An observational study in HIV Infections, sponsored by Boehringer Ingelheim. Completed at 66 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-16.
Sponsored by Boehringer Ingelheim · Observational
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 605 is above the median of 200 across 731 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Time frame: 36 months
Changes in the Viral Load After 12 Months From Baseline.
The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
Time frame: Baseline and 12 months
Changes in the Viral Load After 36 Months From Baseline.
The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.
Time frame: Baseline and 36 months
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
Time frame: Baseline and 12 months
Changes in the CD4+ Cell Count After 36 Months From Baseline.
The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (ALT) After 12 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (AST) After 12 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (ALT) After 36 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (AST) After 36 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
| Milestone | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Started | 288 | 203 | 93 | 21 |
| Completed | 197 | 161 | 63 | 14 |
| Not completed | 91 | 42 | 30 | 7 |
| Withdrew: Adverse event | 34 | 20 | 10 | 3 |
| Withdrew: Lack of efficacy | 17 | 9 | 10 | 1 |
| Withdrew: Lost to follow-up | 26 | 10 | 3 | 2 |
| Withdrew: Data not available | 14 | 3 | 7 | 1 |
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
| participants | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Patients with any AE | 168 | 110 | 51 | 10 |
| Patients with serious AEs | 17 | 12 | 5 | 0 |
The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
| Log10 copies/ml | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Viral Load After 12 Months From Baseline. | -3.3 ± 1.3 | -0.1 ± 0.8 | -1.9 ± 1.7 | — |
The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.
| Log10 copies/ml | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Viral Load After 36 Months From Baseline. | -3.4 ± 1.4 | -0.2 ± 1.1 | -2.1 ± 1.8 | — |
The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
| cells/mm^3 | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | 188.7 ± 165.0 | 54.6 ± 145.3 | 82.8 ± 269.5 | 128.0 ± 223.4 |
The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
| cells/mm^3 | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the CD4+ Cell Count After 36 Months From Baseline. | 223.7 ± 200.4 | 2.8 ± 221.3 | 116.0 ± 317.7 | 63.5 ± 152.0 |
The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | 25.2 ± 36.2 | -3.0 ± 43.2 | 15.8 ± 32.8 | 16.4 ± 9.7 |
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | 12.7 ± 14.3 | 4.2 ± 15.0 | 10.9 ± 14.9 | -13.2 ± 29.1 |
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | 12.1 ± 29.6 | 2.4 ± 35.7 | 14.4 ± 30.5 | 13.6 ± 10.1 |
The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | 7.9 ± 106.7 | -61.6 ± 180.2 | -24.0 ± 78.9 | 16.3 ± 47.2 |
The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | 0.2 ± 20.6 | -3.6 ± 16.9 | 0.3 ± 24.9 | -8.4 ± 9.2 |
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (ALT) After 12 Months From Baseline | 5.6 ± 20.5 | 10.2 ± 28.8 | 7.0 ± 28.4 | 9.7 ± 33.0 |
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (AST) After 12 Months From Baseline | 1.7 ± 19.1 | 4.4 ± 24.7 | 3.0 ± 20.9 | 8.3 ± 32.4 |
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | 32.9 ± 72.4 | 25.4 ± 57.7 | 23.7 ± 62.3 | 9.1 ± 42.6 |
The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | 0.0 ± 0.1 | 0.0 ± 0.1 | 0.0 ± 0.1 | 0.0 ± 0.2 |
The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| g/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | 0.6 ± 1.1 | 0.3 ± 1.2 | 0.3 ± 0.9 | 0.5 ± 1.1 |
The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | 24.1 ± 39.0 | 2.0 ± 44.4 | 24.2 ± 42.4 | 41.1 ± 12.9 |
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | 11.0 ± 21.4 | 4.4 ± 20.7 | 11.1 ± 11.9 | -19.6 ± 38.7 |
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | 12.4 ± 25.8 | 15.8 ± 38.1 | 23.8 ± 44.7 | 22.7 ± 27.9 |
The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | -3.4 ± 91.3 | -73.7 ± 252.6 | -17.2 ± 98.0 | 34.2 |
The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | 1.6 ± 27.2 | 0.0 ± 19.9 | 0.7 ± 36.4 | -7.2 |
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (ALT) After 36 Months From Baseline | 16.2 ± 107.1 | 4.0 ± 33.7 | 11.8 ± 27.7 | 5.2 ± 26.1 |
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (AST) After 36 Months From Baseline | 7.3 ± 75.3 | 0.1 ± 24.6 | 5.5 ± 27.1 | -2.7 ± 19.6 |
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| U/L | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | 52.3 ± 102.5 | 45.0 ± 112.6 | 50.3 ± 50.3 | 12.9 ± 48.1 |
The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| mg/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | 0.0 ± 0.2 | 0.0 ± 0.1 | 0.0 ± 0.1 | 0.0 ± 0.1 |
The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| g/dL | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | 0.7 ± 0.9 | 0.2 ± 1.2 | 0.5 ± 1.4 | -0.1 ± 1.6 |
Collected over 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment-naive Patients | — | 17/288 (5.9%) | 51/288 (17.7%) |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | — | 12/203 (5.9%) | 33/203 (16.3%) |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | — | 5/93 (5.4%) | 22/93 (23.7%) |
| Patients With Baseline Viral Load Not Documented | — | 0/21 (0%) | 3/21 (14.3%) |
| Event | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| DepressionPsychiatric disorders | 0/288 | 0/203 | 2/93 | 0/21 |
| Acute hepatitis CInfections and infestations | 1/288 | 0/203 | 1/93 | 0/21 |
| BronchopneumoniaInfections and infestations | 0/288 | 0/203 | 1/93 | 0/21 |
| Herpes zosterInfections and infestations | 1/288 | 0/203 | 1/93 | 0/21 |
| Meningoencephalitis herpeticInfections and infestations | 0/288 | 0/203 | 1/93 | 0/21 |
| Joint dislocationInjury, poisoning and procedural complications | 0/288 | 0/203 | 1/93 | 0/21 |
| ConvulsionNervous system disorders | 0/288 | 0/203 | 1/93 | 0/21 |
| Anxiety disorderPsychiatric disorders | 0/288 | 0/203 | 1/93 | 0/21 |
| Bursa removalSurgical and medical procedures | 0/288 | 0/203 | 1/93 | 0/21 |
| DiarrhoeaGastrointestinal disorders | 2/288 | 1/203 | 0/93 | 0/21 |
| Event | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 30/288 | 13/203 | 15/93 | 1/21 |
| BronchitisInfections and infestations | 14/288 | 21/203 | 9/93 | 1/21 |
| DiarrhoeaGastrointestinal disorders | 16/288 | 14/203 | 7/93 | 2/21 |
| HypertensionVascular disorders | 8/288 | 6/203 | 2/93 | 2/21 |
| Transaminase increasedInvestigations | 16/288 | 3/203 | 2/93 | 0/21 |
| Upper respiratory tract infectionInfections and infestations | 15/288 | 3/203 | 3/93 | 0/21 |
Treated set (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.
| Age, Continuous(years) | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented | Total |
|---|---|---|---|---|---|
| Mean | 40.2 ± 9.9 | 43.8 ± 9.6 | 40.9 ± 9.4 | 43.6 ± 7.8 | 41.6 ± 9.8 |
| Sex: Female, Male(Participants) | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented | Total |
|---|---|---|---|---|---|
| Female | 32 | 29 | 6 | 0 | 67 |
| Male | 256 | 174 | 87 | 21 | 538 |
The record gives a start of Mar 2009, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2015, 1 year 1 month after primary completion.
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