Trial Outcomes & Findings for Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects (NCT NCT00146328)

NCT ID: NCT00146328

Last Updated: 2014-03-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

997 participants

Primary outcome timeframe

End of Trial (>288 weeks)

Results posted on

2014-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 (Patients With Varying Degrees of Treatment Experience Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	Group 3 (Tipranavir naïve Patients) Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
Overall Study STARTED	291	255	449
Overall Study COMPLETED	150	101	158
Overall Study NOT COMPLETED	141	154	291

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Patients With Varying Degrees of Treatment Experience Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	Group 3 (Tipranavir naïve Patients) Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
Overall Study Adverse Event	39	48	79
Overall Study Protocol Violation	11	6	12
Overall Study Lost to Follow-up	7	4	7
Overall Study Withdrawal by Subject	16	16	22
Overall Study Virologic Failure/lack of efficacy	54	72	142
Overall Study Trial ended/site closed	8	2	19
Overall Study Patient decision to end	0	1	6
Overall Study Enroll into other trial	2	4	2
Overall Study Death	0	1	1
Overall Study Moved	2	0	0
Overall Study Interaction with other medication	2	0	1

Baseline Characteristics

Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.	Group 3 (Tipranavir naïve Patients) n=449 Participants A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.	Total n=995 Participants Total of all reporting groups
Age, Continuous	43.7 years STANDARD_DEVIATION 8 • n=93 Participants	45.6 years STANDARD_DEVIATION 8.2 • n=4 Participants	43.5 years STANDARD_DEVIATION 7.7 • n=27 Participants	44.1 years STANDARD_DEVIATION 8 • n=483 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	20 Participants n=4 Participants	44 Participants n=27 Participants	99 Participants n=483 Participants
Sex: Female, Male Male	256 Participants n=93 Participants	235 Participants n=4 Participants	405 Participants n=27 Participants	896 Participants n=483 Participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

Population: FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin	6 participants Interval -1.37 to -0.07	1 participants Interval -2.41 to -0.3	2 participants Interval -1.56 to -0.17

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.	20 participants	5 participants	14 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets	7 participants	9 participants	7 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time	0 participants	4 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium	1 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium	3 participants	5 participants	1 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium	2 participants	6 participants	1 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate	0 participants	8 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide	2 participants	4 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)	22 participants	24 participants	13 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)	42 participants	47 participants	27 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase	2 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase	48 participants	31 participants	24 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase	17 participants	14 participants	8 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase	12 participants	16 participants	8 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose	7 participants	10 participants	2 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total	30 participants	82 participants	34 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine	10 participants	5 participants	6 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total	1 participants	4 participants	1 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides	38 participants	75 participants	57 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid	5 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)	12 participants	48 participants	15 participants

PRIMARY outcome

Timeframe: End of Trial (>288 weeks)

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

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Number of Patients With Adverse Events Leading to Death	26 participants	10 participants	13 participants

SECONDARY outcome

Timeframe: Baseline to 192-240 week time interval

Population: FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and rolled into 1182.17

Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=291 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=255 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)	-0.5 Log 10 copies/mL Interval -1.37 to -0.07	-1.19 Log 10 copies/mL Interval -2.41 to 0.3	-0.62 Log 10 copies/mL Interval -1.56 to -0.17

SECONDARY outcome

Timeframe: Baseline to 192-240 week time interval

Population: FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4,1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed.

Change from baseline in CD4 cell count with last observation carried forward(LOCF).

Outcome measures

Outcome measures
Measure	Group 3 (Tipranavir naïve Patients) n=449 Participants Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.	Group 1 (Patients With Varying Degrees of Treatment Experience n=240 Participants Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) n=253 Participants Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Change From Baseline in CD4 Cell Count (LOCF)	21 cells/mm3 Standard Deviation 132	83 cells/mm3 Standard Deviation 178	26 cells/mm3 Standard Deviation 149

Adverse Events

Group 1 (Patients With Varying Degrees of Treatment Experience

Serious events: 100 serious events

Other events: 284 other events

Deaths: 0 deaths

Group 2 (Highly Treatment Experienced Patients)

Serious events: 91 serious events

Other events: 250 other events

Deaths: 0 deaths

Group 3 (Tipranavir naïve Patients)

Serious events: 135 serious events

Other events: 406 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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

Serious adverse events
Measure	Group 1 (Patients With Varying Degrees of Treatment Experience Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	Group 3 (Tipranavir naïve Patients) Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
Blood and lymphatic system disorders Anaemia	1.7% 5/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.9% 10/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Eosinophilia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Febrile neutropenia	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Leukopenia	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Lymphoid tissue hyperplasia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Neutropenia	0.69% 2/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.45% 2/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Thrombocytopenia	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Acute myocardial infarction	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Angina pectoris	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Angina unstable	0.69% 2/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Arrhythmia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Atrial fibrillation	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardiac arrest	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardiac failure	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardiac failure congestive	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardiac tamponade	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardio-respiratory arrest	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.45% 2/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cardiopulmonary failure	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Cor pulmonale	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Coronary artery disease	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Intracardiac thrombus	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Myocardial infarction	0.69% 2/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Right ventricular failure	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Tachycardia	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Cardiac disorders Ventricular tachycardia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Congenital, familial and genetic disorders Fanconi syndrome	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Ear and labyrinth disorders Ear pain	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Eye disorders Cataract	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Eye disorders Retinal artery embolism	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Eye disorders Retinal detachment	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Eye disorders Vision blurred	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.39% 1/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal hernia	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal pain	1.7% 5/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.78% 2/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	1.8% 8/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal pain upper	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Anal ulcer	0.34% 1/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.00% 0/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	0.22% 1/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).

Other adverse events
Measure	Group 1 (Patients With Varying Degrees of Treatment Experience Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.	Group 2 (Highly Treatment Experienced Patients) Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	Group 3 (Tipranavir naïve Patients) Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
Infections and infestations Herpes zoster	7.9% 23/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.9% 10/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.5% 20/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Influenza	10.7% 31/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.1% 18/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	6.5% 29/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Nasopharyngitis	18.6% 54/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	16.9% 43/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	13.4% 60/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Oesophageal candidiasis	2.4% 7/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	6.7% 17/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.8% 17/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Onychomycosis	6.5% 19/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.5% 9/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.9% 13/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Oral candidiasis	9.3% 27/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	13.3% 34/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	9.6% 43/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Oral herpes	5.8% 17/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.5% 14/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.0% 18/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Rhinitis	6.9% 20/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.5% 14/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.2% 10/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Sinusitis	16.5% 48/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	11.4% 29/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.3% 33/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Anaemia	7.6% 22/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	8.6% 22/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.2% 19/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Blood and lymphatic system disorders Lymphadenopathy	6.2% 18/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.3% 11/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.5% 20/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal distension	5.2% 15/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 5/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal pain	15.5% 45/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	10.2% 26/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	9.4% 42/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Abdominal pain upper	5.8% 17/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.1% 18/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.6% 16/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Constipation	7.2% 21/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.1% 13/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.9% 13/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Diarrhoea	52.2% 152/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	42.0% 107/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	28.1% 126/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Dyspepsia	7.2% 21/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	6.3% 16/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Flatulence	6.5% 19/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.1% 18/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.1% 23/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Haemorrhoids	5.2% 15/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.4% 6/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.3% 15/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Nausea	34.7% 101/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	24.3% 62/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	16.0% 72/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Gastrointestinal disorders Vomiting	19.2% 56/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	11.8% 30/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.8% 35/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Adverse drug reaction	3.1% 9/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	10.6% 27/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.6% 34/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Asthenia	9.3% 27/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	11.0% 28/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.8% 35/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Chest pain	6.2% 18/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.5% 9/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.4% 11/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Fatigue	27.5% 80/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	22.7% 58/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	10.5% 47/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Influenza like illness	5.8% 17/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.3% 11/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.2% 10/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Injection site reaction	4.1% 12/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	8.6% 22/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.3% 24/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Pain	6.2% 18/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 5/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
General disorders Pyrexia	18.2% 53/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	17.3% 44/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	13.1% 59/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Anogenital warts	5.8% 17/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	4.7% 12/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Bronchitis	14.4% 42/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	15.3% 39/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	9.4% 42/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Folliculitis	6.2% 18/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.1% 8/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.0% 9/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Gastroenteritis	4.1% 12/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.1% 18/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.8% 17/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Herpes simplex	5.2% 15/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.1% 8/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.1% 14/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Upper respiratory tract infection	26.1% 76/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	10.6% 27/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	8.0% 36/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Infections and infestations Urinary tract infection	7.9% 23/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.1% 8/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.3% 15/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Investigations Weight decreased	9.3% 27/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	7.8% 20/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.8% 26/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Metabolism and nutrition disorders Anorexia	6.5% 19/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	6.3% 16/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	6.7% 30/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Metabolism and nutrition disorders Hyperlipidaemia	10.7% 31/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	3.5% 9/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	1.6% 7/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).
Metabolism and nutrition disorders Hypertriglyceridaemia	7.9% 23/291 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	5.9% 15/255 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).	2.9% 13/449 • Up to 288 weeks. From the time patients received their first dose of TPV/r until the last patient out of the study on 26 May 2008 (for those patients who entered Trial 1182.17).