Trial Outcomes & Findings for Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients (NCT NCT00876733)
NCT ID: NCT00876733
Last Updated: 2015-01-16
Results Overview
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Recruitment status
COMPLETED
Target enrollment
605 participants
Primary outcome timeframe
36 months
Results posted on
2015-01-16
Participant Flow
Participant milestones
| Measure |
Treatment-naive Patients
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
288
|
203
|
93
|
21
|
|
Overall Study
COMPLETED
|
197
|
161
|
63
|
14
|
|
Overall Study
NOT COMPLETED
|
91
|
42
|
30
|
7
|
Reasons for withdrawal
| Measure |
Treatment-naive Patients
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
34
|
20
|
10
|
3
|
|
Overall Study
Lack of Efficacy
|
17
|
9
|
10
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
10
|
3
|
2
|
|
Overall Study
Data not available
|
14
|
3
|
7
|
1
|
Baseline Characteristics
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Baseline characteristics by cohort
| Measure |
Treatment-naive Patients
n=288 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=203 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=93 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=21 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Total
n=605 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
41.6 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
538 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=21 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=288 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=203 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=93 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Patients with any AE
|
10 participants
|
168 participants
|
110 participants
|
51 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Patients with serious AEs
|
0 participants
|
17 participants
|
12 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from FAS with values for viral load at baseline and after 12 months.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=238 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=181 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=78 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Viral Load After 12 Months From Baseline.
|
—
|
-3.3 Log10 copies/ml
Standard Deviation 1.3
|
-0.1 Log10 copies/ml
Standard Deviation 0.8
|
-1.9 Log10 copies/ml
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from FAS with values for viral load at baseline and after 36 months.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=231 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=185 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=74 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Viral Load After 36 Months From Baseline.
|
—
|
-3.4 Log10 copies/ml
Standard Deviation 1.4
|
-0.2 Log10 copies/ml
Standard Deviation 1.1
|
-2.1 Log10 copies/ml
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from FAS with values for CD4+ at baseline and after 12 months.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=2 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=238 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=178 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=76 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
|
128.0 cells/mm^3
Standard Deviation 223.4
|
188.7 cells/mm^3
Standard Deviation 165.0
|
54.6 cells/mm^3
Standard Deviation 145.3
|
82.8 cells/mm^3
Standard Deviation 269.5
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from FAS with values for CD4+ at baseline and after 36 months.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=2 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=230 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=181 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=72 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the CD4+ Cell Count After 36 Months From Baseline.
|
63.5 cells/mm^3
Standard Deviation 152.0
|
223.7 cells/mm^3
Standard Deviation 200.4
|
2.8 cells/mm^3
Standard Deviation 221.3
|
116.0 cells/mm^3
Standard Deviation 317.7
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=5 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=139 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=128 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=42 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
|
16.4 mg/dL
Standard Deviation 9.7
|
25.2 mg/dL
Standard Deviation 36.2
|
-3.0 mg/dL
Standard Deviation 43.2
|
15.8 mg/dL
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=4 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=95 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=76 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=26 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
|
-13.2 mg/dL
Standard Deviation 29.1
|
12.7 mg/dL
Standard Deviation 14.3
|
4.2 mg/dL
Standard Deviation 15.0
|
10.9 mg/dL
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=4 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=95 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=75 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=25 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
|
13.6 mg/dL
Standard Deviation 10.1
|
12.1 mg/dL
Standard Deviation 29.6
|
2.4 mg/dL
Standard Deviation 35.7
|
14.4 mg/dL
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Triglycerides at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=5 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=139 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=130 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=38 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
|
16.3 mg/dL
Standard Deviation 47.2
|
7.9 mg/dL
Standard Deviation 106.7
|
-61.6 mg/dL
Standard Deviation 180.2
|
-24.0 mg/dL
Standard Deviation 78.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=4 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=136 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=134 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=44 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
|
-8.4 mg/dL
Standard Deviation 9.2
|
0.2 mg/dL
Standard Deviation 20.6
|
-3.6 mg/dL
Standard Deviation 16.9
|
0.3 mg/dL
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for ALT at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=7 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=175 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=152 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=49 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (ALT) After 12 Months From Baseline
|
9.7 U/L
Standard Deviation 33.0
|
5.6 U/L
Standard Deviation 20.5
|
10.2 U/L
Standard Deviation 28.8
|
7.0 U/L
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for AST at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=7 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=173 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=146 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=48 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (AST) After 12 Months From Baseline
|
8.3 U/L
Standard Deviation 32.4
|
1.7 U/L
Standard Deviation 19.1
|
4.4 U/L
Standard Deviation 24.7
|
3.0 U/L
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Gamma GT at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=7 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=175 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=152 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=49 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
|
9.1 U/L
Standard Deviation 42.6
|
32.9 U/L
Standard Deviation 72.4
|
25.4 U/L
Standard Deviation 57.7
|
23.7 U/L
Standard Deviation 62.3
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Creatinine at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=7 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=176 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=152 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=47 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
|
0.0 mg/dL
Standard Deviation 0.2
|
0.0 mg/dL
Standard Deviation 0.1
|
0.0 mg/dL
Standard Deviation 0.1
|
0.0 mg/dL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=7 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=177 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=147 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=45 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
|
0.5 g/dL
Standard Deviation 1.1
|
0.6 g/dL
Standard Deviation 1.1
|
0.3 g/dL
Standard Deviation 1.2
|
0.3 g/dL
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=2 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=82 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=66 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=25 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
|
41.1 mg/dL
Standard Deviation 12.9
|
24.1 mg/dL
Standard Deviation 39.0
|
2.0 mg/dL
Standard Deviation 44.4
|
24.2 mg/dL
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=2 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=53 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=42 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=15 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
|
-19.6 mg/dL
Standard Deviation 38.7
|
11.0 mg/dL
Standard Deviation 21.4
|
4.4 mg/dL
Standard Deviation 20.7
|
11.1 mg/dL
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=2 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=53 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=40 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=15 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
|
22.7 mg/dL
Standard Deviation 27.9
|
12.4 mg/dL
Standard Deviation 25.8
|
15.8 mg/dL
Standard Deviation 38.1
|
23.8 mg/dL
Standard Deviation 44.7
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Triglycerides at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=1 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=83 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=67 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=25 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
|
34.2 mg/dL
|
-3.4 mg/dL
Standard Deviation 91.3
|
-73.7 mg/dL
Standard Deviation 252.6
|
-17.2 mg/dL
Standard Deviation 98.0
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=1 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=78 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=71 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=23 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
|
-7.2 mg/dL
|
1.6 mg/dL
Standard Deviation 27.2
|
0.0 mg/dL
Standard Deviation 19.9
|
0.7 mg/dL
Standard Deviation 36.4
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for ALT at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=3 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=103 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=76 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (ALT) After 36 Months From Baseline
|
5.2 U/L
Standard Deviation 26.1
|
16.2 U/L
Standard Deviation 107.1
|
4.0 U/L
Standard Deviation 33.7
|
11.8 U/L
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for AST at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=3 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=100 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=75 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=29 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (AST) After 36 Months From Baseline
|
-2.7 U/L
Standard Deviation 19.6
|
7.3 U/L
Standard Deviation 75.3
|
0.1 U/L
Standard Deviation 24.6
|
5.5 U/L
Standard Deviation 27.1
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Gamma GT at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=3 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=104 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=76 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
|
12.9 U/L
Standard Deviation 48.1
|
52.3 U/L
Standard Deviation 102.5
|
45.0 U/L
Standard Deviation 112.6
|
50.3 U/L
Standard Deviation 50.3
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Creatinine at baseline and at month 12.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=3 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=103 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=74 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
|
0.0 mg/dL
Standard Deviation 0.1
|
0.0 mg/dL
Standard Deviation 0.2
|
0.0 mg/dL
Standard Deviation 0.1
|
0.0 mg/dL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.
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.
Outcome measures
| Measure |
Patients With Baseline Viral Load Not Documented
n=3 Participants
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Treatment-naive Patients
n=103 Participants
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=73 Participants
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
|---|---|---|---|---|
|
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
|
-0.1 g/dL
Standard Deviation 1.6
|
0.7 g/dL
Standard Deviation 0.9
|
0.2 g/dL
Standard Deviation 1.2
|
0.5 g/dL
Standard Deviation 1.4
|
Adverse Events
Treatment-naive Patients
Serious events: 17 serious events
Other events: 51 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Patients With Baseline Viral Load Not Documented
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-naive Patients
n=288 participants at risk
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=203 participants at risk
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=93 participants at risk
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=21 participants at risk
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.69%
2/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
General disorders
Chest pain
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
General disorders
Device occlusion
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
General disorders
Local swelling
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
General disorders
Tenderness
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Acute hepatitis C
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Cellulitis
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Herpes zoster
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Myelitis
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Investigations
Biopsy
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Investigations
Hepatic enzyme abnormal
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Investigations
Transaminases increased
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer recurrent
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Acute stress disorder
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Alcoholism
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
2.2%
2/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Reproductive system and breast disorders
Epididymitis
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Surgical and medical procedures
Bursa removal
|
0.00%
0/288 • 36 months
|
0.00%
0/203 • 36 months
|
1.1%
1/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Surgical and medical procedures
Laparoscopic surgery
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Surgical and medical procedures
Laser therapy
|
0.35%
1/288 • 36 months
|
0.00%
0/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/288 • 36 months
|
0.49%
1/203 • 36 months
|
0.00%
0/93 • 36 months
|
0.00%
0/21 • 36 months
|
Other adverse events
| Measure |
Treatment-naive Patients
n=288 participants at risk
Patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=203 participants at risk
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
n=93 participants at risk
Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=21 participants at risk
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
16/288 • 36 months
|
6.9%
14/203 • 36 months
|
7.5%
7/93 • 36 months
|
9.5%
2/21 • 36 months
|
|
Infections and infestations
Bronchitis
|
4.9%
14/288 • 36 months
|
10.3%
21/203 • 36 months
|
9.7%
9/93 • 36 months
|
4.8%
1/21 • 36 months
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
30/288 • 36 months
|
6.4%
13/203 • 36 months
|
16.1%
15/93 • 36 months
|
4.8%
1/21 • 36 months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
15/288 • 36 months
|
1.5%
3/203 • 36 months
|
3.2%
3/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Investigations
Transaminase increased
|
5.6%
16/288 • 36 months
|
1.5%
3/203 • 36 months
|
2.2%
2/93 • 36 months
|
0.00%
0/21 • 36 months
|
|
Vascular disorders
Hypertension
|
2.8%
8/288 • 36 months
|
3.0%
6/203 • 36 months
|
2.2%
2/93 • 36 months
|
9.5%
2/21 • 36 months
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER