Trial Outcomes & Findings for Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients. (NCT NCT00531206)
NCT ID: NCT00531206
Last Updated: 2014-04-07
Results Overview
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Recruitment status
COMPLETED
Target enrollment
65 participants
Primary outcome timeframe
52 weeks
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
Aptivus® in Combination With Low-dose Norvir®
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Aptivus® in Combination With Low-dose Norvir®
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Overall Study
Adverse Event related
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
including non-related adverse events
|
8
|
Baseline Characteristics
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
Baseline characteristics by cohort
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Adverse Events
|
23 Number of patients with adverse events
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Log10 change from baseline in viral load over time
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Change in Viral Load
change from baseline to month 1 (4 weeks)
|
-1.56 log10 copies/ml
Interval -1.94 to -0.54
|
|
Change in Viral Load
change from baseline to month 3 (12 weeks)
|
-1.70 log10 copies/ml
Interval -2.47 to -0.48
|
|
Change in Viral Load
change from baseline to month 6 (24 weeks)
|
-1.42 log10 copies/ml
Interval -2.59 to -0.45
|
|
Change in Viral Load
change from baseline to month 9 (36 weeks)
|
-1.42 log10 copies/ml
Interval -2.94 to -0.71
|
|
Change in Viral Load
change from baseline to month 12 (52 weeks)
|
-1.45 log10 copies/ml
Interval -2.42 to -0.54
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Change from baseline in CD4+ count over time
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
CD4+ Cell Count
change from baseline to month 1 (4 weeks)
|
30.50 cells/mm3
Interval -17.0 to 85.5
|
|
CD4+ Cell Count
change from baseline to month 3 (12 weeks)
|
43.50 cells/mm3
Interval -4.5 to 144.5
|
|
CD4+ Cell Count
change from baseline to month 6 (24 weeks)
|
39.50 cells/mm3
Interval 0.0 to 144.0
|
|
CD4+ Cell Count
change from baseline to month 9 (36 weeks)
|
63.00 cells/mm3
Interval 13.0 to 155.0
|
|
CD4+ Cell Count
change from baseline to month 12 (52 weeks)
|
36.00 cells/mm3
Interval -5.0 to 191.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Investigator's opinion of patient's general condition (quality of life)
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Subjective Well-being
good general condition
|
23 participants
|
|
Subjective Well-being
moderate general condition
|
35 participants
|
|
Subjective Well-being
bad general condition
|
7 participants
|
|
Subjective Well-being
missing
|
0 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Serious Adverse Events
|
3 Number of patients
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Deaths
|
1 Number of patients
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Discontinuations Due to an Adverse Event
|
6 Number of patients
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion
|
7 Number of patients
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
< 6
|
30 participants
|
|
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
6 - 10
|
15 participants
|
|
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
11 - 15
|
16 participants
|
|
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
> 15
|
3 participants
|
|
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
missing
|
1 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Use of Lipid Lowering Agents During the Study
No
|
59 participants
|
|
Use of Lipid Lowering Agents During the Study
Yes
|
6 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Body Mass Index Class (Kilograms/Square Meter)
Low (< 18)
|
2 participants
|
|
Body Mass Index Class (Kilograms/Square Meter)
Normal (18 - 30)
|
62 participants
|
|
Body Mass Index Class (Kilograms/Square Meter)
High (> 30)
|
0 participants
|
|
Body Mass Index Class (Kilograms/Square Meter)
missing
|
1 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Total Cholesterol Over Time
Month 6 (n=48)
|
213.0 mg/dl
Interval 189.3 to 240.0
|
|
Total Cholesterol Over Time
Month 9 (n=37)
|
217.0 mg/dl
Interval 177.0 to 235.0
|
|
Total Cholesterol Over Time
Month 12 (n=35)
|
216.0 mg/dl
Interval 177.9 to 232.0
|
|
Total Cholesterol Over Time
Month 1 (n=42)
|
213.0 mg/dl
Interval 179.0 to 233.0
|
|
Total Cholesterol Over Time
Month 3 (n=41)
|
214.0 mg/dl
Interval 175.0 to 229.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
High Density Lipoprotein (HDL) Cholesterol Over Time
Month 1 (n=28)
|
38.0 mg/dl
Interval 35.5 to 47.0
|
|
High Density Lipoprotein (HDL) Cholesterol Over Time
Month 3 (n=29)
|
39.0 mg/dl
Interval 35.0 to 45.0
|
|
High Density Lipoprotein (HDL) Cholesterol Over Time
Month 6 (n=32)
|
39.5 mg/dl
Interval 34.6 to 47.0
|
|
High Density Lipoprotein (HDL) Cholesterol Over Time
Month 9 (n=28)
|
39.0 mg/dl
Interval 33.5 to 48.0
|
|
High Density Lipoprotein (HDL) Cholesterol Over Time
Month 12 (n=27)
|
37.0 mg/dl
Interval 33.0 to 53.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Low Density Lipoprotein (HDL) Cholesterol Over Time
Month 1 (n=23)
|
120.0 mg/dl
Interval 88.0 to 147.0
|
|
Low Density Lipoprotein (HDL) Cholesterol Over Time
Month 3 (n=25)
|
123.0 mg/dl
Interval 99.0 to 134.0
|
|
Low Density Lipoprotein (HDL) Cholesterol Over Time
Month 6 (n=29)
|
125.0 mg/dl
Interval 110.0 to 147.0
|
|
Low Density Lipoprotein (HDL) Cholesterol Over Time
Month 9 (n=26)
|
117.5 mg/dl
Interval 98.0 to 132.0
|
|
Low Density Lipoprotein (HDL) Cholesterol Over Time
Month 12 (n=23)
|
122.0 mg/dl
Interval 102.0 to 138.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Triglycerides Over Time
Month 1 (n=38)
|
237.5 mg/dl
Interval 143.0 to 479.0
|
|
Triglycerides Over Time
Month 3 (n=39)
|
256.9 mg/dl
Interval 160.0 to 361.0
|
|
Triglycerides Over Time
Month 9 (n=33)
|
283.4 mg/dl
Interval 186.0 to 330.0
|
|
Triglycerides Over Time
Month 12 (n=32)
|
265.5 mg/dl
Interval 171.0 to 458.5
|
|
Triglycerides Over Time
Month 6 (n=46)
|
246.0 mg/dl
Interval 190.0 to 361.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Alanine Aminotransferase (ALT) Over Time
Month 1 (n=52)
|
33.0 international units/liter
Interval 25.7 to 48.5
|
|
Alanine Aminotransferase (ALT) Over Time
Month 3 (n=49)
|
31.0 international units/liter
Interval 24.0 to 50.0
|
|
Alanine Aminotransferase (ALT) Over Time
Month 6 (n=55)
|
37.0 international units/liter
Interval 27.0 to 51.0
|
|
Alanine Aminotransferase (ALT) Over Time
Month 9 (n=41)
|
34.0 international units/liter
Interval 28.0 to 53.0
|
|
Alanine Aminotransferase (ALT) Over Time
Month 12 (n=42)
|
37.5 international units/liter
Interval 29.0 to 54.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Aspartate Aminotransferase (ALT) Over Time
Month 1 (n=54)
|
34.5 international units/liter
Interval 25.0 to 55.0
|
|
Aspartate Aminotransferase (ALT) Over Time
Month 3 (n=50)
|
33.5 international units/liter
Interval 23.0 to 55.0
|
|
Aspartate Aminotransferase (ALT) Over Time
Month 6 (n=57)
|
40.0 international units/liter
Interval 25.0 to 62.0
|
|
Aspartate Aminotransferase (ALT) Over Time
Month 9 (n=44)
|
44.0 international units/liter
Interval 27.0 to 62.0
|
|
Aspartate Aminotransferase (ALT) Over Time
Month 12 (n=42)
|
37.5 international units/liter
Interval 29.0 to 53.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Gamma-glutamyl Transpeptidase (GGT) Over Time
Month 1 (n=54)
|
72.0 international units/liter
Interval 41.0 to 121.0
|
|
Gamma-glutamyl Transpeptidase (GGT) Over Time
Month 3 (n=49)
|
72.0 international units/liter
Interval 50.0 to 164.0
|
|
Gamma-glutamyl Transpeptidase (GGT) Over Time
Month 6 (n=57)
|
72.0 international units/liter
Interval 56.0 to 154.0
|
|
Gamma-glutamyl Transpeptidase (GGT) Over Time
Month 9 (n=44)
|
76.0 international units/liter
Interval 48.0 to 128.0
|
|
Gamma-glutamyl Transpeptidase (GGT) Over Time
Month 12 (n=43)
|
68.0 international units/liter
Interval 50.0 to 104.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Creatinine Over Time
Month 1 (n=43)
|
0.90 mg/dl
Interval 0.8 to 1.0
|
|
Creatinine Over Time
Month 3 (n=46)
|
0.90 mg/dl
Interval 0.8 to 1.01
|
|
Creatinine Over Time
Month 6 (n=49)
|
0.90 mg/dl
Interval 0.8 to 1.0
|
|
Creatinine Over Time
Month 9 (n=35)
|
0.90 mg/dl
Interval 0.8 to 1.07
|
|
Creatinine Over Time
Month 12 (n=33)
|
0.90 mg/dl
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Total Bilirubin Over Time
Month 1 (n=39)
|
0.42 mg/dl
Interval 0.34 to 0.6
|
|
Total Bilirubin Over Time
Month 3 (n=38)
|
0.40 mg/dl
Interval 0.33 to 0.6
|
|
Total Bilirubin Over Time
Month 6 (n=43)
|
0.50 mg/dl
Interval 0.38 to 0.6
|
|
Total Bilirubin Over Time
Month 9 (n=31)
|
0.50 mg/dl
Interval 0.4 to 0.6
|
|
Total Bilirubin Over Time
Month 12 (n=32)
|
0.40 mg/dl
Interval 0.36 to 0.51
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set (FAS), all patients entered and treated
Outcome measures
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 Participants
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Alkaline Phosphatase Over Time
Month 1 (n=33)
|
90.0 international units/liter
Interval 76.0 to 111.0
|
|
Alkaline Phosphatase Over Time
Month 3 (n=38)
|
92.5 international units/liter
Interval 76.0 to 103.5
|
|
Alkaline Phosphatase Over Time
Month 12 (n=43)
|
92.5 international units/liter
Interval 76.2 to 108.5
|
|
Alkaline Phosphatase Over Time
Month 6 (n=26)
|
87.5 international units/liter
Interval 80.0 to 114.0
|
|
Alkaline Phosphatase Over Time
Month 9 (n=24)
|
86.5 international units/liter
Interval 79.0 to 118.0
|
Adverse Events
Aptivus® in Combination With Low-dose Norvir®
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 participants at risk
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
General disorders
Death
|
1.5%
1/65 • 52 weeks
|
|
Investigations
Transaminases increased
|
1.5%
1/65 • 52 weeks
|
|
Vascular disorders
Pulmonary embolism
|
1.5%
1/65 • 52 weeks
|
Other adverse events
| Measure |
Aptivus® in Combination With Low-dose Norvir®
n=65 participants at risk
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/65 • 52 weeks
|
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 Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER