Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Tipranavir(TPV)/Low Dose Ritonavir(r)	TPV 500 mg / Ritonavir 200 mg, twice daily
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)

Participant Flow:   Overall Study

	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)
STARTED	311	309
COMPLETED	51	18
NOT COMPLETED	260	291
Adverse Event	70	22
Protocol Violation	19	19
Lost to Follow-up	23	13
Withdrawal by Subject	33	20
Lack of Efficacy or Viral load failure	79	200
Investigator decision	5	2
Site closure	5	2
Lost to follow-up or moved	5	0
Enrolled into other trial	4	6
Drug abuse	0	1
Pill Fatigue	1	0
Safety concerns	1	0
Declining CD4 count	1	0
Switch to commercial product	1	2
Viremia	1	0
Started new HIV regimen	2	0
Drug intolerance	0	1
Missing	6	2
Death	4	1

Reporting Groups

	Description
Tipranavir(TPV)/Low Dose Ritonavir(r)	TPV 500 mg / Ritonavir 200 mg, twice daily
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)

Baseline Measures

	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	Total
Number of Participants   [units: participants]	311	309	620
Age   [units: years] Mean ± Standard Deviation	45.6 ± 7.9	44.5 ± 7.1	45.1 ± 7.5
Gender   [units: participants]
Female	33	22	55
Male	278	287	565

1.  Primary:

Treatment Response at Week 48   [ At week 48 ]

2.  Primary:

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

3.  Secondary:

Treatment Response at Week 24   [ Week 24 ]

4.  Secondary:

Treatment Response at Week 2   [ week 2 ]

5.  Secondary:

Treatment Response at Week 4   [ week 4 ]

6.  Secondary:

Treatment Response at Week 8   [ week 8 ]

7.  Secondary:

Treatment Response at Week 16   [ week 16 ]

8.  Secondary:

Treatment Response at Week 24   [ week 24 ]

9.  Secondary:

Treatment Response at Week 32   [ Week 32 ]

10.  Secondary:

Treatment Response at Week 40   [ Week 40 ]

11.  Secondary:

Treatment Response at Week 48   [ Week 48 ]

12.  Secondary:

Treatment Response at Week 56   [ week 56 ]

13.  Secondary:

Treatment Response at Week 64   [ week 64 ]

14.  Secondary:

Treatment Response at Week 72   [ Week 72 ]

15.  Secondary:

Treatment Response at Week 80   [ Week 80 ]

16.  Secondary:

Treatment Response at Week 88   [ Week 88 ]

17.  Secondary:

Treatment Response at Week 96   [ Week 96 ]

18.  Secondary:

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

19.  Secondary:

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

20.  Secondary:

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

21.  Secondary:

Virologic Response   [ Week 2 through Week 96 (at any point during trial) ]

22.  Secondary:

Virologic Response at Week 2   [ Week 2 ]

23.  Secondary:

Virologic Response at Week 4   [ Week 4 ]

24.  Secondary:

Virologic Response at Week 8   [ Week 8 ]

25.  Secondary:

Virologic Response at Week 16   [ Week 16 ]

26.  Secondary:

Virologic Response at Week 24   [ Week 24 ]

27.  Secondary:

Virologic Response at Week 32   [ Week 32 ]

28.  Secondary:

Virologic Response at Week 40   [ Week 40 ]

29.  Secondary:

Virologic Response at Week 48   [ Week 48 ]

30.  Secondary:

Virologic Response at Week 56   [ Week 56 ]

31.  Secondary:

Virologic Response at Week 64   [ Week 64 ]

32.  Secondary:

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

33.  Secondary:

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

34.  Secondary:

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

35.  Secondary:

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

36.  Secondary:

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

37.  Secondary:

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

38.  Secondary:

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

39.  Secondary:

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

40.  Secondary:

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

41.  Secondary:

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

42.  Secondary:

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

43.  Secondary:

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

44.  Secondary:

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

45.  Secondary:

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

46.  Secondary:

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

47.  Secondary:

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

48.  Secondary:

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

49.  Secondary:

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

50.  Secondary:

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

51.  Secondary:

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

52.  Secondary:

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

53.  Secondary:

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

54.  Secondary:

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

55.  Secondary:

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

56.  Secondary:

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

57.  Secondary:

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

58.  Secondary:

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

59.  Secondary:

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

60.  Secondary:

Virologic Response   [ Week 2 through Week 96 (at any point during trial) ]

61.  Secondary:

Virologic Response at Week 2   [ Week 2 ]

62.  Secondary:

Virologic Response at Week 4   [ Week 4 ]

63.  Secondary:

Virologic Response at Week 8   [ Week 8 ]

64.  Secondary:

Virologic Response at Week 16   [ Week 16 ]

65.  Secondary:

Virologic Response at Week 24   [ Week 24 ]

66.  Secondary:

Virologic Response at Week 32   [ week 32 ]

67.  Secondary:

Virologic Response at Week 40   [ Week 40 ]

68.  Secondary:

Virologic Response at Week 48   [ Week 48 ]

69.  Secondary:

Virologic Response at Week 56   [ Week 56 ]

70.  Secondary:

Virologic Response at Week 64   [ Week 64 ]

71.  Secondary:

Virologic Response at Week 72   [ Week 72 ]

72.  Secondary:

Virologic Response at Week 80   [ Week 80 ]

73.  Secondary:

Virologic Response at Week 88   [ week 88 ]

74.  Secondary:

Virologic Response at Week 96   [ week 96 ]

75.  Secondary:

Virologic Response   [ Week 2 through Week 96 (at any point during trial) ]

76.  Secondary:

Virologic Response at Week 2   [ Week 2 ]

77.  Secondary:

Virologic Response at Week 4   [ Week 4 ]

78.  Secondary:

Virologic Response at Week 8   [ Week 8 ]

79.  Secondary:

Virologic Response at Week 16   [ Week 16 ]

80.  Secondary:

Virologic Response at Week 24   [ Week 24 ]

81.  Secondary:

Virologic Response at Week 32   [ Week 32 ]

82.  Secondary:

Virologic Response at Week 40   [ Week 40 ]

83.  Secondary:

Virologic Response at Week 48   [ Week 48 ]

84.  Secondary:

Virologic Response at Week 56   [ Week 56 ]

85.  Secondary:

Virologic Response at Week 64   [ Week 64 ]

86.  Secondary:

Virologic Response at Week 72   [ Week 72 ]

87.  Secondary:

Virologic Response at Week 80   [ Week 80 ]

88.  Secondary:

Virologic Response at Week 88   [ Week 88 ]

89.  Secondary:

Virologic Response at Week 96   [ Week 96 ]