Trial Outcomes & Findings for Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) (NCT NCT00054717)

Last Updated: 2014-07-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

630 participants

Primary outcome timeframe

At week 48

Results posted on

2014-07-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	313	317
Overall Study COMPLETED	51	18
Overall Study NOT COMPLETED	262	299

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Randomized but not treated	2	8
Overall Study Adverse Event	70	22
Overall Study Protocol Violation	18	19
Overall Study Lost to Follow-up	23	13
Overall Study Withdrawal by Subject	32	20
Overall Study Other reason not defined above	117	217

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)	Total n=620 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	44.5 years STANDARD_DEVIATION 7.1 • n=7 Participants	45.1 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	22 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	278 Participants n=5 Participants	287 Participants n=7 Participants	565 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 48

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 48	33.80 percentage of participants	16.20 percentage of participants

PRIMARY outcome

Timeframe: Week 48

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

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.

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=313 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=317 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Time to Treatment Failure Through 48 Weeks of Treatment	113 Days Interval 0.0 to 395.0	0 Days Interval 0.0 to 171.0

SECONDARY outcome

Timeframe: Week 24

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 24	41.8 percentage of participants	23.9 percentage of participants

SECONDARY outcome

Timeframe: week 2

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 2	53.1 percentage of participants	34.3 percentage of participants

SECONDARY outcome

Timeframe: week 4

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 4	52.4 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: week 8

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 8	52.4 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: week 16

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 16	45.7 percentage of participants	27.5 percentage of participants

SECONDARY outcome

Timeframe: week 24

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 24	42.1 percentage of participants	23.6 percentage of participants

SECONDARY outcome

Timeframe: Week 32

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 32	37.9 percentage of participants	19.4 percentage of participants

SECONDARY outcome

Timeframe: Week 40

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 40	35.4 percentage of participants	17.8 percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 48	33.8 percentage of participants	16.2 percentage of participants

SECONDARY outcome

Timeframe: week 56

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 56	32.5 percentage of participants	15.9 percentage of participants

SECONDARY outcome

Timeframe: week 64

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 64	31.3 percentage of participants	15.5 percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 72	29.6 percentage of participants	14.9 percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 80	28 percentage of participants	14.2 percentage of participants

SECONDARY outcome

Timeframe: Week 88

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 88	27.3 percentage of participants	12.9 percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Treatment Response at Week 96	26.7 percentage of participants	11.7 percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

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.

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Time to Treatment Failure Through 96 Weeks of Treatment	114 Days Interval 0.0 to 858.0	0 Days Interval 0.0 to 177.0

SECONDARY outcome

Timeframe: Week 48

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

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.

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment	113 Days Interval 0.0 to 395.0	0 Days Interval 0.0 to 174.0

SECONDARY outcome

Timeframe: Week 96

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment	116 Days Interval 0.0 to 858.0	0 Days Interval 0.0 to 177.0

SECONDARY outcome

Timeframe: Week 2 through Week 96 (at any point during trial)

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF	79.1 Percentage of participants	50.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 2	63.3 Percentage of participants	40.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 4	63.3 Percentage of participants	40.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 8	55.9 Percentage of participants	34.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 16	47.3 Percentage of participants	26.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 24	43.1 Percentage of participants	22.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 32

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 32	38.9 Percentage of participants	19.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 40

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 40	36.7 Percentage of participants	17.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 48	36.3 Percentage of participants	16.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 56	34.1 Percentage of participants	15.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (Viral Load >= 1 Log Drop) at Week 64	34.1 Percentage of participants	16.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 2

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 2	-1.36 Log(Copies/mL) Interval -1.87 to -0.41	-0.57 Log(Copies/mL) Interval -1.52 to 0.0

SECONDARY outcome

Timeframe: Baseline to Week 4

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 4	-1.56 Log(Copies/mL) Interval -2.15 to -0.45	-0.46 Log(Copies/mL) Interval -1.71 to 0.0

SECONDARY outcome

Timeframe: Baseline to Week 8

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 8	-1.6 Log(Copies/mL) Interval -2.43 to -0.24	-0.43 Log(Copies/mL) Interval -1.64 to -0.03

SECONDARY outcome

Timeframe: Baseline to Week 16

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 16	-1.08 Log(Copies/mL) Interval -2.5 to -0.18	-0.32 Log(Copies/mL) Interval -1.26 to -0.03

SECONDARY outcome

Timeframe: Baseline to Week 24

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 24	-0.81 Log(Copies/mL) Interval -2.5 to -0.11	-0.3 Log(Copies/mL) Interval -1.1 to 0.09

SECONDARY outcome

Timeframe: Baseline to Week 32

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 32	-0.73 Log(Copies/mL) Interval -2.42 to -0.06	-0.24 Log(Copies/mL) Interval -0.87 to 0.09

SECONDARY outcome

Timeframe: Baseline to Week 40

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 40	-0.74 Log(Copies/mL) Interval -2.43 to -0.06	-0.23 Log(Copies/mL) Interval -0.8 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 48

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 48	-0.61 Log(Copies/mL) Interval -2.34 to -0.04	-0.24 Log(Copies/mL) Interval -0.81 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 56

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 56	-0.57 Log(Copies/mL) Interval -2.32 to -0.04	-0.23 Log(Copies/mL) Interval -0.77 to 0.13

SECONDARY outcome

Timeframe: Baseline to Week 64

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 64	-0.6 Log(Copies/mL) Interval -2.29 to -0.02	-0.23 Log(Copies/mL) Interval -0.82 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 72

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 72	-0.65 Log(Copies/mL) Interval -2.29 to -0.05	-0.21 Log(Copies/mL) Interval -0.76 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 80

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 80	-0.64 Log(Copies/mL) Interval -2.24 to -0.06	-0.21 Log(Copies/mL) Interval -0.79 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 88

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 88	-0.64 Log(Copies/mL) Interval -2.28 to -0.06	-0.21 Log(Copies/mL) Interval -0.82 to 0.12

SECONDARY outcome

Timeframe: Baseline to Week 96

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Median Change From Baseline in Viral Load to Week 96	-0.6 Log(Copies/mL) Interval -2.24 to -0.01	-0.21 Log(Copies/mL) Interval -0.76 to 0.13

SECONDARY outcome

Timeframe: Baseline to Week 2

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 2 in CD4+ Cell Count	23 Cells/mm3 Standard Deviation 48	19 Cells/mm3 Standard Deviation 63

SECONDARY outcome

Timeframe: Baseline to Week 4

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 4 in CD4+ Cell Count	41 Cells/mm3 Standard Deviation 69	22 Cells/mm3 Standard Deviation 64

SECONDARY outcome

Timeframe: Baseline to Week 8

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=310 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 8 in CD4+ Cell Count	49 Cells/mm3 Standard Deviation 72	25 Cells/mm3 Standard Deviation 72

SECONDARY outcome

Timeframe: Baseline to Week 16

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 16 in CD4+ Cell Count	55 Cells/mm3 Standard Deviation 92	30 Cells/mm3 Standard Deviation 78

SECONDARY outcome

Timeframe: Baseline to Week 24

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 24 in CD4+ Cell Count	54 Cells/mm3 Standard Deviation 86	24 Cells/mm3 Standard Deviation 77

SECONDARY outcome

Timeframe: Baseline to Week 32

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 32 in CD4+ Cell Count	51 Cells/mm3 Standard Deviation 91	26 Cells/mm3 Standard Deviation 87

SECONDARY outcome

Timeframe: Baseline to Week 40

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 40 in CD4+ Cell Count	50 Cells/mm3 Standard Deviation 100	24 Cells/mm3 Standard Deviation 84

SECONDARY outcome

Timeframe: Baseline to Week 48

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 48 in CD4+ Cell Count	46 Cells/mm3 Standard Deviation 95	28 Cells/mm3 Standard Deviation 86

SECONDARY outcome

Timeframe: Baseline to Week 56

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 56 in CD4+ Cell Count	52 Cells/mm3 Standard Deviation 104	26 Cells/mm3 Standard Deviation 88

SECONDARY outcome

Timeframe: Baseline to Week 64

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 64 in CD4+ Cell Count	50 Cells/mm3 Standard Deviation 107	26 Cells/mm3 Standard Deviation 94

SECONDARY outcome

Timeframe: Baseline to Week 72

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 72 in CD4+ Cell Count	50 Cells/mm3 Standard Deviation 113	24 Cells/mm3 Standard Deviation 96

SECONDARY outcome

Timeframe: Baseline to Week 80

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 80 in CD4+ Cell Count	55 Cells/mm3 Standard Deviation 122	26 Cells/mm3 Standard Deviation 93

SECONDARY outcome

Timeframe: Baseline to Week 88

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 88 in CD4+ Cell Count	60 Cells/mm3 Standard Deviation 126	29 Cells/mm3 Standard Deviation 100

SECONDARY outcome

Timeframe: Baseline to Week 96

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Mean Change From Baseline to Week 96 in CD4+ Cell Count	60 Cells/mm3 Standard Deviation 133	28 Cells/mm3 Standard Deviation 97

SECONDARY outcome

Timeframe: after 48 weeks of treatment

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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Time to New CDC Class C Progression Event or Death.	448 Days Interval 448.0 to 448.0	284 Days Interval 284.0 to 284.0

SECONDARY outcome

Timeframe: Week 2 through Week 96 (at any point during trial)

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF	53.4 Percentage of participants	32.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 2	14.8 Percentage of participants	13.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 4	28.3 Percentage of participants	19.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 8	37.3 Percentage of participants	23.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 16	35.7 Percentage of participants	20.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 24	34.4 Percentage of participants	16.5 Percentage of participants

SECONDARY outcome

Timeframe: week 32

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 32	32.8 Percentage of participants	14.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 40

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 40	32.8 Percentage of participants	14.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 48	30.5 Percentage of participants	13.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 56	29.6 Percentage of participants	13.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 64	28.6 Percentage of participants	13.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 72	28.9 Percentage of participants	12.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 80	27.7 Percentage of participants	13.6 Percentage of participants

SECONDARY outcome

Timeframe: week 88

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 88	27.7 Percentage of participants	12.6 Percentage of participants

SECONDARY outcome

Timeframe: week 96

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

Percentage of participants with Viral Load \< 400 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 400 Copies/ml) at Week 96	26.7 Percentage of participants	11.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 2 through Week 96 (at any point during trial)

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF	37.9 Percentage of participants	20.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 2	1.9 Percentage of participants	1.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 4	6.4 Percentage of participants	4.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 8	16.1 Percentage of participants	8.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 16	23.5 Percentage of participants	9.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 24	24.8 Percentage of participants	10 Percentage of participants

SECONDARY outcome

Timeframe: Week 32

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 32	24.8 Percentage of participants	10 Percentage of participants

SECONDARY outcome

Timeframe: Week 40

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 40	23.5 Percentage of participants	8.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 48	22.5 Percentage of participants	9.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 56	21.5 Percentage of participants	10 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 64	22.8 Percentage of participants	10.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 72	21.2 Percentage of participants	11.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 80	20.6 Percentage of participants	10.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 88

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 88	22.2 Percentage of participants	9.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

Percentage of participants with Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Virologic Response (VL < 50 Copies/ml) at Week 96	20.9 Percentage of participants	9.4 Percentage of participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: 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

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

Outcome measures

Outcome measures
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=304 Participants TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=304 Participants lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Cholesterol	23.7 Percentage of participants	8.6 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Haemoglobin	1.3 Percentage of participants	0.7 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities White Blood Cell Count Increase	0 Percentage of participants	0 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities White Blood Cell Count Decrease	5.3 Percentage of participants	5.3 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Platelets	2.0 Percentage of participants	0.7 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Prothrombin Time	1.6 Percentage of participants	2.0 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Alanine Transaminase (ALT)	13.5 Percentage of participants	1.6 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Aspartate Transaminase (AST)	7.9 Percentage of participants	1.6 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities ALT or AST	15.1 Percentage of participants	2.6 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Bilirubin, Total	1.0 Percentage of participants	0.7 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Alkaline phosphatase	1.0 Percentage of participants	0 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Amylase	11.8 Percentage of participants	9.2 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Lipase	2.0 Percentage of participants	1.3 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Triglycerides	29.3 Percentage of participants	15.5 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Glucose, increase	3.3 Percentage of participants	2.0 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Glucose, decrease	0 Percentage of participants	1.0 Percentage of participants
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities Creatinine	2.0 Percentage of participants	2.3 Percentage of participants

Adverse Events

Tipranavir(TPV)/Low Dose Ritonavir(r)

Serious events: 113 serious events

Other events: 301 other events

Deaths: 0 deaths

Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)

Serious events: 61 serious events

Other events: 271 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=311 participants at risk TPV 500 mg / Ritonavir 200 mg, twice daily	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n=309 participants at risk lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Blood and lymphatic system disorders Anaemia	8.0% 25/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	1.9% 6/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Abdominal distension	8.7% 27/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	6.5% 20/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Abdominal pain	10.0% 31/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	8.1% 25/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Constipation	6.8% 21/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.2% 13/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Diarrhoea	39.5% 123/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	29.1% 90/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.1% 22/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.5% 14/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Nausea	28.3% 88/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	25.2% 78/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Gastrointestinal disorders Vomiting	18.0% 56/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	12.0% 37/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Adverse drug reaction	7.4% 23/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	6.1% 19/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Fatigue	22.8% 71/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	20.4% 63/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Injection site reaction	9.6% 30/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	10.4% 32/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Oedema peripheral	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.2% 13/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Pain	6.1% 19/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	5.5% 17/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
General disorders Pyrexia	14.8% 46/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	8.7% 27/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Bronchitis	12.2% 38/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	5.5% 17/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Candidiasis	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	6.5% 20/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Folliculitis	5.5% 17/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	3.2% 10/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Influenza	6.1% 19/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	1.6% 5/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Nasopharyngitis	10.3% 32/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	5.2% 16/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Oral candidiasis	7.4% 23/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.2% 13/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Sinusitis	13.2% 41/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	8.4% 26/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Upper respiratory tract infection	19.9% 62/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	12.0% 37/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Infections and infestations Urinary tract infection	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	2.3% 7/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Investigations Weight decreased	7.4% 23/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	6.8% 21/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Metabolism and nutrition disorders Decreased appetite	6.8% 21/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	3.2% 10/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Metabolism and nutrition disorders Hyperlipidaemia	9.3% 29/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	2.3% 7/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	0.65% 2/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Musculoskeletal and connective tissue disorders Arthralgia	11.6% 36/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	10.0% 31/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Musculoskeletal and connective tissue disorders Back pain	13.5% 42/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	7.4% 23/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Musculoskeletal and connective tissue disorders Muscle spasms	6.4% 20/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.5% 14/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Musculoskeletal and connective tissue disorders Myalgia	8.4% 26/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	5.2% 16/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Musculoskeletal and connective tissue disorders Pain in extremity	9.3% 29/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.5% 14/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Nervous system disorders Dizziness	8.7% 27/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	6.1% 19/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Nervous system disorders Headache	17.0% 53/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	11.7% 36/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Nervous system disorders Neuropathy peripheral	6.8% 21/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.5% 14/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Psychiatric disorders Anxiety	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	3.9% 12/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Psychiatric disorders Depression	11.3% 35/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	8.4% 26/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Psychiatric disorders Insomnia	10.3% 32/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	9.7% 30/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Reproductive system and breast disorders Erectile dysfunction	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	2.9% 9/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Respiratory, thoracic and mediastinal disorders Cough	18.0% 56/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	8.4% 26/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.5% 17/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.2% 13/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 19/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	3.9% 12/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Skin and subcutaneous tissue disorders Night sweats	5.8% 18/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.9% 15/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Skin and subcutaneous tissue disorders Rash	11.3% 35/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	10.7% 33/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.
Vascular disorders Hypertension	5.1% 16/311 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.	4.5% 14/309 • up to 240 weeks Adverse events were monitored throughout the study and reported in the case report form.