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Trial record 17 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.

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ClinicalTrials.gov Identifier: NCT00531206
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : May 12, 2010
Last Update Posted : April 7, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition HIV Infections
Interventions Drug: Tipranavir
Drug: Ritonavir
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Period Title: Overall Study
Started 65
Completed 45
Not Completed 20
Reason Not Completed
Adverse Event related             5
Lack of Efficacy             2
Lost to Follow-up             5
including non-related adverse events             8
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
45.9  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
6
   9.2%
Male
59
  90.8%
1.Primary Outcome
Title Adverse Events
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Number of patients with adverse events
23
2.Secondary Outcome
Title Change in Viral Load
Hide Description Log10 change from baseline in viral load over time
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/ml
change from baseline to month 1 (4 weeks)
-1.56
(-1.94 to -0.54)
change from baseline to month 3 (12 weeks)
-1.70
(-2.47 to -0.48)
change from baseline to month 6 (24 weeks)
-1.42
(-2.59 to -0.45)
change from baseline to month 9 (36 weeks)
-1.42
(-2.94 to -0.71)
change from baseline to month 12 (52 weeks)
-1.45
(-2.42 to -0.54)
3.Secondary Outcome
Title CD4+ Cell Count
Hide Description Change from baseline in CD4+ count over time
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
change from baseline to month 1 (4 weeks)
30.50
(-17.0 to 85.5)
change from baseline to month 3 (12 weeks)
43.50
(-4.5 to 144.5)
change from baseline to month 6 (24 weeks)
39.50
(0.0 to 144.0)
change from baseline to month 9 (36 weeks)
63.00
(13.0 to 155.0)
change from baseline to month 12 (52 weeks)
36.00
(-5.0 to 191.0)
4.Secondary Outcome
Title Subjective Well-being
Hide Description Investigator’s opinion of patient’s general condition (quality of life)
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
good general condition 23
moderate general condition 35
bad general condition 7
missing 0
5.Secondary Outcome
Title Serious Adverse Events
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Number of patients
3
6.Secondary Outcome
Title Deaths
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Number of patients
1
7.Secondary Outcome
Title Discontinuations Due to an Adverse Event
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Number of patients
6
8.Secondary Outcome
Title Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Number of patients
7
9.Secondary Outcome
Title Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
< 6 30
6 - 10 15
11 - 15 16
> 15 3
missing 1
10.Secondary Outcome
Title Use of Lipid Lowering Agents During the Study
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
No 59
Yes 6
11.Secondary Outcome
Title Body Mass Index Class (Kilograms/Square Meter)
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Low (< 18) 2
Normal (18 - 30) 62
High (> 30) 0
missing 1
12.Secondary Outcome
Title Total Cholesterol Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=42)
213.0
(179.0 to 233.0)
Month 3 (n=41)
214.0
(175.0 to 229.0)
Month 6 (n=48)
213.0
(189.3 to 240.0)
Month 9 (n=37)
217.0
(177.0 to 235.0)
Month 12 (n=35)
216.0
(177.9 to 232.0)
13.Secondary Outcome
Title High Density Lipoprotein (HDL) Cholesterol Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=28)
38.0
(35.5 to 47.0)
Month 3 (n=29)
39.0
(35.0 to 45.0)
Month 6 (n=32)
39.5
(34.6 to 47.0)
Month 9 (n=28)
39.0
(33.5 to 48.0)
Month 12 (n=27)
37.0
(33.0 to 53.0)
14.Secondary Outcome
Title Low Density Lipoprotein (HDL) Cholesterol Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=23)
120.0
(88.0 to 147.0)
Month 3 (n=25)
123.0
(99.0 to 134.0)
Month 6 (n=29)
125.0
(110.0 to 147.0)
Month 9 (n=26)
117.5
(98.0 to 132.0)
Month 12 (n=23)
122.0
(102.0 to 138.0)
15.Secondary Outcome
Title Triglycerides Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=38)
237.5
(143.0 to 479.0)
Month 3 (n=39)
256.9
(160.0 to 361.0)
Month 6 (n=46)
246.0
(190.0 to 361.0)
Month 9 (n=33)
283.4
(186.0 to 330.0)
Month 12 (n=32)
265.5
(171.0 to 458.5)
16.Secondary Outcome
Title Alanine Aminotransferase (ALT) Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: international units/liter
Month 1 (n=52)
33.0
(25.7 to 48.5)
Month 3 (n=49)
31.0
(24.0 to 50.0)
Month 6 (n=55)
37.0
(27.0 to 51.0)
Month 9 (n=41)
34.0
(28.0 to 53.0)
Month 12 (n=42)
37.5
(29.0 to 54.0)
17.Secondary Outcome
Title Aspartate Aminotransferase (ALT) Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: international units/liter
Month 1 (n=54)
34.5
(25.0 to 55.0)
Month 3 (n=50)
33.5
(23.0 to 55.0)
Month 6 (n=57)
40.0
(25.0 to 62.0)
Month 9 (n=44)
44.0
(27.0 to 62.0)
Month 12 (n=42)
37.5
(29.0 to 53.0)
18.Secondary Outcome
Title Gamma-glutamyl Transpeptidase (GGT) Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: international units/liter
Month 1 (n=54)
72.0
(41.0 to 121.0)
Month 3 (n=49)
72.0
(50.0 to 164.0)
Month 6 (n=57)
72.0
(56.0 to 154.0)
Month 9 (n=44)
76.0
(48.0 to 128.0)
Month 12 (n=43)
68.0
(50.0 to 104.0)
19.Secondary Outcome
Title Creatinine Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=43)
0.90
(0.80 to 1.00)
Month 3 (n=46)
0.90
(0.80 to 1.01)
Month 6 (n=49)
0.90
(0.80 to 1.00)
Month 9 (n=35)
0.90
(0.80 to 1.07)
Month 12 (n=33)
0.90
(0.80 to 1.00)
20.Secondary Outcome
Title Total Bilirubin Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Month 1 (n=39)
0.42
(0.34 to 0.60)
Month 3 (n=38)
0.40
(0.33 to 0.60)
Month 6 (n=43)
0.50
(0.38 to 0.60)
Month 9 (n=31)
0.50
(0.40 to 0.60)
Month 12 (n=32)
0.40
(0.36 to 0.51)
21.Secondary Outcome
Title Alkaline Phosphatase Over Time
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all patients entered and treated
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description:
Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
Overall Number of Participants Analyzed 65
Median (Inter-Quartile Range)
Unit of Measure: international units/liter
Month 1 (n=33)
90.0
(76.0 to 111.0)
Month 3 (n=38)
92.5
(76.0 to 103.5)
Month 6 (n=26)
87.5
(80.0 to 114.0)
Month 9 (n=24)
86.5
(79.0 to 118.0)
Month 12 (n=43)
92.5
(76.2 to 108.5)
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aptivus® in Combination With Low-dose Norvir®
Hide Arm/Group Description Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
All-Cause Mortality
Aptivus® in Combination With Low-dose Norvir®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aptivus® in Combination With Low-dose Norvir®
Affected / at Risk (%)
Total   3/65 (4.62%) 
General disorders   
Death  1  1/65 (1.54%) 
Investigations   
Transaminases increased  1  1/65 (1.54%) 
Vascular disorders   
Pulmonary embolism  1  1/65 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aptivus® in Combination With Low-dose Norvir®
Affected / at Risk (%)
Total   4/65 (6.15%) 
Gastrointestinal disorders   
Nausea  1  4/65 (6.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00531206     History of Changes
Other Study ID Numbers: 1182.112
First Submitted: September 17, 2007
First Posted: September 18, 2007
Results First Submitted: January 28, 2010
Results First Posted: May 12, 2010
Last Update Posted: April 7, 2014