Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00054717
• Collaborator: (none)
• Enrollment: 630
• Locations: 117
• Arms: 2
• Patients Per Site: 5.4

Study Details

Study Description

Brief Summary

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tipranavir; Drug: Ritonavir(r); Drug: Comparator Protease Inhibitor (CPI)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 630 participants
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Tipranavir(TPV)/low dose ritonavir(r)	Drug: Tipranavir; Drug: Ritonavir(r)
Other: Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Drug: Ritonavir(r); Drug: Comparator Protease Inhibitor (CPI)

Outcome Measures

Primary Outcome Measures

1. Treatment Response at Week 48 [At week 48]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

2. Time to Treatment Failure Through 48 Weeks of Treatment [Week 48]

   Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.

Secondary Outcome Measures

1. Treatment Response at Week 24 [Week 24]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

2. Treatment Response at Week 2 [week 2]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

3. Treatment Response at Week 4 [week 4]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

4. Treatment Response at Week 8 [week 8]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

5. Treatment Response at Week 16 [week 16]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

6. Treatment Response at Week 32 [Week 32]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

7. Treatment Response at Week 40 [Week 40]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

8. Treatment Response at Week 48 [Week 48]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

9. Treatment Response at Week 56 [week 56]

   Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

10. Treatment Response at Week 64 [week 64]

    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

11. Treatment Response at Week 72 [Week 72]

    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

12. Treatment Response at Week 80 [Week 80]

    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

13. Treatment Response at Week 88 [Week 88]

    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

14. Treatment Response at Week 96 [Week 96]

    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

15. Time to Treatment Failure Through 96 Weeks of Treatment [Week 96]

    time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.

16. Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [Week 48]

    Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.

17. Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [Week 96]

    Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.

18. Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF [Week 2 through Week 96 (at any point during trial)]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

19. Virologic Response (Viral Load >= 1 Log Drop) at Week 2 [Week 2]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

20. Virologic Response (Viral Load >= 1 Log Drop) at Week 4 [Week 4]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

21. Virologic Response (Viral Load >= 1 Log Drop) at Week 8 [Week 8]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

22. Virologic Response (Viral Load >= 1 Log Drop) at Week 16 [Week 16]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

23. Virologic Response (Viral Load >= 1 Log Drop) at Week 24 [Week 24]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

24. Virologic Response (Viral Load >= 1 Log Drop) at Week 32 [Week 32]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

25. Virologic Response (Viral Load >= 1 Log Drop) at Week 40 [Week 40]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

26. Virologic Response (Viral Load >= 1 Log Drop) at Week 48 [Week 48]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

27. Virologic Response (Viral Load >= 1 Log Drop) at Week 56 [Week 56]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

28. Virologic Response (Viral Load >= 1 Log Drop) at Week 64 [Week 64]

    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

29. Median Change From Baseline in Viral Load to Week 2 [Baseline to Week 2]

30. Median Change From Baseline in Viral Load to Week 4 [Baseline to Week 4]

31. Median Change From Baseline in Viral Load to Week 8 [Baseline to Week 8]

32. Median Change From Baseline in Viral Load to Week 16 [Baseline to Week 16]

33. Median Change From Baseline in Viral Load to Week 24 [Baseline to Week 24]

34. Median Change From Baseline in Viral Load to Week 32 [Baseline to Week 32]

35. Median Change From Baseline in Viral Load to Week 40 [Baseline to Week 40]

36. Median Change From Baseline in Viral Load to Week 48 [Baseline to Week 48]

37. Median Change From Baseline in Viral Load to Week 56 [Baseline to Week 56]

38. Median Change From Baseline in Viral Load to Week 64 [Baseline to Week 64]

39. Median Change From Baseline in Viral Load to Week 72 [Baseline to Week 72]

40. Median Change From Baseline in Viral Load to Week 80 [Baseline to Week 80]

41. Median Change From Baseline in Viral Load to Week 88 [Baseline to Week 88]

42. Median Change From Baseline in Viral Load to Week 96 [Baseline to Week 96]

43. Mean Change From Baseline to Week 2 in CD4+ Cell Count [Baseline to Week 2]

44. Mean Change From Baseline to Week 4 in CD4+ Cell Count [Baseline to Week 4]

45. Mean Change From Baseline to Week 8 in CD4+ Cell Count [Baseline to Week 8]

46. Mean Change From Baseline to Week 16 in CD4+ Cell Count [Baseline to Week 16]

47. Mean Change From Baseline to Week 24 in CD4+ Cell Count [Baseline to Week 24]

48. Mean Change From Baseline to Week 32 in CD4+ Cell Count [Baseline to Week 32]

49. Mean Change From Baseline to Week 40 in CD4+ Cell Count [Baseline to Week 40]

50. Mean Change From Baseline to Week 48 in CD4+ Cell Count [Baseline to Week 48]

51. Mean Change From Baseline to Week 56 in CD4+ Cell Count [Baseline to Week 56]

52. Mean Change From Baseline to Week 64 in CD4+ Cell Count [Baseline to Week 64]

53. Mean Change From Baseline to Week 72 in CD4+ Cell Count [Baseline to Week 72]

54. Mean Change From Baseline to Week 80 in CD4+ Cell Count [Baseline to Week 80]

55. Mean Change From Baseline to Week 88 in CD4+ Cell Count [Baseline to Week 88]

56. Mean Change From Baseline to Week 96 in CD4+ Cell Count [Baseline to Week 96]

57. Time to New CDC Class C Progression Event or Death. [after 48 weeks of treatment]

    Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death

58. Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF [Week 2 through Week 96 (at any point during trial)]

    Percentage of participants with Viral Load < 400 copies/mL

59. Virologic Response (VL < 400 Copies/ml) at Week 2 [Week 2]

    Percentage of participants with Viral Load < 400 copies/mL

60. Virologic Response (VL < 400 Copies/ml) at Week 4 [Week 4]

    Percentage of participants with Viral Load < 400 copies/mL

61. Virologic Response (VL < 400 Copies/ml) at Week 8 [Week 8]

    Percentage of participants with Viral Load < 400 copies/mL

62. Virologic Response (VL < 400 Copies/ml) at Week 16 [Week 16]

    Percentage of participants with Viral Load < 400 copies/mL

63. Virologic Response (VL < 400 Copies/ml) at Week 24 [Week 24]

    Percentage of participants with Viral Load < 400 copies/mL

64. Virologic Response (VL < 400 Copies/ml) at Week 32 [week 32]

    Percentage of participants with Viral Load < 400 copies/mL

65. Virologic Response (VL < 400 Copies/ml) at Week 40 [Week 40]

    Percentage of participants with Viral Load < 400 copies/mL

66. Virologic Response (VL < 400 Copies/ml) at Week 48 [Week 48]

    Percentage of participants with Viral Load < 400 copies/mL

67. Virologic Response (VL < 400 Copies/ml) at Week 56 [Week 56]

    Percentage of participants with Viral Load < 400 copies/mL

68. Virologic Response (VL < 400 Copies/ml) at Week 64 [Week 64]

    Percentage of participants with Viral Load < 400 copies/mL

69. Virologic Response (VL < 400 Copies/ml) at Week 72 [Week 72]

    Percentage of participants with Viral Load < 400 copies/mL

70. Virologic Response (VL < 400 Copies/ml) at Week 80 [Week 80]

    Percentage of participants with Viral Load < 400 copies/mL

71. Virologic Response (VL < 400 Copies/ml) at Week 88 [week 88]

    Percentage of participants with Viral Load < 400 copies/mL

72. Virologic Response (VL < 400 Copies/ml) at Week 96 [week 96]

    Percentage of participants with Viral Load < 400 copies/mL

73. Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF [Week 2 through Week 96 (at any point during trial)]

    Percentage of participants with Viral Load < 50 copies/mL

74. Virologic Response (VL < 50 Copies/ml) at Week 2 [Week 2]

    Percentage of participants with Viral Load < 50 copies/mL

75. Virologic Response (VL < 50 Copies/ml) at Week 4 [Week 4]

    Percentage of participants with Viral Load < 50 copies/mL

76. Virologic Response (VL < 50 Copies/ml) at Week 8 [Week 8]

    Percentage of participants with Viral Load < 50 copies/mL

77. Virologic Response (VL < 50 Copies/ml) at Week 16 [Week 16]

    Percentage of participants with Viral Load < 50 copies/mL

78. Virologic Response (VL < 50 Copies/ml) at Week 24 [Week 24]

    Percentage of participants with Viral Load < 50 copies/mL

79. Virologic Response (VL < 50 Copies/ml) at Week 32 [Week 32]

    Percentage of participants with Viral Load < 50 copies/mL

80. Virologic Response (VL < 50 Copies/ml) at Week 40 [Week 40]

    Percentage of participants with Viral Load < 50 copies/mL

81. Virologic Response (VL < 50 Copies/ml) at Week 48 [Week 48]

    Percentage of participants with Viral Load < 50 copies/mL

82. Virologic Response (VL < 50 Copies/ml) at Week 56 [Week 56]

    Percentage of participants with Viral Load < 50 copies/mL

83. Virologic Response (VL < 50 Copies/ml) at Week 64 [Week 64]

    Percentage of participants with Viral Load < 50 copies/mL

84. Virologic Response (VL < 50 Copies/ml) at Week 72 [Week 72]

    Percentage of participants with Viral Load < 50 copies/mL

85. Virologic Response (VL < 50 Copies/ml) at Week 80 [Week 80]

    Percentage of participants with Viral Load < 50 copies/mL

86. Virologic Response (VL < 50 Copies/ml) at Week 88 [Week 88]

    Percentage of participants with Viral Load < 50 copies/mL

87. Virologic Response (VL < 50 Copies/ml) at Week 96 [Week 96]

    Percentage of participants with Viral Load < 50 copies/mL

88. Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities [240 Weeks]

    NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients meeting the following criteria will be eligible for participation in th is study:

1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.

2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:

30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.

1. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.

2. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

Exclusion criteria:

Patients with any of the following criteria are excluded from participation in t he study:

1. Antiretroviral (ARV) medication naïve.

2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.

3. alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1182.12.62 Boehringer Ingelheim Investigational Site	Phoenix	Arizona	United States
2	1182.12.108 El Rio SIA	Tucson	Arizona	United States
3	1182.12.9 Boehringer Ingelheim Investigational Site	Berkeley	California	United States
4	1182.12.23 Boehringer Ingelheim Investigational Site	Beverly Hills	California	United States
5	1182.12.12 Boehringer Ingelheim Investigational Site	Fountain Valley	California	United States
6	1182.12.76 Boehringer Ingelheim Investigational Site	Long Beach	California	United States
7	1182.12.1 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
8	1182.12.59 David Geffen School of Medicine at UCLA	Los Angeles	California	United States
9	1182.12.82 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
10	1182.12.97 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
11	1182.12.69 UC Davis Medical Center	Sacramento	California	United States
12	1182.12.89 Boehringer Ingelheim Investigational Site	San Diego	California	United States
13	1182.12.99 Boehringer Ingelheim Investigational Site	San Diego	California	United States
14	1182.12.25 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
15	1182.12.5 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
16	1182.12.53 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
17	1182.12.98 University of Colorado Health Sciences Center	Denver	Colorado	United States
18	1182.12.7 Boehringer Ingelheim Investigational Site	Norwalk	Connecticut	United States
19	1182.12.103 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
20	1182.12.52 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
21	1182.12.70	Washington	District of Columbia	United States
22	1182.12.79 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida	United States
23	1182.12.77 Boehringer Ingelheim Investigational Site	Fort Myers	Florida	United States
24	1182.12.93 Boehringer Ingelheim Investigational Site	Miami Beach	Florida	United States
25	1182.12.45 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
26	1182.12.75 CARES Resource	Miami	Florida	United States
27	1182.12.85 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
28	1182.12.17 Boehringer Ingelheim Investigational Site	Orlando	Florida	United States
29	1182.12.90 Boehringer Ingelheim Investigational Site	Sarasota	Florida	United States
30	1182.12.63 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
31	1182.12.78 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
32	1182.12.94 Infectious Disease Research Institute	Tampa	Florida	United States
33	1182.12.67 Boehringer Ingelheim Investigational Site	Vero Beach	Florida	United States
34	1182.12.123 Infectious Disease Clinics of Emory	Atlanta	Georgia	United States
35	1182.12.88 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
36	1182.12.72 Boehringer Ingelheim Investigational Site	Decatur	Georgia	United States
37	1182.12.47 Boehringer Ingelheim Investigational Site	Macon	Georgia	United States
38	1182.12.8 Family Practice Medical Center	Boise	Idaho	United States
39	1182.12.105 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
40	1182.12.3 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
41	1182.12.49 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
42	1182.12.32 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
43	1182.12.48 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
44	1182.12.33 Boehringer Ingelheim Investigational Site	Lexington	Kentucky	United States
45	1182.12.44 Boehringer Ingelheim Investigational Site	Louisville	Kentucky	United States
46	1182.12.95 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana	United States
47	1182.12.81 Boehringer Ingelheim Investigational Site	Portland	Maine	United States
48	1182.12.30 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
49	1182.12.6 Boehringer Ingelheim Investigational Site	Bethesda	Maryland	United States
50	1182.12.100 Boehringer Ingelheim Investigational Site	Boston	Massachusetts	United States
51	1182.12.101 Boehringer Ingelheim Investigational Site	Boston	Massachusetts	United States
52	1182.12.41 Boehringer Ingelheim Investigational Site	Boston	Massachusetts	United States
53	1182.12.61 Boehringer Ingelheim Investigational Site	Springfield	Massachusetts	United States
54	1182.12.13 University of Michigan Health System	Ann Arbor	Michigan	United States
55	1182.12.54 Boehringer Ingelheim Investigational Site	Detroit	Michigan	United States
56	1182.12.56 Boehringer Ingelheim Investigational Site	Detroit	Michigan	United States
57	1182.12.120 Department of Medicine, HIV/AIDS Program	Minneapolis	Minnesota	United States
58	1182.12.14 Dybedal Center for Clinical Research	Kansas City	Missouri	United States
59	1182.12.87 Boehringer Ingelheim Investigational Site	St Louis	Missouri	United States
60	1182.12.11 Wellness Center	Las Vegas	Nevada	United States
61	1182.12.4 Boehringer Ingelheim Investigational Site	Camden	New Jersey	United States
62	1182.12.21 Boehringer Ingelheim Investigational Site	East Orange	New Jersey	United States
63	1182.12.40 Boehringer Ingelheim Investigational Site	Santa Fe	New Mexico	United States
64	1182.12.68 Boehringer Ingelheim Investigational Site	Albany	New York	United States
65	1182.12.34 Boehringer Ingelheim Investigational Site	Mount Vernon	New York	United States
66	1182.12.119 Boehringer Ingelheim Investigational Site	New York	New York	United States
67	1182.12.22 Boehringer Ingelheim Investigational Site	New York	New York	United States
68	1182.12.36 Boehringer Ingelheim Investigational Site	New York	New York	United States
69	1182.12.58 Beth Israel Medical Center	New York	New York	United States
70	1182.12.96 Boehringer Ingelheim Investigational Site	New York	New York	United States
71	1182.12.107 Boehringer Ingelheim Investigational Site	Rochester	New York	United States
72	1182.12.83 Boehringer Ingelheim Investigational Site	Stony Brook	New York	United States
73	1182.12.43 Boehringer Ingelheim Investigational Site	Valhalla	New York	United States
74	1182.12.42 Boehringer Ingelheim Investigational Site	Durham	North Carolina	United States
75	1182.12.46 Boehringer Ingelheim Investigational Site	Huntersville	North Carolina	United States
76	1182.12.109 Boehringer Ingelheim Investigational Site	Akron	Ohio	United States
77	1182.12.24 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
78	1182.12.35 Boehringer Ingelheim Investigational Site	Cleveland	Ohio	United States
79	1182.12.65 Ohio State University Medical Center	Columbus	Ohio	United States
80	1182.12.80 Infectious Disease Institute Clinical Trials Unit	Oklahoma City	Oklahoma	United States
81	1182.12.114 Pinnacle Health	Harrisburg	Pennsylvania	United States
82	1182.12.28 University of Pennsylvania	Philadelphia	Pennsylvania	United States
83	1182.12.50 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania	United States
84	1182.12.86 The Miriam Hospital	Providence	Rhode Island	United States
85	1182.12.10 Boehringer Ingelheim Investigational Site	Columbia	South Carolina	United States
86	1182.12.116 Greenville Hospital System	Greenville	South Carolina	United States
87	1182.12.2 Boehringer Ingelheim Investigational Site	Memphis	Tennessee	United States
88	1182.12.106 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
89	1182.12.55 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
90	1182.12.31 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
91	1182.12.73 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
92	1182.12.26 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
93	1182.12.91 Boehringer Ingelheim Investigational Site	Annandale	Virginia	United States
94	1182.12.122 VCU Health Systems	Richmond	Virginia	United States
95	1182.12.15 Boehringer Ingelheim Investigational Site	Seattle	Washington	United States
96	1182.12.29 Boehringer Ingelheim Investigational Site	Milwaukee	Wisconsin	United States
97	1182.12.1401 St. Vincent's Hospital	Darlinghurst	New South Wales	Australia
98	1182.12.1405 AIDS Research Initiative / Ground Zero	Darlinghurst	New South Wales	Australia
99	1182.12.1407 Holdsworth House General Practice	Darlinghurst	New South Wales	Australia
100	1182.12.1408 407 Doctors Pty Ltd.	Darlinghurst	New South Wales	Australia
101	1182.12.1403 Albion Street Centre	Surry Hills	New South Wales	Australia
102	1182.12.1406 Gold Coast Sexual Health Clinic	Miami	Queensland	Australia
103	1182.12.1404 Alfred Hospital	Melbourne	Victoria	Australia
104	1182.12.11002 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia	Canada
105	1182.12.11010 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba	Canada
106	1182.12.11016 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia	Canada
107	1182.12.11012 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
108	1182.12.11001 Boehringer Ingelheim Investigational Site	Ottawa	Ontario	Canada
109	1182.12.11004 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
110	1182.12.11006 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
111	1182.12.11009 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
112	1182.12.11014 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
113	1182.12.11015 Boehringer Ingelheim Investigational Site	Monteal	Quebec	Canada
114	1182.12.11003 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
115	1182.12.11007 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
116	1182.12.11013 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
117	1182.12.60 Boehringer Ingelheim Investigational Site	Santurce		Puerto Rico

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00054717
• Other Study ID Numbers: 1182.12
• First Posted: Feb 10, 2003
• Last Update Posted: Jul 2, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: HIV Infections; Ritonavir; HIV Protease Inhibitors; Tipranavir; Protease Inhibitors

Study Results

Participant Flow

Pre-assignment Detail	In the study there were 630 patients entered as stated in the protocol section. There were 10 patients not treated and are not included within the Participant Flow Module or any other analysis.

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Period Title: Overall Study
STARTED	313	317
COMPLETED	51	18
NOT COMPLETED	262	299

Baseline Characteristics

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	Total
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)	Total of all reporting groups
Overall Participants	311	309	620
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.6 (7.9)	44.5 (7.1)	45.1 (7.5)
Sex: Female, Male (Count of Participants)
Female	33 10.6%	22 7.1%	55 8.9%
Male	278 89.4%	287 92.9%	565 91.1%

Outcome Measures

1. Primary Outcome

Title	Treatment Response at Week 48
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	At week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	33.80 10.9%	16.20 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

2. Primary Outcome

Title	Time to Treatment Failure Through 48 Weeks of Treatment
Description	Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	313	317
Median (Inter-Quartile Range) [Days]	113	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	Treatment Response at Week 24
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	41.8 13.4%	23.9 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

4. Secondary Outcome

Title	Treatment Response at Week 2
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	53.1 17.1%	34.3 11.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

5. Secondary Outcome

Title	Treatment Response at Week 4
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	52.4 16.8%	33.3 10.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

6. Secondary Outcome

Title	Treatment Response at Week 8
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	52.4 16.8%	33.3 10.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

7. Secondary Outcome

Title	Treatment Response at Week 16
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	45.7 14.7%	27.5 8.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

8. Secondary Outcome

Title	Treatment Response at Week 24
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	42.1 13.5%	23.6 7.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

9. Secondary Outcome

Title	Treatment Response at Week 32
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	37.9 12.2%	19.4 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

10. Secondary Outcome

Title	Treatment Response at Week 40
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	35.4 11.4%	17.8 5.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

11. Secondary Outcome

Title	Treatment Response at Week 48
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	33.8 10.9%	16.2 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

12. Secondary Outcome

Title	Treatment Response at Week 56
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	32.5 10.5%	15.9 5.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

13. Secondary Outcome

Title	Treatment Response at Week 64
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	31.3 10.1%	15.5 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

14. Secondary Outcome

Title	Treatment Response at Week 72
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	29.6 9.5%	14.9 4.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

15. Secondary Outcome

Title	Treatment Response at Week 80
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 80

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	28 9%	14.2 4.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

16. Secondary Outcome

Title	Treatment Response at Week 88
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 88

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	27.3 8.8%	12.9 4.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

17. Secondary Outcome

Title	Treatment Response at Week 96
Description	Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [percentage of participants]	26.7 8.6%	11.7 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Weighted by the size of enfuvirtide and protease inhibitor strata

18. Secondary Outcome

Title	Time to Treatment Failure Through 96 Weeks of Treatment
Description	time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Days]	114	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Log Rank
	Comments

19. Secondary Outcome

Title	Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Description	Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Days]	113	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Log Rank
	Comments

20. Secondary Outcome

Title	Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Description	Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Days]	116	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Log Rank
	Comments

21. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 2 through Week 96 (at any point during trial)

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	79.1 25.4%	50.5 16.3%

22. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	63.3 20.4%	40.1 13%

23. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	63.3 20.4%	40.1 13%

24. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	55.9 18%	34.3 11.1%

25. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	47.3 15.2%	26.5 8.6%

26. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	43.1 13.9%	22.3 7.2%

27. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	38.9 12.5%	19.1 6.2%

28. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	36.7 11.8%	17.5 5.7%

29. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	36.3 11.7%	16.2 5.2%

30. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	34.1 11%	15.5 5%

31. Secondary Outcome

Title	Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Description	Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Time Frame	Week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	34.1 11%	16.2 5.2%

32. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 2
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-1.36	-0.57

33. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 4
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-1.56	-0.46

34. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 8
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-1.6	-0.43

35. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 16
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-1.08	-0.32

36. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 24
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.81	-0.3

37. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 32
Time Frame	Baseline to Week 32

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.73	-0.24

38. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 40
Time Frame	Baseline to Week 40

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.74	-0.23

39. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 48
Time Frame	Baseline to Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.61	-0.24

40. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 56
Time Frame	Baseline to Week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.57	-0.23

41. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 64
Time Frame	Baseline to Week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.6	-0.23

42. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 72
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.65	-0.21

43. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 80
Time Frame	Baseline to Week 80

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.64	-0.21

44. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 88
Time Frame	Baseline to Week 88

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.64	-0.21

45. Secondary Outcome

Title	Median Change From Baseline in Viral Load to Week 96
Time Frame	Baseline to Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Log(Copies/mL)]	-0.6	-0.21

46. Secondary Outcome

Title	Mean Change From Baseline to Week 2 in CD4+ Cell Count
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	23 (48)	19 (63)

47. Secondary Outcome

Title	Mean Change From Baseline to Week 4 in CD4+ Cell Count
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	41 (69)	22 (64)

48. Secondary Outcome

Title	Mean Change From Baseline to Week 8 in CD4+ Cell Count
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	310	309
Mean (Standard Deviation) [Cells/mm3]	49 (72)	25 (72)

49. Secondary Outcome

Title	Mean Change From Baseline to Week 16 in CD4+ Cell Count
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	55 (92)	30 (78)

50. Secondary Outcome

Title	Mean Change From Baseline to Week 24 in CD4+ Cell Count
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	54 (86)	24 (77)

51. Secondary Outcome

Title	Mean Change From Baseline to Week 32 in CD4+ Cell Count
Time Frame	Baseline to Week 32

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	51 (91)	26 (87)

52. Secondary Outcome

Title	Mean Change From Baseline to Week 40 in CD4+ Cell Count
Time Frame	Baseline to Week 40

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	50 (100)	24 (84)

53. Secondary Outcome

Title	Mean Change From Baseline to Week 48 in CD4+ Cell Count
Time Frame	Baseline to Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	46 (95)	28 (86)

54. Secondary Outcome

Title	Mean Change From Baseline to Week 56 in CD4+ Cell Count
Time Frame	Baseline to Week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	52 (104)	26 (88)

55. Secondary Outcome

Title	Mean Change From Baseline to Week 64 in CD4+ Cell Count
Time Frame	Baseline to Week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	50 (107)	26 (94)

56. Secondary Outcome

Title	Mean Change From Baseline to Week 72 in CD4+ Cell Count
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	50 (113)	24 (96)

57. Secondary Outcome

Title	Mean Change From Baseline to Week 80 in CD4+ Cell Count
Time Frame	Baseline to Week 80

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	55 (122)	26 (93)

58. Secondary Outcome

Title	Mean Change From Baseline to Week 88 in CD4+ Cell Count
Time Frame	Baseline to Week 88

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	60 (126)	29 (100)

59. Secondary Outcome

Title	Mean Change From Baseline to Week 96 in CD4+ Cell Count
Time Frame	Baseline to Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Mean (Standard Deviation) [Cells/mm3]	60 (133)	28 (97)

60. Secondary Outcome

Title	Time to New CDC Class C Progression Event or Death.
Description	Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
Time Frame	after 48 weeks of treatment

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Median (Inter-Quartile Range) [Days]	448	284

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tipranavir(TPV)/Low Dose Ritonavir(r), Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9894
	Comments
	Method	Log Rank
	Comments

61. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 2 through Week 96 (at any point during trial)

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	53.4 17.2%	32.4 10.5%

62. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 2
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	14.8 4.8%	13.6 4.4%

63. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 4
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	28.3 9.1%	19.1 6.2%

64. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 8
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	37.3 12%	23.6 7.6%

65. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 16
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	35.7 11.5%	20.7 6.7%

66. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 24
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	34.4 11.1%	16.5 5.3%

67. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 32
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	week 32

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	32.8 10.5%	14.9 4.8%

68. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 40
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	32.8 10.5%	14.6 4.7%

69. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 48
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	30.5 9.8%	13.6 4.4%

70. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 56
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	29.6 9.5%	13.9 4.5%

71. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 64
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	28.6 9.2%	13.3 4.3%

72. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 72
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	28.9 9.3%	12.9 4.2%

73. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 80
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	Week 80

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	27.7 8.9%	13.6 4.4%

74. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 88
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	week 88

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	27.7 8.9%	12.6 4.1%

75. Secondary Outcome

Title	Virologic Response (VL < 400 Copies/ml) at Week 96
Description	Percentage of participants with Viral Load < 400 copies/mL
Time Frame	week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	26.7 8.6%	11.7 3.8%

76. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 2 through Week 96 (at any point during trial)

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	37.9 12.2%	20.4 6.6%

77. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 2
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	1.9 0.6%	1.9 0.6%

78. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 4
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	6.4 2.1%	4.2 1.4%

79. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 8
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	16.1 5.2%	8.1 2.6%

80. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 16
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	23.5 7.6%	9.4 3%

81. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 24
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	24.8 8%	10 3.2%

82. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 32
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	24.8 8%	10 3.2%

83. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 40
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	23.5 7.6%	8.4 2.7%

84. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 48
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	22.5 7.2%	9.7 3.1%

85. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 56
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 56

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	21.5 6.9%	10 3.2%

86. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 64
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 64

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	22.8 7.3%	10.7 3.5%

87. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 72
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	21.2 6.8%	11.3 3.7%

88. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 80
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 80

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	20.6 6.6%	10.7 3.5%

89. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 88
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 88

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	22.2 7.1%	9.7 3.1%

90. Secondary Outcome

Title	Virologic Response (VL < 50 Copies/ml) at Week 96
Description	Percentage of participants with Viral Load < 50 copies/mL
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	311	309
Number [Percentage of participants]	20.9 6.7%	9.4 3%

91. Secondary Outcome

Title	Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
Description	NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	240 Weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values

Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Measure Participants	304	304
Haemoglobin	1.3 0.4%	0.7 0.2%
White Blood Cell Count Increase	0 0%	0 0%
White Blood Cell Count Decrease	5.3 1.7%	5.3 1.7%
Platelets	2.0 0.6%	0.7 0.2%
Prothrombin Time	1.6 0.5%	2.0 0.6%
Alanine Transaminase (ALT)	13.5 4.3%	1.6 0.5%
Aspartate Transaminase (AST)	7.9 2.5%	1.6 0.5%
ALT or AST	15.1 4.9%	2.6 0.8%
Bilirubin, Total	1.0 0.3%	0.7 0.2%
Alkaline phosphatase	1.0 0.3%	0 0%
Amylase	11.8 3.8%	9.2 3%
Lipase	2.0 0.6%	1.3 0.4%
Cholesterol	23.7 7.6%	8.6 2.8%
Triglycerides	29.3 9.4%	15.5 5%
Glucose, increase	3.3 1.1%	2.0 0.6%
Glucose, decrease	0 0%	1.0 0.3%
Creatinine	2.0 0.6%	2.3 0.7%

Adverse Events

Time Frame	up to 240 weeks
Adverse Event Reporting Description	Adverse events were monitored throughout the study and reported in the case report form.
Arm/Group Title	Tipranavir(TPV)/Low Dose Ritonavir(r)		Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
Arm/Group Description	TPV 500 mg / Ritonavir 200 mg, twice daily		lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
All Cause Mortality
	Tipranavir(TPV)/Low Dose Ritonavir(r)		Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tipranavir(TPV)/Low Dose Ritonavir(r)		Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/311 (36.3%)		61/309 (19.7%)
Blood and lymphatic system disorders
Anemia	6/311 (1.9%)		4/309 (1.3%)
Febrile neutropenia	2/311 (0.6%)		0/309 (0%)
Leukopenia	1/311 (0.3%)		0/309 (0%)
Lymphadenopathy	1/311 (0.3%)		0/309 (0%)
Lymphopenia	0/311 (0%)		1/309 (0.3%)
Methaemoglobinaemia	1/311 (0.3%)		0/309 (0%)
Neutropenia	2/311 (0.6%)		0/309 (0%)
Pancytopenia	0/311 (0%)		1/309 (0.3%)
Thrombocytopenia	0/311 (0%)		1/309 (0.3%)
Cardiac disorders
Acute coronary syndrome	0/311 (0%)		1/309 (0.3%)
Angina pectoris	0/311 (0%)		1/309 (0.3%)
Aortic valve incompetence	1/311 (0.3%)		1/309 (0.3%)
Atrial fibrillation	1/311 (0.3%)		0/309 (0%)
Cardiac disorder	1/311 (0.3%)		0/309 (0%)
Cardiac failure	1/311 (0.3%)		0/309 (0%)
Cardiac failure congestive	3/311 (1%)		1/309 (0.3%)
Cardiac tamponade	0/311 (0%)		1/309 (0.3%)
Cardio-respiratory arrest	1/311 (0.3%)		0/309 (0%)
Coronary artery disease	2/311 (0.6%)		1/309 (0.3%)
Hypertrophic cardiomyopathy	1/311 (0.3%)		0/309 (0%)
Left ventricular dysfunction	0/311 (0%)		1/309 (0.3%)
Myocardial infarction	0/311 (0%)		1/309 (0.3%)
Myocardial ischaemia	1/311 (0.3%)		0/309 (0%)
Ventricle rupture	0/311 (0%)		1/309 (0.3%)
Congenital, familial and genetic disorders
Atrial septal defect	0/311 (0%)		1/309 (0.3%)
Fanconi syndrome	1/311 (0.3%)		0/309 (0%)
Endocrine disorders
Hypothyroidism	1/311 (0.3%)		0/309 (0%)
Eye disorders
Mydriasis	1/311 (0.3%)		0/309 (0%)
Retinal detachment	1/311 (0.3%)		0/309 (0%)
Sudden visual loss	1/311 (0.3%)		0/309 (0%)
Visual impairment	1/311 (0.3%)		0/309 (0%)
Gastrointestinal disorders
Abdominal pain	3/311 (1%)		0/309 (0%)
Abdominal pain upper	1/311 (0.3%)		0/309 (0%)
Anorectal disorder	1/311 (0.3%)		0/309 (0%)
Appendicitis perforated	1/311 (0.3%)		0/309 (0%)
Ascites	1/311 (0.3%)		0/309 (0%)
Colitis	0/311 (0%)		1/309 (0.3%)
Constipation	0/311 (0%)		1/309 (0.3%)
Diarrhoea	9/311 (2.9%)		3/309 (1%)
Duodenitis	1/311 (0.3%)		0/309 (0%)
Dysphagia	2/311 (0.6%)		1/309 (0.3%)
Gastrointestinal haemorrhage	1/311 (0.3%)		0/309 (0%)
Haematemesis	1/311 (0.3%)		0/309 (0%)
Haemorrhoidal haemorrhage	1/311 (0.3%)		0/309 (0%)
Impaired gastric emptying	1/311 (0.3%)		0/309 (0%)
Intestinal obstruction	0/311 (0%)		1/309 (0.3%)
Large intestinal ulcer	1/311 (0.3%)		0/309 (0%)
Nausea	3/311 (1%)		0/309 (0%)
Odynophagia	0/311 (0%)		1/309 (0.3%)
Oesophagitis	1/311 (0.3%)		0/309 (0%)
Pancreatitis	4/311 (1.3%)		1/309 (0.3%)
Periproctitis	0/311 (0%)		1/309 (0.3%)
Peritoneal adhesions	1/311 (0.3%)		0/309 (0%)
Proctalgia	1/311 (0.3%)		0/309 (0%)
Proctitis	0/311 (0%)		1/309 (0.3%)
Rectal haemorrhage	1/311 (0.3%)		0/309 (0%)
Stomatitis necrotising	1/311 (0.3%)		0/309 (0%)
Upper gastrointestinal haemorrhage	0/311 (0%)		1/309 (0.3%)
Varices oesophageal	1/311 (0.3%)		0/309 (0%)
Vomiting	5/311 (1.6%)		0/309 (0%)
General disorders
Asthenia	2/311 (0.6%)		1/309 (0.3%)
Chest pain	4/311 (1.3%)		3/309 (1%)
Chills	3/311 (1%)		0/309 (0%)
Cyst	1/311 (0.3%)		0/309 (0%)
Death	3/311 (1%)		1/309 (0.3%)
Drug withdrawal syndrome	0/311 (0%)		1/309 (0.3%)
Fatigue	0/311 (0%)		1/309 (0.3%)
Granuloma	1/311 (0.3%)		1/309 (0.3%)
Hypothermia	1/311 (0.3%)		0/309 (0%)
Malaise	0/311 (0%)		1/309 (0.3%)
Necrosis	1/311 (0.3%)		0/309 (0%)
Oedema peripheral	1/311 (0.3%)		0/309 (0%)
Pain	1/311 (0.3%)		0/309 (0%)
Pyrexia	11/311 (3.5%)		3/309 (1%)
Hepatobiliary disorders
Cholecystitis	0/311 (0%)		1/309 (0.3%)
Cholelithiasis	1/311 (0.3%)		0/309 (0%)
Hepatic failure	1/311 (0.3%)		0/309 (0%)
Hepatosplenomegaly	1/311 (0.3%)		0/309 (0%)
Portal vein thrombosis	1/311 (0.3%)		0/309 (0%)
Immune system disorders
Drug hypersensitivity	0/311 (0%)		1/309 (0.3%)
Immune reconstitution syndrome	1/311 (0.3%)		0/309 (0%)
Infections and infestations
Abdominal abscess	0/311 (0%)		1/309 (0.3%)
Abscess jaw	1/311 (0.3%)		0/309 (0%)
Abscess neck	1/311 (0.3%)		0/309 (0%)
Acquired immunodeficiency syndrome	1/311 (0.3%)		0/309 (0%)
Acute sinusitis	0/311 (0%)		1/309 (0.3%)
Anal abscess	0/311 (0%)		1/309 (0.3%)
Anogenital warts	1/311 (0.3%)		0/309 (0%)
Appendicitis	2/311 (0.6%)		0/309 (0%)
Arthritis bacterial	1/311 (0.3%)		0/309 (0%)
Bacteraemia	1/311 (0.3%)		1/309 (0.3%)
Bronchitis	2/311 (0.6%)		1/309 (0.3%)
Campylobacter infection	1/311 (0.3%)		0/309 (0%)
Candidiasis	2/311 (0.6%)		0/309 (0%)
Catheter related infection	1/311 (0.3%)		0/309 (0%)
Cavernous sinus thrombosis	1/311 (0.3%)		0/309 (0%)
Cellulitis	3/311 (1%)		1/309 (0.3%)
Cerebral toxoplasmosis	1/311 (0.3%)		0/309 (0%)
Clostridial infection	1/311 (0.3%)		0/309 (0%)
Clostridium difficile colitis	1/311 (0.3%)		0/309 (0%)
Cytomegalovirus chorioretinitis	2/311 (0.6%)		1/309 (0.3%)
Cytomegalovirus colitis	1/311 (0.3%)		0/309 (0%)
Cytomegalovirus gastritis	0/311 (0%)		1/309 (0.3%)
Cytomegalovirus infection	1/311 (0.3%)		0/309 (0%)
Cytomegalovirus oesophagitis	0/311 (0%)		2/309 (0.6%)
Disseminated cryptococcosis	1/311 (0.3%)		0/309 (0%)
Diverticulitis	1/311 (0.3%)		0/309 (0%)
End stage AIDS	1/311 (0.3%)		1/309 (0.3%)
Enteritis infectious	1/311 (0.3%)		0/309 (0%)
Gangrene	0/311 (0%)		1/309 (0.3%)
Gastroenteritis	4/311 (1.3%)		0/309 (0%)
Groin abscess	1/311 (0.3%)		0/309 (0%)
HIV infection	3/311 (1%)		0/309 (0%)
Herpes oesophagitis	1/311 (0.3%)		0/309 (0%)
Herpes virus infection	2/311 (0.6%)		0/309 (0%)
Influenza	0/311 (0%)		1/309 (0.3%)
Injection site cellulitis	0/311 (0%)		1/309 (0.3%)
Keratitis bacterial	1/311 (0.3%)		0/309 (0%)
Lobar pneumonia	3/311 (1%)		0/309 (0%)
Lung infection pseudomonal	0/311 (0%)		1/309 (0.3%)
Meningitis	1/311 (0.3%)		0/309 (0%)
Meningitis aseptic	1/311 (0.3%)		0/309 (0%)
Meningitis cryptococcal	1/311 (0.3%)		0/309 (0%)
Molluscum contagiosum	0/311 (0%)		1/309 (0.3%)
Mycobacterium avium complex infection	0/311 (0%)		1/309 (0.3%)
Nosocomial infection	0/311 (0%)		1/309 (0.3%)
Oesophageal candidiasis	5/311 (1.6%)		3/309 (1%)
Oral infection	1/311 (0.3%)		0/309 (0%)
Osteomyelitis	2/311 (0.6%)		0/309 (0%)
Perineal abscess	1/311 (0.3%)		0/309 (0%)
Periorbital cellulitis	1/311 (0.3%)		0/309 (0%)
Pneumocystis jiroveci pneumonia	7/311 (2.3%)		2/309 (0.6%)
Pneumonia	13/311 (4.2%)		2/309 (0.6%)
Pneumonia bacterial	1/311 (0.3%)		0/309 (0%)
Pneumonia cytomegaloviral	0/311 (0%)		1/309 (0.3%)
Pneumonia streptococcal	0/311 (0%)		1/309 (0.3%)
Progressive multifocal leukoencephalopathy	1/311 (0.3%)		0/309 (0%)
Pseudomonal bacteraemia	0/311 (0%)		1/309 (0.3%)
Pseudomonas infection	1/311 (0.3%)		0/309 (0%)
Pyelonephritis	2/311 (0.6%)		0/309 (0%)
Scrotal abscess	1/311 (0.3%)		0/309 (0%)
Sepsis	4/311 (1.3%)		0/309 (0%)
Shigella infection	1/311 (0.3%)		0/309 (0%)
Sinusitis	3/311 (1%)		0/309 (0%)
Staphylococcal bacteraemia	1/311 (0.3%)		0/309 (0%)
Staphylococcal infection	3/311 (1%)		1/309 (0.3%)
Staphylococcal sepsis	1/311 (0.3%)		0/309 (0%)
Subcutaneous abscess	1/311 (0.3%)		1/309 (0.3%)
Thrombophlebitis septic	1/311 (0.3%)		0/309 (0%)
Toxoplasmosis	1/311 (0.3%)		0/309 (0%)
Urinary tract infection	1/311 (0.3%)		0/309 (0%)
Urosepsis	1/311 (0.3%)		1/309 (0.3%)
Viral infection	0/311 (0%)		1/309 (0.3%)
Viral pericarditis	1/311 (0.3%)		0/309 (0%)
Viral pharyngitis	0/311 (0%)		1/309 (0.3%)
Injury, poisoning and procedural complications
Arterial injury	0/311 (0%)		1/309 (0.3%)
Back injury	1/311 (0.3%)		0/309 (0%)
Brain herniation	1/311 (0.3%)		0/309 (0%)
Fall	1/311 (0.3%)		1/309 (0.3%)
Foreign body trauma	0/311 (0%)		1/309 (0.3%)
Hip fracture	4/311 (1.3%)		0/309 (0%)
Ligament injury	0/311 (0%)		1/309 (0.3%)
Muscle rupture	0/311 (0%)		1/309 (0.3%)
Muscle strain	1/311 (0.3%)		0/309 (0%)
Patella fracture	0/311 (0%)		1/309 (0.3%)
Post lumbar puncture syndrome	1/311 (0.3%)		1/309 (0.3%)
Radius fracture	0/311 (0%)		1/309 (0.3%)
Road traffic accident	2/311 (0.6%)		1/309 (0.3%)
Stress fracture	1/311 (0.3%)		0/309 (0%)
Vascular pseudoaneurysm ruptured	0/311 (0%)		1/309 (0.3%)
Wrist fracture	1/311 (0.3%)		1/309 (0.3%)
Investigations
Alanine aminotransferase increased	3/311 (1%)		0/309 (0%)
Aspartate aminotransferase increased	3/311 (1%)		0/309 (0%)
Blood creatine increased	1/311 (0.3%)		0/309 (0%)
Blood creatinine increased	1/311 (0.3%)		0/309 (0%)
Blood triglycerides increased	1/311 (0.3%)		1/309 (0.3%)
Drug level increased	0/311 (0%)		1/309 (0.3%)
Gamma-glutamyltransferase increased	1/311 (0.3%)		0/309 (0%)
Haemoglobin decreased	0/311 (0%)		1/309 (0.3%)
International normalised ratio increased	0/311 (0%)		1/309 (0.3%)
Prothrombin time prolonged	0/311 (0%)		1/309 (0.3%)
Volume blood decreased	0/311 (0%)		1/309 (0.3%)
Weight decreased	1/311 (0.3%)		0/309 (0%)
Metabolism and nutrition disorders
Acidosis	1/311 (0.3%)		0/309 (0%)
Anorexia	2/311 (0.6%)		0/309 (0%)
Cachexia	1/311 (0.3%)		1/309 (0.3%)
Dehydration	10/311 (3.2%)		2/309 (0.6%)
Diabetes mellitus	0/311 (0%)		1/309 (0.3%)
Electrolyte imbalance	1/311 (0.3%)		1/309 (0.3%)
Hypocalcaemia	2/311 (0.6%)		0/309 (0%)
Hypokalaemia	1/311 (0.3%)		0/309 (0%)
Hypovolaemia	0/311 (0%)		1/309 (0.3%)
Lactic acidosis	1/311 (0.3%)		0/309 (0%)
Malnutrition	3/311 (1%)		1/309 (0.3%)
Metabolic acidosis	1/311 (0.3%)		0/309 (0%)
Type 1 diabetes mellitus	1/311 (0.3%)		0/309 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/311 (0.3%)		0/309 (0%)
Back pain	0/311 (0%)		1/309 (0.3%)
Flank pain	1/311 (0.3%)		0/309 (0%)
Groin pain	1/311 (0.3%)		0/309 (0%)
Intervertebral disc protrusion	1/311 (0.3%)		0/309 (0%)
Muscle spasms	1/311 (0.3%)		0/309 (0%)
Muscular weakness	1/311 (0.3%)		0/309 (0%)
Musculoskeletal chest pain	1/311 (0.3%)		0/309 (0%)
Neck mass	1/311 (0.3%)		0/309 (0%)
Neck pain	1/311 (0.3%)		0/309 (0%)
Osteoarthritis	0/311 (0%)		1/309 (0.3%)
Osteonecrosis	1/311 (0.3%)		0/309 (0%)
Pain in extremity	2/311 (0.6%)		0/309 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/311 (0%)		1/309 (0.3%)
Adenocarcinoma	1/311 (0.3%)		0/309 (0%)
Anal cancer	1/311 (0.3%)		1/309 (0.3%)
B-cell lymphoma	1/311 (0.3%)		0/309 (0%)
Basal cell carcinoma	3/311 (1%)		1/309 (0.3%)
Bladder cancer	1/311 (0.3%)		0/309 (0%)
Bowen's disease	0/311 (0%)		1/309 (0.3%)
Central nervous system lymphoma	2/311 (0.6%)		2/309 (0.6%)
Diffuse large B-cell lymphoma	1/311 (0.3%)		0/309 (0%)
Hodgkin's disease	3/311 (1%)		0/309 (0%)
Kaposi's sarcoma	1/311 (0.3%)		0/309 (0%)
Lipoma	1/311 (0.3%)		0/309 (0%)
Lymphoma	2/311 (0.6%)		3/309 (1%)
Malignant melanoma	1/311 (0.3%)		0/309 (0%)
Metastatic malignant melanoma	1/311 (0.3%)		0/309 (0%)
Metastatic neoplasm	1/311 (0.3%)		0/309 (0%)
Non-Hodgkin's lymphoma	2/311 (0.6%)		0/309 (0%)
Prostate cancer	2/311 (0.6%)		0/309 (0%)
Rectal cancer	0/311 (0%)		1/309 (0.3%)
Rectal cancer metastatic	1/311 (0.3%)		0/309 (0%)
Rectal cancer stage 0	1/311 (0.3%)		0/309 (0%)
Squamous cell carcinoma of skin	0/311 (0%)		1/309 (0.3%)
Vulval cancer	1/311 (0.3%)		0/309 (0%)
Nervous system disorders
Ataxia	1/311 (0.3%)		1/309 (0.3%)
Balance disorder	0/311 (0%)		1/309 (0.3%)
Carotid artery stenosis	1/311 (0.3%)		0/309 (0%)
Central nervous system lesion	1/311 (0.3%)		0/309 (0%)
Cerebral haemorrhage	1/311 (0.3%)		0/309 (0%)
Cerebrovascular accident	2/311 (0.6%)		0/309 (0%)
Convulsion	3/311 (1%)		2/309 (0.6%)
Demyelinating polyneuropathy	1/311 (0.3%)		0/309 (0%)
Diabetic hyperglycaemic coma	0/311 (0%)		1/309 (0.3%)
Embolic stroke	0/311 (0%)		1/309 (0.3%)
Encephalopathy	1/311 (0.3%)		0/309 (0%)
Haemorrhage intracranial	1/311 (0.3%)		0/309 (0%)
Headache	3/311 (1%)		1/309 (0.3%)
Hemicephalalgia	1/311 (0.3%)		0/309 (0%)
Hemiparesis	1/311 (0.3%)		0/309 (0%)
Lethargy	0/311 (0%)		1/309 (0.3%)
Mental retardation	1/311 (0.3%)		0/309 (0%)
Metabolic encephalopathy	0/311 (0%)		1/309 (0.3%)
Migraine	0/311 (0%)		1/309 (0.3%)
Muscle spasticity	1/311 (0.3%)		0/309 (0%)
Nervous system disorder	1/311 (0.3%)		0/309 (0%)
Neurological symptom	1/311 (0.3%)		0/309 (0%)
Polyneuropathy	1/311 (0.3%)		0/309 (0%)
Radiculopathy	0/311 (0%)		1/309 (0.3%)
Syncope	0/311 (0%)		1/309 (0.3%)
Thalamus haemorrhage	1/311 (0.3%)		0/309 (0%)
Tremor	1/311 (0.3%)		0/309 (0%)
Psychiatric disorders
Completed suicide	0/311 (0%)		1/309 (0.3%)
Confusional state	1/311 (0.3%)		2/309 (0.6%)
Depression	0/311 (0%)		3/309 (1%)
Drug abuse	1/311 (0.3%)		0/309 (0%)
Major depression	0/311 (0%)		3/309 (1%)
Mental status changes	1/311 (0.3%)		0/309 (0%)
Renal and urinary disorders
Fanconi syndrome acquired	1/311 (0.3%)		0/309 (0%)
Focal segmental glomerulosclerosis	0/311 (0%)		1/309 (0.3%)
Incontinence	0/311 (0%)		1/309 (0.3%)
Nephrolithiasis	1/311 (0.3%)		0/309 (0%)
Renal colic	1/311 (0.3%)		0/309 (0%)
Renal failure	4/311 (1.3%)		1/309 (0.3%)
Renal failure acute	9/311 (2.9%)		2/309 (0.6%)
Renal failure chronic	1/311 (0.3%)		0/309 (0%)
Renal tubular acidosis	1/311 (0.3%)		0/309 (0%)
Reproductive system and breast disorders
Testicular mass	0/311 (0%)		1/309 (0.3%)
Vulvar dysplasia	1/311 (0.3%)		0/309 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/311 (0.3%)		0/309 (0%)
Chronic obstructive pulmonary disease	1/311 (0.3%)		0/309 (0%)
Cough	1/311 (0.3%)		0/309 (0%)
Dyspnoea	5/311 (1.6%)		2/309 (0.6%)
Hypoxia	0/311 (0%)		1/309 (0.3%)
Interstitial lung disease	1/311 (0.3%)		0/309 (0%)
Organising pneumonia	1/311 (0.3%)		0/309 (0%)
Pleuritic pain	0/311 (0%)		1/309 (0.3%)
Pneumomediastinum	1/311 (0.3%)		0/309 (0%)
Pneumonia aspiration	1/311 (0.3%)		0/309 (0%)
Pneumothorax	2/311 (0.6%)		1/309 (0.3%)
Productive cough	0/311 (0%)		1/309 (0.3%)
Pulmonary embolism	2/311 (0.6%)		0/309 (0%)
Pulmonary oedema	1/311 (0.3%)		0/309 (0%)
Respiratory alkalosis	1/311 (0.3%)		0/309 (0%)
Respiratory distress	2/311 (0.6%)		0/309 (0%)
Respiratory failure	1/311 (0.3%)		0/309 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/311 (0.3%)		0/309 (0%)
Night sweats	1/311 (0.3%)		0/309 (0%)
Rash	1/311 (0.3%)		0/309 (0%)
Rash macular	1/311 (0.3%)		0/309 (0%)
Surgical and medical procedures
Abortion induced	1/311 (0.3%)		0/309 (0%)
Coronary arterial stent insertion	0/311 (0%)		1/309 (0.3%)
Drug detoxification	0/311 (0%)		1/309 (0.3%)
Intestinal anastomosis	1/311 (0.3%)		0/309 (0%)
Intestinal operation	1/311 (0.3%)		0/309 (0%)
Umbilical hernia repair	1/311 (0.3%)		0/309 (0%)
Vascular disorders
Aortic aneurysm	1/311 (0.3%)		0/309 (0%)
Aortic stenosis	1/311 (0.3%)		0/309 (0%)
Arterial haemorrhage	0/311 (0%)		1/309 (0.3%)
Arterial rupture	0/311 (0%)		1/309 (0.3%)
Arteriosclerosis	1/311 (0.3%)		0/309 (0%)
Deep vein thrombosis	2/311 (0.6%)		2/309 (0.6%)
Exsanguination	0/311 (0%)		1/309 (0.3%)
Hypertension	2/311 (0.6%)		0/309 (0%)
Hypotension	2/311 (0.6%)		0/309 (0%)
Pelvic venous thrombosis	1/311 (0.3%)		0/309 (0%)
Thrombosis	0/311 (0%)		1/309 (0.3%)
Other (Not Including Serious) Adverse Events
	Tipranavir(TPV)/Low Dose Ritonavir(r)		Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	301/311 (96.8%)		271/309 (87.7%)
Blood and lymphatic system disorders
Anaemia	25/311 (8%)		6/309 (1.9%)
Gastrointestinal disorders
Abdominal distension	27/311 (8.7%)		20/309 (6.5%)
Abdominal pain	31/311 (10%)		25/309 (8.1%)
Constipation	21/311 (6.8%)		13/309 (4.2%)
Diarrhoea	123/311 (39.5%)		90/309 (29.1%)
Gastrooesophageal reflux disease	22/311 (7.1%)		14/309 (4.5%)
Nausea	88/311 (28.3%)		78/309 (25.2%)
Vomiting	56/311 (18%)		37/309 (12%)
General disorders
Adverse drug reaction	23/311 (7.4%)		19/309 (6.1%)
Fatigue	71/311 (22.8%)		63/309 (20.4%)
Injection site reaction	30/311 (9.6%)		32/309 (10.4%)
Oedema peripheral	16/311 (5.1%)		13/309 (4.2%)
Pain	19/311 (6.1%)		17/309 (5.5%)
Pyrexia	46/311 (14.8%)		27/309 (8.7%)
Infections and infestations
Bronchitis	38/311 (12.2%)		17/309 (5.5%)
Candidiasis	16/311 (5.1%)		20/309 (6.5%)
Folliculitis	17/311 (5.5%)		10/309 (3.2%)
Influenza	19/311 (6.1%)		5/309 (1.6%)
Nasopharyngitis	32/311 (10.3%)		16/309 (5.2%)
Oral candidiasis	23/311 (7.4%)		13/309 (4.2%)
Sinusitis	41/311 (13.2%)		26/309 (8.4%)
Upper respiratory tract infection	62/311 (19.9%)		37/309 (12%)
Urinary tract infection	16/311 (5.1%)		7/309 (2.3%)
Investigations
Weight decreased	23/311 (7.4%)		21/309 (6.8%)
Metabolism and nutrition disorders
Decreased appetite	21/311 (6.8%)		10/309 (3.2%)
Hyperlipidaemia	29/311 (9.3%)		7/309 (2.3%)
Hypertriglyceridaemia	16/311 (5.1%)		2/309 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	36/311 (11.6%)		31/309 (10%)
Back pain	42/311 (13.5%)		23/309 (7.4%)
Muscle spasms	20/311 (6.4%)		14/309 (4.5%)
Myalgia	26/311 (8.4%)		16/309 (5.2%)
Pain in extremity	29/311 (9.3%)		14/309 (4.5%)
Nervous system disorders
Dizziness	27/311 (8.7%)		19/309 (6.1%)
Headache	53/311 (17%)		36/309 (11.7%)
Neuropathy peripheral	21/311 (6.8%)		14/309 (4.5%)
Psychiatric disorders
Anxiety	16/311 (5.1%)		12/309 (3.9%)
Depression	35/311 (11.3%)		26/309 (8.4%)
Insomnia	32/311 (10.3%)		30/309 (9.7%)
Reproductive system and breast disorders
Erectile dysfunction	16/311 (5.1%)		9/309 (2.9%)
Respiratory, thoracic and mediastinal disorders
Cough	56/311 (18%)		26/309 (8.4%)
Nasal congestion	17/311 (5.5%)		13/309 (4.2%)
Oropharyngeal pain	19/311 (6.1%)		12/309 (3.9%)
Skin and subcutaneous tissue disorders
Night sweats	18/311 (5.8%)		15/309 (4.9%)
Rash	35/311 (11.3%)		33/309 (10.7%)
Vascular disorders
Hypertension	16/311 (5.1%)		14/309 (4.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.