Trial Outcomes & Findings for Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2) (NCT NCT00144170)

NCT ID: NCT00144170

Last Updated: 2014-07-02

Results Overview

Patients who experienced treatment response. 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

882 participants

Primary outcome timeframe

after 48 weeks of treatment

Results posted on

2014-07-02

Participant Flow

The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.

Participant milestones

Participant milestones
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)
Overall Study STARTED	438	428
Overall Study COMPLETED	86	32
Overall Study NOT COMPLETED	352	396

Reasons for withdrawal

Reasons for withdrawal
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)
Overall Study Adverse Event	84	41
Overall Study Protocol Violation	23	16
Overall Study Lost to Follow-up	5	10
Overall Study Withdrawal by Subject	29	13
Overall Study Other reason not defined above	211	316

Baseline Characteristics

Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants	Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Total n=863 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 8.4 • n=93 Participants	42.9 years STANDARD_DEVIATION 8 • n=4 Participants	42.7 years STANDARD_DEVIATION 8.2 • n=27 Participants
Sex: Female, Male Female	84 Participants n=93 Participants	64 Participants n=4 Participants	148 Participants n=27 Participants
Sex: Female, Male Male	351 Participants n=93 Participants	364 Participants n=4 Participants	715 Participants n=27 Participants

PRIMARY outcome

Timeframe: after 48 weeks of treatment

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 48	15 percentage of participants	34.5 percentage of participants

PRIMARY outcome

Timeframe: after 48 weeks of treatment

Population: Full Analysis Set (FAS), included 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Time to Treatment Failure Through 48 Weeks of Treatment	0 Days Interval 0.0 to 112.0	112 Days Interval 0.0 to 475.0

SECONDARY outcome

Timeframe: week 2

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 2	25.9 percentage of participants	51 percentage of participants

SECONDARY outcome

Timeframe: week 4

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 4	29.9 percentage of participants	59.1 percentage of participants

SECONDARY outcome

Timeframe: week 8

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 8	24.5 Percentage of participants	54.3 Percentage of participants

SECONDARY outcome

Timeframe: week 16

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 16	19.9 percentage of participants	47.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 24	18.0 percentage of participants	40.9 percentage of participants

SECONDARY outcome

Timeframe: week 32

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 32	17.3 percentage of participants	37.2 percentage of participants

SECONDARY outcome

Timeframe: week 40

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 40	16.6 percentage of participants	36.3 percentage of participants

SECONDARY outcome

Timeframe: week 56

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 56	14.5 percentage of participants	32.6 percentage of participants

SECONDARY outcome

Timeframe: week 64

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 64	13.3 percentage of participants	31 percentage of participants

SECONDARY outcome

Timeframe: week 72

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 72	12.1 percentage of participants	30.1 percentage of participants

SECONDARY outcome

Timeframe: week 80

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 80	11.4 percentage of participants	28.5 percentage of participants

SECONDARY outcome

Timeframe: week 88

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 88	11 percentage of participants	27.8 percentage of participants

SECONDARY outcome

Timeframe: after 96 weeks of treatment

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

Patients who experienced treatment response. 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	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Treatment Response at Week 96	10 percentage of participants	26.2 percentage of participants

SECONDARY outcome

Timeframe: after 96 weeks of treatment

Population: Full Analysis Set (FAS), included 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Time to Treatment Failure Through 96 Weeks of Treatment	0 Days Interval 0.0 to 112.0	115 Days Interval 0.0 to 811.0

SECONDARY outcome

Timeframe: after 48 weeks of treatment

Population: Full Analysis Set (FAS), included 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 where the Log(baseline viral load)-Log(on-treatment viral load)\>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)\<1.

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment	0 Days Interval 0.0 to 112.0	117 Days Interval 0.0 to 475.0

SECONDARY outcome

Timeframe: after 96 weeks of treatment

Population: Full Analysis Set (FAS), included 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 where the Log(baseline viral load)-Log(on-treatment viral load)\>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)\<1.

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment	0 Days Interval 0.0 to 112.0	117 Days Interval 0.0 to 756.0

SECONDARY outcome

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

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response	48.6 Percentage of participants	75.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 2	36 Percentage of participants	60.5 Percentage of participants

SECONDARY outcome

Timeframe: week 4

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 4	33.4 Percentage of participants	62.3 Percentage of participants

SECONDARY outcome

Timeframe: week 8

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 8	26.6 Percentage of participants	56.3 Percentage of participants

SECONDARY outcome

Timeframe: week 16

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 16	20.8 Percentage of participants	47.1 Percentage of participants

SECONDARY outcome

Timeframe: week 24

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 24	19.2 Percentage of participants	42.8 Percentage of participants

SECONDARY outcome

Timeframe: week 32

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 32	19.4 Percentage of participants	38.6 Percentage of participants

SECONDARY outcome

Timeframe: week 40

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 40	17.3 Percentage of participants	37 Percentage of participants

SECONDARY outcome

Timeframe: week 48

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 48	16.6 Percentage of participants	36.8 Percentage of participants

SECONDARY outcome

Timeframe: week 56

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 56	15.2 Percentage of participants	35.2 Percentage of participants

SECONDARY outcome

Timeframe: week 64

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 64	14 Percentage of participants	33.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 72	13.8 Percentage of participants	32.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 80	13.6 Percentage of participants	32.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 88

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 88	12.1 Percentage of participants	31 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 96	11.4 Percentage of participants	30.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 2

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 2)	-0.56 Log(Copies/mL) Interval -1.28 to 0.0	-1.27 Log(Copies/mL) Interval -1.78 to -0.55

SECONDARY outcome

Timeframe: Baseline to Week 4

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 4)	-0.42 Log(Copies/mL) Interval -1.35 to 0.0	-1.47 Log(Copies/mL) Interval -2.03 to -0.4

SECONDARY outcome

Timeframe: Baseline to Week 8

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 8)	-0.33 Log(Copies/mL) Interval -1.23 to 0.0	-1.4 Log(Copies/mL) Interval -2.25 to -0.22

SECONDARY outcome

Timeframe: Baseline to Week 16

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 16)	-0.3 Log(Copies/mL) Interval -0.93 to -0.02	-1.03 Log(Copies/mL) Interval -2.35 to -0.17

SECONDARY outcome

Timeframe: Baseline to Week 24

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 24)	-0.21 Log(Copies/mL) Interval -0.86 to 0.06	-0.69 Log(Copies/mL) Interval -2.28 to -0.11

SECONDARY outcome

Timeframe: Baseline to Week 32

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 32)	-0.24 Log(Copies/mL) Interval -0.84 to 0.06	-0.63 Log(Copies/mL) Interval -2.29 to -0.09

SECONDARY outcome

Timeframe: Baseline to Week 40

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 40)	-0.2 Log(Copies/mL) Interval -0.73 to 0.1	-0.65 Log(Copies/mL) Interval -2.27 to -0.07

SECONDARY outcome

Timeframe: Baseline to Week 48

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 48)	-0.2 Log(Copies/mL) Interval -0.75 to 0.11	-0.65 Log(Copies/mL) Interval -2.17 to -0.07

SECONDARY outcome

Timeframe: Baseline to Week 56

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 56)	-0.22 Log(Copies/mL) Interval -0.74 to 0.11	-0.64 Log(Copies/mL) Interval -2.16 to -0.07

SECONDARY outcome

Timeframe: Baseline to Week 64

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 64)	-0.21 Log(Copies/mL) Interval -0.71 to 0.12	-0.63 Log(Copies/mL) Interval -2.12 to -0.07

SECONDARY outcome

Timeframe: Baseline to Week 72

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 72)	-0.2 Log(Copies/mL) Interval -0.7 to 0.11	-0.52 Log(Copies/mL) Interval -2.14 to -0.05

SECONDARY outcome

Timeframe: Baseline to Week 80

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 80)	-0.2 Log(Copies/mL) Interval -0.72 to 0.11	-0.55 Log(Copies/mL) Interval -2.14 to -0.06

SECONDARY outcome

Timeframe: Baseline to Week 88

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 88)	-0.2 Log(Copies/mL) Interval -0.7 to 0.11	-0.56 Log(Copies/mL) Interval -2.12 to -0.03

SECONDARY outcome

Timeframe: Baseline to Week 96

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

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Median Change From Baseline in Viral Load (Week 96)	-0.2 Log(Copies/mL) Interval -0.67 to 0.11	-0.56 Log(Copies/mL) Interval -2.14 to -0.05

SECONDARY outcome

Timeframe: Week 40

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 40	15 Percentage of participants	31.5 Percentage of participants

SECONDARY outcome

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

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks	25.7 Percentage of participants	52.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 2	8.2 Percentage of participants	14.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 4	15.2 Percentage of participants	26.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 8	17.5 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 16	17.5 Percentage of participants	35.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 24	15.4 Percentage of participants	32.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 32

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 32	16.1 Percentage of participants	32.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 48	13.6 Percentage of participants	30.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 56	12.4 Percentage of participants	30.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 64	12.1 Percentage of participants	28.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 72	11.4 Percentage of participants	28 Percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 80	11 Percentage of participants	28.7 Percentage of participants

SECONDARY outcome

Timeframe: week 88

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 88	11.2 Percentage of participants	27.8 Percentage of participants

SECONDARY outcome

Timeframe: week 96

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

Virologic response defined as Viral Load\<400 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 96	10.3 Percentage of participants	27.1 Percentage of participants

SECONDARY outcome

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

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response	16.8 Percentage of participants	36.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 2

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 2	1.4 Percentage of participants	0.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 4	3.5 Percentage of participants	4.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 8	6.8 Percentage of participants	11 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 16	10.5 Percentage of participants	20.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Viral Load \< 50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 24	11.9 Percentage of participants	21.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 32

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 32	12.1 Percentage of participants	22.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 40

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 40	11.9 Percentage of participants	22.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 48	10.5 Percentage of participants	22.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 56	8.9 Percentage of participants	22.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 64	8.2 Percentage of participants	21.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 72	8.2 Percentage of participants	21.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 80

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 80	8.9 Percentage of participants	21.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 88

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 88	8.9 Percentage of participants	20.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

Virologic response defined as Viral Load\<50 copies/mL

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Virologic Response at Week 96	8.9 Percentage of participants	20 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 2)	13 Cells/mm3 Standard Deviation 56	26 Cells/mm3 Standard Deviation 65

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 4)	19 Cells/mm3 Standard Deviation 64	39 Cells/mm3 Standard Deviation 77

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 8)	25 Cells/mm3 Standard Deviation 76	52 Cells/mm3 Standard Deviation 85

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 16)	25 Cells/mm3 Standard Deviation 77	57 Cells/mm3 Standard Deviation 90

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 24)	21 Cells/mm3 Standard Deviation 81	51 Cells/mm3 Standard Deviation 97

SECONDARY outcome

Timeframe: Baseline to Week 32

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 32)	17 Cells/mm3 Standard Deviation 87	46 Cells/mm3 Standard Deviation 102

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 40)	19 Cells/mm3 Standard Deviation 87	47 Cells/mm3 Standard Deviation 99

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 48)	16 Cells/mm3 Standard Deviation 92	43 Cells/mm3 Standard Deviation 109

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 56)	16 Cells/mm3 Standard Deviation 95	39 Cells/mm3 Standard Deviation 113

SECONDARY outcome

Timeframe: Baseline to Week 64

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 64)	13 Cells/mm3 Standard Deviation 92	42 Cells/mm3 Standard Deviation 125

SECONDARY outcome

Timeframe: Baseline to Week 72

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 72)	18 Cells/mm3 Standard Deviation 105	42 Cells/mm3 Standard Deviation 129

SECONDARY outcome

Timeframe: Baseline to Week 80

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 80)	19 Cells/mm3 Standard Deviation 112	39 Cells/mm3 Standard Deviation 125

SECONDARY outcome

Timeframe: Baseline to Week 88

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 88)	19 Cells/mm3 Standard Deviation 109	41 Cells/mm3 Standard Deviation 138

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=418 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=430 Participants
Mean Change From Baseline in CD4+ Cell Count (Week 96)	20 Cells/mm3 Standard Deviation 111	41 Cells/mm3 Standard Deviation 132

SECONDARY outcome

Timeframe: up to 75 weeks of treatment

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

Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition. The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.

Outcome measures

Outcome measures
Measure	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 Participants	Tipranavir(TPV)/Low Dose Ritonavir(r) n=435 Participants
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.	332 Days Interval 332.0 to 332.0	528 Days Interval 528.0 to 528.0

Adverse Events

Tipranavir(TPV)/Low Dose Ritonavir(r)

Serious events: 123 serious events

Other events: 359 other events

Deaths: 0 deaths

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

Serious events: 89 serious events

Other events: 270 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=438 participants at risk	Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 participants at risk
Gastrointestinal disorders Vomiting	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.93% 4/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Anaemia	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Neutropenia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Acute coronary syndrome	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Acute myocardial infarction	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Angina pectoris	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Angina unstable	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Cardiac arrest	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Cardiac tamponade	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Myocardial infarction	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Pericardial effusion	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Cardiac disorders Ventricular fibrillation	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Ear and labyrinth disorders Ear pain	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Eye disorders Blindness	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Eye disorders Chorioretinitis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Eye disorders Retinal detachment	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Eye disorders Retinitis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Abdominal pain	1.4% 6/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Anal fistula	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Anal ulcer	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Ascites	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Colitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Diarrhoea	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Dysphagia	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Enterocolitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Haemorrhoids	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Ileus	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Inguinal hernia	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Intestinal haemorrhage	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Intestinal perforation	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Irritable bowel syndrome	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Megacolon	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Odynophagia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Pancreatitis	1.1% 5/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Pancreatitis acute	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Peptic ulcer	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Tooth disorder	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Asthenia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Chest pain	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Chills	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Death	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Gait disturbance	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders General physical health deterioration	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Local swelling	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Mucosal inflammation	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Multi-organ failure	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Oedema	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Oedema peripheral	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Pain	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Pyrexia	3.0% 13/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	2.1% 9/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Sudden death	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Cholangitis chronic	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Cholecystitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Gallbladder disorder	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Gallbladder polyp	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Hepatic cirrhosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Hepatic failure	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Hepatic steatosis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Hepatitis toxic	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Hyperbilirubinaemia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Hepatobiliary disorders Portal hypertension	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Immune system disorders Drug hypersensitivity	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations AIDS encephalopathy	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Abdominal abscess	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Acarodermatitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Actinomycotic pulmonary infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Acute sinusitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Amoebic dysentery	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Anal abscess	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Anal infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Anogenital warts	0.91% 4/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Appendiceal abscess	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Appendicitis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Arthritis infective	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Atypical mycobacterial infection	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Bacteraemia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Bronchitis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Campylobacter intestinal infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cerebral toxoplasmosis	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.93% 4/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cryptosporidiosis infection	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cyclosporidium infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cytomegalovirus chorioretinitis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cytomegalovirus colitis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Cytomegalovirus infection	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Diarrhoea infectious	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Disseminated cryptococcosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Endocarditis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Erysipelas	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Fungal oesophagitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Gastroenteritis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.93% 4/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Gastroenteritis cryptosporidial	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations HIV infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Haemophilus sepsis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Helicobacter sepsis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Herpes oesophagitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Herpes ophthalmic	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Herpes zoster	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Histoplasmosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Isosporiasis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Malaria	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Nocardiosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Oesophageal candidiasis	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Orchitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Osteomyelitis chronic	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Parotitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pneumocystis jiroveci infection	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pneumocystis jiroveci pneumonia	0.91% 4/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pneumonia	2.5% 11/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pneumonia bacterial	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pneumonia pneumococcal	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Postoperative wound infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Progressive multifocal leukoencephalopathy	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pulmonary tuberculosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Pyelonephritis acute	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Respiratory tract infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Salmonella sepsis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Salmonellosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Sepsis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Septic shock	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Sinusitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Skin infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Staphylococcal sepsis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Subcutaneous abscess	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Syphilis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Tuberculosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Urinary tract infection	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Urosepsis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Visceral leishmaniasis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Wound infection	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Accident at home	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Coronary artery restenosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Humerus fracture	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Injury	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Limb injury	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Lower limb fracture	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Overdose	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Road traffic accident	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Skin laceration	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Injury, poisoning and procedural complications Tibia fracture	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Alanine aminotransferase increased	0.91% 4/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Aspartate aminotransferase increased	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Blood creatinine increased	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Blood glucose increased	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Blood lactic acid increased	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Blood triglycerides increased	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Electrocardiogram change	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Gamma-glutamyltransferase increased	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Liver function test abnormal	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Transaminases increased	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Weight decreased	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Acidosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Cachexia	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Dehydration	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Lactic acidosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Metabolic acidosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Mitochondrial toxicity	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Obesity	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Polydipsia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Back pain	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer recurrent	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer stage 0	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease mixed cellularity stage unspecified	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent cancer	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine carcinoma in situ	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Balance disorder	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Central nervous system lesion	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Cerebral ataxia	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Cerebral haematoma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Cerebral ischaemia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Cerebrovascular accident	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Cervical root pain	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Coma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Convulsion	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Dizziness	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Embolic cerebral infarction	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Encephalitis	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Headache	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.70% 3/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Hemiparesis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Intracranial pressure increased	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Intraventricular haemorrhage	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Ischaemic stroke	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Lacunar infarction	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Nervous system disorder	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Neuropathy peripheral	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Neurotoxicity	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Parkinsonism	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Polyneuropathy	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Syncope vasovagal	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Tremor	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Anxiety	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Depression	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Depression suicidal	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Disorientation	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Hallucination	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Suicide attempt	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Calculus bladder	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Dysuria	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Glomerulonephritis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Hydronephrosis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Nephrogenic diabetes insipidus	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Nephrolithiasis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Nephrotic syndrome	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Oliguria	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Polyuria	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Renal colic	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Renal failure	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Renal and urinary disorders Renal failure acute	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Reproductive system and breast disorders Cervical dysplasia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Reproductive system and breast disorders Ovarian cyst	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Reproductive system and breast disorders Ovarian mass	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.68% 3/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary cavitation	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.91% 4/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Vocal cord thickening	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.46% 2/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Rash	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Surgical and medical procedures Eventration procedure	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Surgical and medical procedures Hip arthroplasty	0.00% 0/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.23% 1/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Vascular disorders Hypertension	0.23% 1/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.00% 0/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

Other adverse events

Other adverse events
Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n=438 participants at risk	Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n=428 participants at risk
Gastrointestinal disorders Abdominal pain	11.4% 50/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	6.8% 29/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Abdominal pain upper	8.0% 35/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	5.8% 25/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Diarrhoea	33.8% 148/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	23.4% 100/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Dyspepsia	6.2% 27/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.2% 18/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Flatulence	6.2% 27/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.2% 18/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Nausea	19.9% 87/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	9.8% 42/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Gastrointestinal disorders Vomiting	13.0% 57/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	7.9% 34/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Adverse drug reaction	5.0% 22/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	0.47% 2/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Asthenia	7.8% 34/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	6.1% 26/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Fatigue	8.9% 39/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	5.6% 24/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
General disorders Pyrexia	14.8% 65/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	9.1% 39/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Bronchitis	13.2% 58/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	5.4% 23/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Influenza	11.0% 48/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	8.2% 35/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Nasopharyngitis	16.9% 74/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	8.9% 38/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Oral candidiasis	9.6% 42/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	7.2% 31/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Sinusitis	8.2% 36/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.7% 16/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Infections and infestations Urinary tract infection	5.9% 26/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	1.4% 6/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Investigations Weight decreased	7.3% 32/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.3% 14/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Metabolism and nutrition disorders Hypertriglyceridaemia	7.3% 32/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.7% 20/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 24/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.7% 20/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Back pain	8.7% 38/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.0% 17/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 26/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	4.4% 19/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	5.5% 24/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.0% 13/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Dizziness	8.9% 39/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.5% 15/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Nervous system disorders Headache	17.8% 78/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	7.9% 34/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Depression	7.1% 31/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.3% 14/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Psychiatric disorders Insomnia	6.2% 27/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	6.1% 26/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Cough	10.7% 47/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	6.5% 28/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Pruritus	7.5% 33/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	3.7% 16/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Skin and subcutaneous tissue disorders Rash	8.2% 36/438 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.	5.4% 23/428 • 240 weeks 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

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