of Therapy With Antiretroviral Medication | Pre-treated | 57 participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | History of Therapy With Antiretroviral Medication | Treatment-naive | 0 participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | History of Therapy With Antiretroviral Medication | Treatment-naive | 0 participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | History of Therapy With Antiretroviral Medication | Pre-treated | 60 participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | History of Therapy With Antiretroviral Medication | Treatment-naive | 0 participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | History of Therapy With Antiretroviral Medication | Pre-treated | 61 participants |
Secondary
Number of Participants With Drug Related Adverse Events
Number of participants with drug related Adverse Events (AEs)
Time frame: Up to 185 months
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive Patients | Number of Participants With Drug Related Adverse Events | 0 participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Participants With Drug Related Adverse Events | 0 participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Participants With Drug Related Adverse Events | 1 participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Participants With Drug Related Adverse Events | 0 participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 4 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 68 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 12 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 94 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 7 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 17 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 32 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 27 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 27 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 22 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 28 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 2 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 3 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 58 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 12 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 105 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 12 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 40 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 40 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 14 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 1 | 20 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 30 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 2 | 7 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 3 | 8 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 1 | 83 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 4 | 5 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 2 | 29 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 50 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 2 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 4 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 1 | 25 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 22 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 2 | 7 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 21 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 1 | 25 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 4 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 3 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 1 | 25 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 12 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 2 | 17 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade | Grade 4 | 2 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 3 | 13 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 1 | 26 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 4 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 2 | 40 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | < Grade 1 | 11 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 2 | 10 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 3 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 1 | 8 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | < Grade 1 | 7 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 2 | 9 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | < Grade 1 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 1 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 3 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 3 | 9 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 1 | 18 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | < Grade 1 | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 2 | 8 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade | Grade 4 | 0 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 1 | 13 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 4 | 10 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 2 | 2 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 152 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 2 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 4 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 1 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 51 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 2 | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 50 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 1 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 4 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 1 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 49 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 2 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade | Grade 4 | 5 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 1 | 6 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 2 | 1 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 171 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 2 | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 1 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 53 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 2 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 58 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 1 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 1 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 54 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 2 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade | Grade 4 | 2 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 3 | 18 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 1 | 30 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 2 | 11 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 17 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 2 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 3 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 1 | 6 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 9 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 2 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 1 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 3 | 5 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 3 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 1 | 8 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 9 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 2 | 13 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
Secondary
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.
Time frame: Up to 185 months
Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 2 | 15 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 72 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 3 | 3 Participants |
| Treatment-naive Patients | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 1 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 2 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 1 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 4 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 27 Participants |
| Pre-treated Patients With Baseline HIV RNA<50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 3 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 1 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 4 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 3 | 1 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 2 | 2 Participants |
| Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 17 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 4 | 3 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | < Grade 1 | 26 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 1 | 0 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 2 | 4 Participants |
| Pre-treated Patients With Baseline HIV RNA Not Documented | Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade | Grade 3 | 4 Participants |