Trial Outcomes & Findings for Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI (NCT NCT00517192)

NCT ID: NCT00517192

Last Updated: 2014-05-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 48 weeks of treatment
• Results posted on: 2014-05-14

Participant Flow

Participant milestones

Measure	Tipranavir 500 mg/Ritonavir 200 mg Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral	Darunavir 600 mg/Ritonavir 100 mg Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Study STARTED	19	20
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	19	20

Reasons for withdrawal

Measure	Tipranavir 500 mg/Ritonavir 200 mg Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral	Darunavir 600 mg/Ritonavir 100 mg Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Early termination of the trial	16	18

Baseline Characteristics

Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

Baseline characteristics by cohort

Measure	Tipranavir 500 mg/Ritonavir 200 mg n=19 Participants Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral	Darunavir 600 mg/Ritonavir 100 mg n=20 Participants Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral	Total n=39 Participants Total of all reporting groups
Age, Continuous	44.3 Years STANDARD_DEVIATION 6.1 • n=5 Participants	43.1 Years STANDARD_DEVIATION 6.2 • n=7 Participants	43.6 Years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 48 weeks of treatment

Outcome measures

Outcome data not reported

Adverse Events

Tipranavir 500 mg/Ritonavir 200 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Darunavir 600 mg/Ritonavir 100 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tipranavir 500 mg/Ritonavir 200 mg n=19 participants at risk Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral	Darunavir 600 mg/Ritonavir 100 mg n=20 participants at risk Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Blood and lymphatic system disorders Neutropenia	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Infections and infestations Gangrene	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Nervous system disorders Peroneal nerve palsy	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Nervous system disorders Radiculopathy	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Vascular disorders Iliac artery thrombosis	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Vascular disorders Peripheral ischaemia	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).

Other adverse events

Measure	Tipranavir 500 mg/Ritonavir 200 mg n=19 participants at risk Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral	Darunavir 600 mg/Ritonavir 100 mg n=20 participants at risk Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Cardiac disorders Angina pectoris	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Abdominal distension	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Diarrhoea	15.8% 3/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	15.0% 3/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Nausea	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Odynophagia	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Gastrointestinal disorders Vomiting	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
General disorders Asthenia	10.5% 2/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
General disorders Fatigue	10.5% 2/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
General disorders Pyrexia	0.00% 0/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	10.0% 2/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Hepatobiliary disorders Cytolytic hepatitis	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Infections and infestations Bronchitis	10.5% 2/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Infections and infestations Subcutaneous abscess	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Infections and infestations Tracheitis	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Investigations Blood creatine phosphokinase increased	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Musculoskeletal and connective tissue disorders Osteoarthritis	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Nervous system disorders Dizziness	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Nervous system disorders Headache	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	15.0% 3/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Respiratory, thoracic and mediastinal disorders Cough	10.5% 2/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	5.0% 1/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Respiratory, thoracic and mediastinal disorders Productive cough	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).
Skin and subcutaneous tissue disorders Facial wasting	5.3% 1/19 • From the signing of the informed consent onwards through the observational phase (50 weeks).	0.00% 0/20 • From the signing of the informed consent onwards through the observational phase (50 weeks).

Additional Information

Boehringer Ingelheim Pharmaceuticals

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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