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Trial record 18 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

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ClinicalTrials.gov Identifier: NCT00530920
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : July 8, 2009
Last Update Posted : June 6, 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: ritonavir
Enrollment 85

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description Tipranavir 500 mg boosted with ritonavir 200 mg given once daily Tipranavir 250 mg boosted with ritonavir 100 mg given once daily Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Period Title: Overall Study
Started 30 27 28
Completed 30 25 24
Not Completed 0 2 4
Reason Not Completed
Randomized but not treated             0             2             0
Adverse Event             0             0             3
Withdrawal by Subject             0             0             1
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily Total
Hide Arm/Group Description Tipranavir 500 mg boosted with ritonavir 200 mg given once daily Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily Total of all reporting groups
Overall Number of Baseline Participants 30 25 28 83
Hide Baseline Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 25 participants 28 participants 83 participants
33  (7.54) 36.9  (8.04) 36.4  (8) 35.3  (7.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 25 participants 28 participants 83 participants
Female
2
   6.7%
1
   4.0%
4
  14.3%
7
   8.4%
Male
28
  93.3%
24
  96.0%
24
  85.7%
76
  91.6%
1.Primary Outcome
Title Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Hide Description [Not Specified]
Time Frame Baseline (Day 0) to Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 28
Median (Inter-Quartile Range)
Unit of Measure: Log10 copies/mL
-1.43
(-1.66 to -1.24)
-1.55
(-1.70 to -1.37)
-1.47
(-1.66 to -1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
Comments NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.43
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
Comments NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Comments NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.998
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Apparent Oral Clearance I(Cl/F) of Tipranavir
Hide Description Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu­lar models the fraction of dose absorbed cannot be estimated, therefore "clear­ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
1.45
(26.79%)
1.43
(26.77%)
1.57
(35.40%)
3.Secondary Outcome
Title Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Hide Description Tipranavir (TPV) pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 29 25 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*uM
571.3
(27.3%)
289.3
(26.8%)
538.2
(36.4%)
4.Secondary Outcome
Title Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
Hide Description TPV pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 29 25 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: uM
3.26
(92.4%)
10.27
(49.4%)
17.75
(71.7%)
5.Secondary Outcome
Title Trough Concentration (Cmin) of Tipranavir
Hide Description TPV pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 29 25 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: uM
2.8
(106.8%)
12.73
(53.1%)
21.26
(86.8%)
6.Secondary Outcome
Title Maximum Concentration (Cmax) of Tipranavir
Hide Description TPV pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 29 25 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: uM
54.64
(20.2%)
36.98
(19.9%)
69.66
(26.5%)
7.Secondary Outcome
Title Volume of Distribution (V/F) of Tipranavir
Hide Description Tipranavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
10.02
(14.33%)
9.33
(9.17%)
9.39
(12.34%)
8.Secondary Outcome
Title Terminal Half-Life (t1/2) of Tipranavir
Hide Description Tipranavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
4.79
(26.3%)
4.51
(22.4%)
4.14
(33.6%)
9.Secondary Outcome
Title Time to Cmax (Tmax) of Tipranavir
Hide Description Tipranavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
3.07
(14.7%)
2.34
(15.2%)
2.38
(16.6%)
10.Secondary Outcome
Title AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*uM
5.05
(44.0%)
2.25
(47.0%)
1.74
(48.9%)
11.Secondary Outcome
Title Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: uM
0.005
(206.2%)
0.039
(134.0%)
0.025
(129.9%)
12.Secondary Outcome
Title Apparent Oral Clearance I(Cl/F) of Ritonavir
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
39.6
(44.0%)
44.4
(47.0%)
57.4
(48.9%)
13.Secondary Outcome
Title Volume of Distribution (V/F) of Ritonavir
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
97.5
(26.8%)
90.8
(24.7%)
88.9
(28.7%)
14.Secondary Outcome
Title Terminal Half-Life (t1/2) of Ritonavir
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
1.71
(45.5%)
1.42
(59.5%)
1.07
(56.1%)
15.Secondary Outcome
Title Tmax of Ritonavir
Hide Description Ritonavir pharmacokinetics
Time Frame Final (Day 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
2.84
(23.9%)
2.33
(24.9%)
2.05
(28.8%)
16.Secondary Outcome
Title Cmax of Ritonavir
Hide Description Ritonavir pharmacokinetics
Time Frame Visits baseline, 5, 7, 9 and 13 or 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: uM
0.632
(32.5%)
0.346
(30.7%)
0.291
(34.7%)
17.Secondary Outcome
Title Clinical Abnormal Findings in Laboratory and Physical Examination
Hide Description [Not Specified]
Time Frame Screening through the end of the study (14 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set.
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description:
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Overall Number of Participants Analyzed 30 25 24
Measure Type: Number
Unit of Measure: participants
Alanine aminotransferase (ALT) increased 0 0 1
Aspartate aminotransferase (AST) increased 0 0 1
Time Frame 14 days, from first treatment until last treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Hide Arm/Group Description Tipranavir 500 mg boosted with ritonavir 200 mg given once daily Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
All-Cause Mortality
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/25 (0.00%)   1/28 (3.57%) 
Investigations       
Alanine aminotransferase increased  1  0/30 (0.00%)  0/25 (0.00%)  1/28 (3.57%) 
Aspartate aminotransferase increaset  1  0/30 (0.00%)  0/25 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/30 (56.67%)   9/25 (36.00%)   15/28 (53.57%) 
Gastrointestinal disorders       
Abdominal pain upper  1  3/30 (10.00%)  1/25 (4.00%)  1/28 (3.57%) 
Diarrhoea  1  10/30 (33.33%)  3/25 (12.00%)  11/28 (39.29%) 
Flatulence  1  0/30 (0.00%)  2/25 (8.00%)  0/28 (0.00%) 
Nausea  1  3/30 (10.00%)  1/25 (4.00%)  4/28 (14.29%) 
General disorders       
Fatigue  1  1/30 (3.33%)  3/25 (12.00%)  2/28 (7.14%) 
Nervous system disorders       
Dizziness  1  2/30 (6.67%)  1/25 (4.00%)  2/28 (7.14%) 
Dysgeusia  1  2/30 (6.67%)  0/25 (0.00%)  0/28 (0.00%) 
Headache  1  2/30 (6.67%)  2/25 (8.00%)  4/28 (14.29%) 
Psychiatric disorders       
Insomnia  1  2/30 (6.67%)  0/25 (0.00%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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: NCT00530920     History of Changes
Other Study ID Numbers: 1182.107
First Submitted: September 17, 2007
First Posted: September 18, 2007
Results First Submitted: May 15, 2009
Results First Posted: July 8, 2009
Last Update Posted: June 6, 2014