Trial Outcomes & Findings for Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data (NCT NCT01134939)
NCT ID: NCT01134939
Last Updated: 2015-01-21
Results Overview
VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.
Recruitment status
COMPLETED
Target enrollment
265 participants
Primary outcome timeframe
36 months
Results posted on
2015-01-21
Participant Flow
Participant milestones
| Measure |
Treatment-naive Female Patients
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
42
|
51
|
46
|
33
|
14
|
19
|
1
|
|
Overall Study
COMPLETED
|
42
|
24
|
41
|
32
|
23
|
5
|
10
|
1
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
10
|
14
|
10
|
9
|
9
|
0
|
Reasons for withdrawal
| Measure |
Treatment-naive Female Patients
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
4
|
5
|
5
|
5
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
5
|
1
|
0
|
3
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Termination page not available
|
4
|
6
|
5
|
8
|
0
|
3
|
7
|
0
|
Baseline Characteristics
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
Baseline characteristics by cohort
| Measure |
Treatment-naive Female Patients
n=59 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=42 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=51 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=46 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=33 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=14 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=19 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
n=1 Participants
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
39.2 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
39.2 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
44.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 8.0 • n=31 Participants
|
43.2 years
STANDARD_DEVIATION 10.7 • n=30 Participants
|
38.9 years
STANDARD_DEVIATION 8.9 • n=3 Participants
|
50.0 years
n=6 Participants
|
39.7 years
STANDARD_DEVIATION 9.6 • n=114 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
162 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
103 Participants
n=114 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.
VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.
Outcome measures
| Measure |
Treatment-naive Female Patients
n=58 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=42 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=51 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=46 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=33 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=14 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=18 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
n=1 Participants
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Virologic Response (VR) After 36 Months
|
44 participants
|
30 participants
|
46 participants
|
40 participants
|
25 participants
|
6 participants
|
16 participants
|
1 participants
|
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 |
Treatment-naive Female Patients
n=45 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=36 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=51 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=45 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=12 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Viral Load After 36 Months From Baseline
|
-2.7 Log10 copies/mL
Standard Deviation 1.2
|
-2.7 Log10 copies/mL
Standard Deviation 1.5
|
-0.3 Log10 copies/mL
Standard Deviation 0.7
|
-0.3 Log10 copies/mL
Standard Deviation 0.5
|
-2.4 Log10 copies/mL
Standard Deviation 1.7
|
-1.2 Log10 copies/mL
Standard Deviation 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from FAS with values for CD4+ at baseline and after 36 months.
The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
Outcome measures
| Measure |
Treatment-naive Female Patients
n=44 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=35 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=50 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=45 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=30 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=12 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=1 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
n=1 Participants
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the CD4+ Cell Count After 36 Months From Baseline
|
253.3 cells/mm^3
Standard Deviation 209.9
|
216.9 cells/mm^3
Standard Deviation 191.4
|
85.9 cells/mm^3
Standard Deviation 196.6
|
39.8 cells/mm^3
Standard Deviation 193.6
|
246.4 cells/mm^3
Standard Deviation 271.2
|
137.1 cells/mm^3
Standard Deviation 301.8
|
115.0 cells/mm^3
|
342.0 cells/mm^3
|
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 |
Treatment-naive Female Patients
n=14 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=5 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=5 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=13 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=1 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=2 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
|
3.9 mg/dL
Standard Deviation 61.0
|
32.9 mg/dL
Standard Deviation 20.8
|
-11.5 mg/dL
Standard Deviation 60.3
|
43.0 mg/dL
Standard Deviation 37.6
|
-2.0 mg/dL
Standard Deviation 34.5
|
26.0 mg/dL
Standard Deviation NA
N=1
|
74.0 mg/dL
Standard Deviation 32.5
|
—
|
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 |
Treatment-naive Female Patients
n=7 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=3 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=6 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=5 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=6 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=2 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
|
15.6 mg/dL
Standard Deviation 15.5
|
20.2 mg/dL
Standard Deviation 1.0
|
9.3 mg/dL
Standard Deviation 17.1
|
-26.5 mg/dL
Standard Deviation 102.8
|
18.9 mg/dL
Standard Deviation 13.1
|
—
|
5.0 mg/dL
Standard Deviation 21.2
|
—
|
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 |
Treatment-naive Female Patients
n=7 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=3 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=6 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=5 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=6 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=2 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
|
5.3 mg/dL
Standard Deviation 30.3
|
27.8 mg/dL
Standard Deviation 13.9
|
3.8 mg/dL
Standard Deviation 24.3
|
5.0 mg/dL
Standard Deviation 30.4
|
-9.3 mg/dL
Standard Deviation 27.8
|
—
|
73.0 mg/dL
Standard Deviation 42.4
|
—
|
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 |
Treatment-naive Female Patients
n=14 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=5 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=6 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=13 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=1 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=2 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
|
-18.5 mg/dL
Standard Deviation 63.1
|
-16.6 mg/dL
Standard Deviation 32.3
|
-71.8 mg/dL
Standard Deviation 102.2
|
-31.7 mg/dL
Standard Deviation 90.8
|
-53.3 mg/dL
Standard Deviation 53.7
|
160 mg/dL
Standard Deviation NA
N=1
|
-5.5 mg/dL
Standard Deviation 50.2
|
—
|
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 |
Treatment-naive Female Patients
n=14 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=5 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=11 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=4 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=15 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=1 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
|
2.4 mg/dL
Standard Deviation 29.1
|
5.3 mg/dL
Standard Deviation 18.6
|
0.2 mg/dL
Standard Deviation 22.2
|
3.9 mg/dL
Standard Deviation 7.2
|
7.2 mg/dL
Standard Deviation 13.8
|
-27.5 mg/dL
Standard Deviation NA
N=1
|
-17.3 mg/dL
Standard Deviation 38.5
|
—
|
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 |
Treatment-naive Female Patients
n=13 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=7 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=16 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=2 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data ( ALT) After 36 Months From Baseline
|
1.3 U/L
Standard Deviation 8.6
|
7.5 U/L
Standard Deviation 13.8
|
7.7 U/L
Standard Deviation 11.7
|
6.1 U/L
Standard Deviation 18.7
|
0.0 U/L
Standard Deviation 15.4
|
12.6 U/L
Standard Deviation 34.8
|
6.3 U/L
Standard Deviation 11.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for the 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 |
Treatment-naive Female Patients
n=13 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=7 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=8 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=16 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=2 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (AST) After 36 Months From Baseline
|
1.4 U/L
Standard Deviation 9.5
|
3.0 U/L
Standard Deviation 11.2
|
1.4 U/L
Standard Deviation 5.6
|
0.4 U/L
Standard Deviation 10.3
|
-1.7 U/L
Standard Deviation 13.5
|
-0.8 U/L
Standard Deviation 17.3
|
0.7 U/L
Standard Deviation 6.1
|
—
|
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 |
Treatment-naive Female Patients
n=14 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=7 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=16 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=2 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline
|
22.7 U/L
Standard Deviation 26.9
|
25.2 U/L
Standard Deviation 15.4
|
7.0 U/L
Standard Deviation 25.7
|
4.8 U/L
Standard Deviation 111.7
|
20.9 U/L
Standard Deviation 31.6
|
40.8 U/L
Standard Deviation 61.9
|
-4.7 U/L
Standard Deviation 10.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Patients from TS with evaluable data for creatinine at baseline and at month 36.
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 |
Treatment-naive Female Patients
n=13 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=7 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=10 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=16 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=2 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
|
0.0 mg/dL
Standard Deviation 0.2
|
0.1 mg/dL
Standard Deviation 0.1
|
-0.1 mg/dL
Standard Deviation 0.2
|
-0.1 mg/dL
Standard Deviation 0.1
|
0.0 mg/dL
Standard Deviation 0.1
|
-0.1 mg/dL
Standard Deviation 0.0
|
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 |
Treatment-naive Female Patients
n=14 Participants
Female patients who were not pretreated with HIV therapy.
|
Treatment-naive Male Patients
n=7 Participants
Male patients who were not pretreated with HIV therapy.
|
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL
n=9 Participants
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
|
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL
n=16 Participants
Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL
n=2 Participants
Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Female Patients, Baseline Viral Load Not Documented
n=3 Participants
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
Male Patients, Baseline Viral Load Not Documented
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
|
0.8 g/dL
Standard Deviation 1.3
|
0.4 g/dL
Standard Deviation 0.8
|
0.1 g/dL
Standard Deviation 1.1
|
0.8 g/dL
Standard Deviation 1.0
|
1.1 g/dL
Standard Deviation 1.1
|
1.0 g/dL
Standard Deviation 2.4
|
0.3 g/dL
Standard Deviation 1.8
|
—
|
Adverse Events
Treatment-naive Patients
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
Pretreated Patients, Baseline Viral Load > 50 Copies/mL
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Patients With Baseline Viral Load Not Documented
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-naive Patients
n=101 participants at risk
Female and male patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=97 participants at risk
Female and male 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 at risk
Female and male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=20 participants at risk
Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
General disorders
Local swelling
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
General disorders
Swelling
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Hepatobiliary disorders
Jaundice
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Psychiatric disorders
Completed suicide
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Psychiatric disorders
Depression
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Psychiatric disorders
Mental disorder
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.99%
1/101 • 36 months
|
0.00%
0/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/101 • 36 months
|
0.00%
0/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/101 • 36 months
|
1.0%
1/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
Other adverse events
| Measure |
Treatment-naive Patients
n=101 participants at risk
Female and male patients who were not pretreated with HIV therapy.
|
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL
n=97 participants at risk
Female and male 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 at risk
Female and male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.
|
Patients With Baseline Viral Load Not Documented
n=20 participants at risk
Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.99%
1/101 • 36 months
|
1.0%
1/97 • 36 months
|
6.4%
3/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
7/101 • 36 months
|
2.1%
2/97 • 36 months
|
0.00%
0/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.9%
11/101 • 36 months
|
11.3%
11/97 • 36 months
|
6.4%
3/47 • 36 months
|
10.0%
2/20 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
10.9%
11/101 • 36 months
|
7.2%
7/97 • 36 months
|
6.4%
3/47 • 36 months
|
10.0%
2/20 • 36 months
|
|
General disorders
Asthenia
|
3.0%
3/101 • 36 months
|
6.2%
6/97 • 36 months
|
4.3%
2/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
General disorders
Fatigue
|
8.9%
9/101 • 36 months
|
9.3%
9/97 • 36 months
|
4.3%
2/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Bronchitis
|
9.9%
10/101 • 36 months
|
13.4%
13/97 • 36 months
|
10.6%
5/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Gastroenteritis
|
2.0%
2/101 • 36 months
|
3.1%
3/97 • 36 months
|
8.5%
4/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Herpes zoster
|
4.0%
4/101 • 36 months
|
1.0%
1/97 • 36 months
|
6.4%
3/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Infection
|
5.0%
5/101 • 36 months
|
7.2%
7/97 • 36 months
|
4.3%
2/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/101 • 36 months
|
6.2%
6/97 • 36 months
|
8.5%
4/47 • 36 months
|
10.0%
2/20 • 36 months
|
|
Infections and infestations
Sinusitis
|
3.0%
3/101 • 36 months
|
4.1%
4/97 • 36 months
|
6.4%
3/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
12/101 • 36 months
|
12.4%
12/97 • 36 months
|
17.0%
8/47 • 36 months
|
15.0%
3/20 • 36 months
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/101 • 36 months
|
6.2%
6/97 • 36 months
|
0.00%
0/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Investigations
Alanine aminotransferase increased
|
0.99%
1/101 • 36 months
|
6.2%
6/97 • 36 months
|
4.3%
2/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Investigations
Blood cholesterol increased
|
5.0%
5/101 • 36 months
|
6.2%
6/97 • 36 months
|
4.3%
2/47 • 36 months
|
15.0%
3/20 • 36 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.9%
8/101 • 36 months
|
16.5%
16/97 • 36 months
|
12.8%
6/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Investigations
Low density lipoprotein increased
|
4.0%
4/101 • 36 months
|
5.2%
5/97 • 36 months
|
4.3%
2/47 • 36 months
|
10.0%
2/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
6/101 • 36 months
|
8.2%
8/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
5/101 • 36 months
|
8.2%
8/97 • 36 months
|
0.00%
0/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/101 • 36 months
|
6.2%
6/97 • 36 months
|
0.00%
0/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Nervous system disorders
Dizziness
|
4.0%
4/101 • 36 months
|
5.2%
5/97 • 36 months
|
2.1%
1/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Nervous system disorders
Headache
|
6.9%
7/101 • 36 months
|
11.3%
11/97 • 36 months
|
8.5%
4/47 • 36 months
|
15.0%
3/20 • 36 months
|
|
Psychiatric disorders
Depression
|
3.0%
3/101 • 36 months
|
15.5%
15/97 • 36 months
|
6.4%
3/47 • 36 months
|
5.0%
1/20 • 36 months
|
|
Psychiatric disorders
Sleep disorder
|
3.0%
3/101 • 36 months
|
5.2%
5/97 • 36 months
|
0.00%
0/47 • 36 months
|
0.00%
0/20 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/101 • 36 months
|
8.2%
8/97 • 36 months
|
4.3%
2/47 • 36 months
|
10.0%
2/20 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
4/101 • 36 months
|
3.1%
3/97 • 36 months
|
6.4%
3/47 • 36 months
|
5.0%
1/20 • 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