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Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

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ClinicalTrials.gov Identifier: NCT00517192
Recruitment Status : Terminated
First Posted : August 16, 2007
Results First Posted : October 23, 2009
Last Update Posted : May 14, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Tipranavir
Drug: Darunavir
Drug: Ritonavir
Enrollment 40

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Period Title: Overall Study
Started 19 20
Completed 0 0
Not Completed 19 20
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             1             1
Withdrawal by Subject             1             0
Early termination of the trial             16             18
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg Total
Hide Arm/Group Description Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
44.3  (6.1) 43.1  (6.2) 43.6  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
4
  21.1%
3
  15.0%
7
  17.9%
Male
15
  78.9%
17
  85.0%
32
  82.1%
1.Primary Outcome
Title Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.
Hide Description [Not Specified]
Time Frame 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).
Hide Description [Not Specified]
Time Frame 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.
Hide Description [Not Specified]
Time Frame 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.
Hide Description [Not Specified]
Time Frame 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat
Hide Description [Not Specified]
Time Frame up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8
Hide Description [Not Specified]
Time Frame up to week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Daily Average in CD4+ Cell Count Change From Baseline up to Week 24
Hide Description [Not Specified]
Time Frame up to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Daily Average in CD4+ Cell Count Change From Baseline up to Week 48
Hide Description [Not Specified]
Time Frame up to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Daily Average in Viral Load Change From Baseline up to Week 8
Hide Description [Not Specified]
Time Frame up to week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Daily Average in Viral Load Change From Baseline up to Week 24
Hide Description [Not Specified]
Time Frame up to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Daily Average in Viral Load Change From Baseline up to Week 48
Hide Description [Not Specified]
Time Frame up to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count up to Week 48
Hide Description [Not Specified]
Time Frame up to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Change From Baseline in log10 Viral Load up to Week 48
Hide Description [Not Specified]
Time Frame up to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Occurrence of New AIDS Progression Events or Death
Hide Description [Not Specified]
Time Frame through 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description:
Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the signing of the informed consent onwards through the observational phase (50 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Hide Arm/Group Description Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
All-Cause Mortality
Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   2/20 (10.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  0/19 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Gangrene  1  0/19 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Spondylolisthesis  1  0/19 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Peroneal nerve palsy  1  0/19 (0.00%)  1/20 (5.00%) 
Radiculopathy  1  0/19 (0.00%)  1/20 (5.00%) 
Vascular disorders     
Iliac artery thrombosis  1  0/19 (0.00%)  1/20 (5.00%) 
Peripheral ischaemia  1  0/19 (0.00%)  1/20 (5.00%) 
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%
Tipranavir 500 mg/Ritonavir 200 mg Darunavir 600 mg/Ritonavir 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   12/19 (63.16%)   7/20 (35.00%) 
Cardiac disorders     
Angina pectoris  1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/19 (5.26%)  0/20 (0.00%) 
Abdominal pain  1  1/19 (5.26%)  0/20 (0.00%) 
Diarrhoea  1  3/19 (15.79%)  3/20 (15.00%) 
Nausea  1  1/19 (5.26%)  1/20 (5.00%) 
Odynophagia  1  1/19 (5.26%)  0/20 (0.00%) 
Vomiting  1  1/19 (5.26%)  1/20 (5.00%) 
General disorders     
Asthenia  1  2/19 (10.53%)  0/20 (0.00%) 
Fatigue  1  2/19 (10.53%)  0/20 (0.00%) 
Pyrexia  1  0/19 (0.00%)  2/20 (10.00%) 
Hepatobiliary disorders     
Cytolytic hepatitis  1  1/19 (5.26%)  0/20 (0.00%) 
Infections and infestations     
Bronchitis  1  2/19 (10.53%)  0/20 (0.00%) 
Subcutaneous abscess  1  1/19 (5.26%)  0/20 (0.00%) 
Tracheitis  1  1/19 (5.26%)  0/20 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  1  1/19 (5.26%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/19 (5.26%)  0/20 (0.00%) 
Myalgia  1  1/19 (5.26%)  1/20 (5.00%) 
Osteoarthritis  1  1/19 (5.26%)  0/20 (0.00%) 
Nervous system disorders     
Dizziness  1  1/19 (5.26%)  0/20 (0.00%) 
Headache  1  1/19 (5.26%)  3/20 (15.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/19 (10.53%)  1/20 (5.00%) 
Productive cough  1  1/19 (5.26%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Facial wasting  1  1/19 (5.26%)  0/20 (0.00%) 
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 Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00517192     History of Changes
Other Study ID Numbers: 1182.71
First Submitted: August 15, 2007
First Posted: August 16, 2007
Results First Submitted: September 18, 2009
Results First Posted: October 23, 2009
Last Update Posted: May 14, 2014