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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00146328
• Collaborator: (none)
• Enrollment: 997
• Locations: 233
• Arms: 3
• Patients Per Site: 4.3

Study Details

Study Description

Brief Summary

The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tipranavir	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 997 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
• Study Start Date: Apr 1, 2001
• Actual Primary Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Patients With Varying Degrees of Tipranavir Treatment Experience	Drug: Tipranavir
Experimental: Group 2 Highly Tipranavir Treatment Experienced Patients	Drug: Tipranavir
Experimental: Group 3 Tipranavir Treatment Naive Patients	Drug: Tipranavir

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin [End of Trial (>288 weeks)]

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

2. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct. [End of Trial (>288 weeks)]

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

3. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets [End of Trial (>288 weeks)]

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

4. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time [End of Trial (>288 weeks)]

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

5. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium [End of Trial (>288 weeks)]

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

6. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium [End of Trial (>288 weeks)]

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

7. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium [End of Trial (>288 weeks)]

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

8. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate [End of Trial (>288 weeks)]

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

9. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide [End of Trial (>288 weeks)]

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

10. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT) [End of Trial (>288 weeks)]

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

11. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT) [End of Trial (>288 weeks)]

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

12. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase [End of Trial (>288 weeks)]

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

13. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase [End of Trial (>288 weeks)]

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

14. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase [End of Trial (>288 weeks)]

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

15. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase [End of Trial (>288 weeks)]

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

16. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose [End of Trial (>288 weeks)]

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

17. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total [End of Trial (>288 weeks)]

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

18. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine [End of Trial (>288 weeks)]

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

19. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total [End of Trial (>288 weeks)]

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

20. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides [End of Trial (>288 weeks)]

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

21. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid [End of Trial (>288 weeks)]

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

22. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin [End of Trial (>288 weeks)]

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

23. Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL) [End of Trial (>288 weeks)]

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

24. Number of Patients With Adverse Events Leading to Death [End of Trial (>288 weeks)]

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

Secondary Outcome Measures

1. Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF) [Baseline to 192-240 week time interval]

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

2. Change From Baseline in CD4 Cell Count (LOCF) [Baseline to 192-240 week time interval]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA

1. Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.

2. All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visits.

3. Male and female subjects 18 years and over.

4. Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to study entry.

5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).

6. Acceptable screening laboratory values that indicate adequate baseline organ function.

Laboratory values are considered to be acceptable if the following apply:

• Total Cholesterol ≤400 mg/dl (<Common Toxicity Criteria (CTC) Grade 2).

• Total Triglycerides ≤750 mg/dl (<Division of AIDS (DAIDS) Grade 2).

• Alanine aminotransferase (ALT) ≤3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) ≤2.5x ULN (<DAIDS Grade 1).

• Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable.

• Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.

• All other laboratory test values ≤DAIDS Grade 1.

EXCLUSION CRITERIA

1. Female subjects who are of reproductive potential who:

• Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit.

• Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms).

• Are breast-feeding.

1. Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to health and to protocol adherence.

2. Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol.

3. History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir/ritonavir to the subject.

4. Active use of any of the following:

• Investigational HIV-1 vaccines.

• Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial.

• Medications excluded during the trial period (see Section 4.2).

• Herbal medications (e.g., St. John's Wort).

1. Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator.

If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer Ingelheim Clinical Monitor or Local Clinical Monitor.

1. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values.

2. Hypersensitivity to tipranavir or ritonavir.

3. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1182.17.39 MDS Pharma Services	Phoenix	Arizona	United States
2	1182.17.75 Boehringer Ingelheim Investigational Site	Phoenix	Arizona	United States
3	1182.17.89 Boehringer Ingelheim Investigational Site	Berkeley	California	United States
4	1182.17.60 Boehringer Ingelheim Investigational Site	Fountain Valley	California	United States
5	1182.17.106 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
6	1182.17.15 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
7	1182.17.40 Tower ID Medical	Los Angeles	California	United States
8	1182.17.46 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
9	1182.17.47 University of Southern California	Los Angeles	California	United States
10	1182.17.73 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
11	1182.17.114 Boehringer Ingelheim Investigational Site	San Diego	California	United States
12	1182.17.128 Boehringer Ingelheim Investigational Site	San Diego	California	United States
13	1182.17.37 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
14	1182.17.58 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
15	1182.17.96 Boehringer Ingelheim Investigational Site	San Francisco	California	United States
16	1182.17.87 Boehringer Ingelheim Investigational Site	Norwalk	Connecticut	United States
17	1182.17.112 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
18	1182.17.43 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
19	1182.17.65 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
20	1182.17.126 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida	United States
21	1182.17.8 Boehringer Ingelheim Investigational Site	Fort Myers	Florida	United States
22	1182.17.131 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
23	1182.17.22 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
24	1182.17.64 Boehringer Ingelheim Investigational Site	Orlando	Florida	United States
25	1182.17.129 Boehringer Ingelheim Investigational Site	Sarasota	Florida	United States
26	1182.17.51 Boehringer Ingelheim Investigational Site	South Miami	Florida	United States
27	1182.17.125 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
28	1182.17.132 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
29	1182.17.76 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
30	1182.17.52 Boehringer Ingelheim Investigational Site	Vero Beach	Florida	United States
31	1182.17.77 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
32	1182.17.69 Boehringer Ingelheim Investigational Site	Macon	Georgia	United States
33	1182.17.136 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
34	1182.17.70 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
35	1182.17.36 Boehringer Ingelheim Investigational Site	Evanston	Illinois	United States
36	1182.17.1 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
37	1182.17.32 University of Kansas School of Medicine - Wichita	Wichita	Kansas	United States
38	1182.17.102 Boehringer Ingelheim Investigational Site	Lexington	Kentucky	United States
39	1182.17.21 Boehringer Ingelheim Investigational Site	Louisville	Kentucky	United States
40	1182.17.30 Boehringer Ingelheim Investigational Site	Portland	Maine	United States
41	1182.17.67 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
42	1182.17.86 Boehringer Ingelheim Investigational Site	Bethesda	Maryland	United States
43	1182.17.111 Boehringer Ingelheim Investigational Site	Boston	Massachusetts	United States
44	1182.17.63 Boehringer Ingelheim Investigational Site	Boston	Massachusetts	United States
45	1182.17.74 Boehringer Ingelheim Investigational Site	Springfield	Massachusetts	United States
46	1182.17.4 Boehringer Ingelheim Investigational Site	Ann Arbor	Michigan	United States
47	1182.17.115 Boehringer Ingelheim Investigational Site	Detroit	Michigan	United States
48	1182.17.6 Boehringer Ingelheim Investigational Site	Detroit	Michigan	United States
49	1182.17.62 Boehringer Ingelheim Investigational Site	Kansas City	Missouri	United States
50	1182.17.59 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada	United States
51	1182.17.118 Early Intervention Program (EIP) Clinic	Camden	New Jersey	United States
52	1182.17.93 Boehringer Ingelheim Investigational Site	East Orange	New Jersey	United States
53	1182.17.24 Hackensack University Medical Center	Hackensack	New Jersey	United States
54	1182.17.34 ID Care, Inc.	Hillsborough	New Jersey	United States
55	1182.17.50 Boehringer Ingelheim Investigational Site	Santa Fe	New Mexico	United States
56	1182.17.79 Boehringer Ingelheim Investigational Site	Albany	New York	United States
57	1182.17.103 Boehringer Ingelheim Investigational Site	Mount Vernon	New York	United States
58	1182.17.105 Pollari Medical Group	New York	New York	United States
59	1182.17.130 Boehringer Ingelheim Investigational Site	New York	New York	United States
60	1182.17.3 Division of Infectious Diseases	New York	New York	United States
61	1182.17.42 Beth Israel Medical Center	New York	New York	United States
62	1182.17.5 Boehringer Ingelheim Investigational Site	New York	New York	United States
63	1182.17.7 Boehringer Ingelheim Investigational Site	New York	New York	United States
64	1182.17.94 Boehringer Ingelheim Investigational Site	New York	New York	United States
65	1182.17.135 Boehringer Ingelheim Investigational Site	Rochester	New York	United States
66	1182.17.31 Boehringer Ingelheim Investigational Site	Stony Brook	New York	United States
67	1182.17.53 Boehringer Ingelheim Investigational Site	Durham	North Carolina	United States
68	1182.17.54 Boehringer Ingelheim Investigational Site	Huntersville	North Carolina	United States
69	1182.17.134 Summa Health System	Akron	Ohio	United States
70	1182.17.95 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
71	1182.17.26 Boehringer Ingelheim Investigational Site	Columbus	Ohio	United States
72	1182.17.9 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma	United States
73	1182.17.110 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania	United States
74	1182.17.99 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania	United States
75	1182.17.23 Boehringer Ingelheim Investigational Site	Columbia	South Carolina	United States
76	1182.17.11 Boehringer Ingelheim Investigational Site	Memphis	Tennessee	United States
77	1182.17.18 Vanderbilt AIDS Clinical Trials Center	Nashville	Tennessee	United States
78	1182.17.116 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
79	1182.17.142 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
80	1182.17.16 Nelson-Tebedo Clinic	Dallas	Texas	United States
81	1182.17.122 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
82	1182.17.68 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
83	1182.17.97 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
84	1182.17.10 Boehringer Ingelheim Investigational Site	Annandale	Virginia	United States
85	1182.17.92 Boehringer Ingelheim Investigational Site	Tacoma	Washington	United States
86	1182.17.100 Boehringer Ingelheim Investigational Site	Milwaukee	Wisconsin	United States
87	1182.17.5401 Fundacion Huesped	Capital Federal		Argentina
88	1182.17.5402 Funcei	Capital Federal		Argentina
89	1182.17.5403 consultorio externo "PETS"	Capital Federal		Argentina
90	1182.17.5404 Infectología	Capital Federal		Argentina
91	1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)	Capital Federal		Argentina
92	1182.17.5406 Pabellón de Clínicas 2° Piso	Capital Federal		Argentina
93	1182.17.401 St. Vincent's Hospital	Darlinghurst	New South Wales	Australia
94	1182.17.402 Taylor Square Private Clinic	Darlinghurst	New South Wales	Australia
95	1182.17.405 AIDS Research Initiative	DarlingHurst	New South Wales	Australia
96	1182.17.407 Holdsworth House General Practice	Darlinghurst	New South Wales	Australia
97	1182.17.408 407 Doctors Pty Ltd.	Darlinghurst	New South Wales	Australia
98	1182.17.403 Albion Street Clinic	Surry Hills	New South Wales	Australia
99	1182.17.404 Alfred Hospital	Melbourne	Victoria	Australia
100	1182.17.4301 Boehringer Ingelheim Investigational Site	Wien		Austria
101	1182.17.3209 Instituut Tropische Geneeskunde	Antwerpen		Belgium
102	1182.17.3201 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
103	1182.17.3202 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
104	1182.17.3207 Boehringer Ingelheim Investigational Site	Gent		Belgium
105	1182.17.3210 Centre Hospitalier de Luxembourg	Luxembourg		Belgium
106	1182.17.5511 Universidade Federal da Bahia	Canela - Salvador - BA		Brazil
107	1182.17.5508 I.I. Emilio Ribas	Cerqueira César, São Paulo - SP		Brazil
108	1182.17.5509 (Unidade de Testes Terapêuticos)	Cidade Nova - Rio de Janeiro - RJ		Brazil
109	1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas	Manguinhos - Rio de Janeiro - RJ		Brazil
110	1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC	Mercês - Curitiba - PR		Brazil
111	1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde	Nova Iguaçu - Rio de Janeiro - RJ		Brazil
112	1182.17.5501 Hospital Dia	Sacoma - São Paulo - SP		Brazil
113	1182.17.5503 Instituto de Infectologia Emílio Ribas	São Paulo - SP		Brazil
114	1182.17.5504 Enfermaria de MI	São Paulo - SP		Brazil
115	1182.17.5510 Casa de AIDS	São Paulo, SP		Brazil
116	1182.17.5506 Centro de Referência e Treinamento - DST/AIDS	Vila Mariana, Sao Paulo - SP		Brazil
117	1182.17.902 Downtown Infectious Diseases Clinic	Vancouver	British Columbia	Canada
118	1182.17.913 McMaster University Medical Centre	Hamilton	Ontario	Canada
119	1182.17.901 Division of Infectious Diseases	Ottawa	Ontario	Canada
120	1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.	Toronto	Ontario	Canada
121	1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital	Toronto	Ontario	Canada
122	1182.17.907 University Health Network - Toronto General Hospital	Toronto	Ontario	Canada
123	1182.17.910 Sunnybrook & Women's College Health Science Centre	Toronto	Ontario	Canada
124	1182.17.914 Montreal General Hospital - McGill University Health Centre	Monteal	Quebec	Canada
125	1182.17.903 Montreal Chest Institute, McGill University Health Centre	Montreal	Quebec	Canada
126	1182.17.904 Clinique Medicale Du Quartier Latin	Montreal	Quebec	Canada
127	1182.17.915 Clinique medicale l'Actuel	Montreal	Quebec	Canada
128	1182.17.4505 Boehringer Ingelheim Investigational Site	Aarhus N		Denmark
129	1182.17.4501 Boehringer Ingelheim Investigational Site	Copenhagen Ø		Denmark
130	1182.17.4502 Boehringer Ingelheim Investigational Site	Hvidovre		Denmark
131	1182.17.4504 Boehringer Ingelheim Investigational Site	Odense		Denmark
132	1182.17.33011 Hôpital Pellegrin	Bordeaux cedex		France
133	1182.17.33019 Hôpital Saint André	Bordeaux cedex		France
134	1182.17.33020 Hôpital Côte de Nacre	Caen cedex 5		France
135	1182.17.33007 Hôpital Antoine Beclere	Clamart		France
136	1182.17.33008 Hôpital de l'Hôtel Dieu	Lyon cedex 2		France
137	1182.17.33023 Hôpital Edouard Herriot	Lyon cedex 3		France
138	1182.17.33012 Hôpital de la Conception	Marseille cedex 5		France
139	1182.17.33013 Hôpital Sainte Marguerite	Marseille cedex 9		France
140	1182.17.00336 Hôpital Hôtel Dieu	Nantes cedex 1		France
141	1182.17.33010 Hôpital de l'Archet	Nice cedex 3		France
142	1182.17.33024 Groupe Hospitalier Cochin	Paris cedex 14		France
143	1182.17.33022 Hôpital Européen Georges Pompidou	Paris cedex 15		France
144	1182.17.00335 Hôpital Bichat Claude Bernard	Paris cedex 18		France
145	1182.17.00331 Hôpital Tenon	Paris cedex 20		France
146	1182.17.00333 Hôpital Saint Louis	Paris		France
147	1182.17.00334 Hôpital de la Pitié Salpêtrière	Paris		France
148	1182.17.33014 Hôpital Saint Antoine	Paris		France
149	1182.17.33018 Hôpital de Pontchaillou	Rennes cedex 9		France
150	1182.17.33016 Hôpital Civil	Strasbourg cedex		France
151	1182.17.00332 Hôpital du Chalucet	Toulon		France
152	1182.17.33017 Hôpital Brabois Adultes	Vandoeuvre les Nancy		France
153	1182.17.33021 Hôpital Paul Brousse	Villejuif cedex		France
154	1182.17.4911 Arzt für Innere Medizin	Aachen		Germany
155	1182.17.4901 Epimed GmbH c/o	Berlin		Germany
156	1182.17.4902 Charite, Campus Virchow-Klinikum	Berlin		Germany
157	1182.17.4918 Rheinische Friedrich-Wilhelm-Universität	Bonn		Germany
158	1182.17.4906 ID-Ambulanz Klinikum Dortmund	Dortmund		Germany
159	1182.17.4912 Universitätsklinikum Düsseldorf	Düsseldorf		Germany
160	1182.17.4914 Arzt für Innere Medizin	Düsseldorf		Germany
161	1182.17.4908 Universitätskliniken Erlangen	Erlangen		Germany
162	1182.17.4904 Universitätsklinikum Essen	Essen		Germany
163	1182.17.4924 Klinikum der J. W.-Goethe-Universität	Frankfurt/Main		Germany
164	1182.17.4930 Universitätsklinikum Freiburg	Freiburg/Breisgau		Germany
165	1182.17.4928 Facharzt für Innere Medizin/Rheumatologie	Freiburg		Germany
166	1182.17.4916 Medizinisches Versorgungszentrum Hamburg	Hamburg		Germany
167	1182.17.4929 Universitätsklinikum Eppendorf	Hamburg		Germany
168	1182.17.4931 IPM Study Center GmbH	Hamburg		Germany
169	1182.17.4920 Abteilung Klinische Immunologie	Hannover		Germany
170	1182.17.4909 Universitätsklinikum Heidelberg	Heidelberg		Germany
171	1182.17.4905 Universitätsklinik Köln	Köln		Germany
172	1182.17.4926 Internist	Köln		Germany
173	1182.17.4923 Facharzt für Innere Medizin,	Mannheim		Germany
174	1182.17.4907 Medizinische Poliklinik	München		Germany
175	1182.17.4910 MUC Research GmbH	München		Germany
176	1182.17.4915 Klinium Natruper Holz	Osnabrück		Germany
177	1182.17.4921 Arzt für Allgemeinmedizin	Stuttgart		Germany
178	1182.17.3001 Boehringer Ingelheim Investigational Site	Athens		Greece
179	1182.17.3002 Boehringer Ingelheim Investigational Site	Athens		Greece
180	1182.17.3003 Boehringer Ingelheim Investigational Site	Athens		Greece
181	1182.17.3004 Boehringer Ingelheim Investigational Site	Athens		Greece
182	1182.17.3007 Boehringer Ingelheim Investigational Site	Athens		Greece
183	1182.17.3010 Boehringer Ingelheim Investigational Site	Patras		Greece
184	1182.17.3009 Boehringer Ingelheim Investigational Site	Thessaloniki		Greece
185	1182.17.0409 Ospedale Santa Maria Annunziata	Antella (fi)		Italy
186	1182.17.0413 Ospedale di Circolo di Busto	Busto Arsizio (va)		Italy
187	1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna	Ferrara		Italy
188	1182.17.0397 Ospedale San Martino	Genova		Italy
189	1182.17.0412 S.C. Malattie Infettive	Genova		Italy
190	1182.17.0411 Presidio Ospedaliero "A. Manzoni"	Lecco		Italy
191	1182.17.0389 Reparto Malattie Infettive	Macerata		Italy
192	1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor	Milano		Italy
193	1182.17.0386 Policlinico Universitario	Modena		Italy
194	1182.17.0388 Ospedale A. Cotugno	Napoli		Italy
195	1182.17.0385 IRCCS Policlinico San Matteo	Pavia		Italy
196	1182.17.0394 IRCCS Policlinico San Matteo	Pavia		Italy
197	1182.17.0395 Azienda Policlinico Umberto I	Roma		Italy
198	1182.17.0419 I Cattedra Malattie Infettive	Roma		Italy
199	1182.17.0387 Ospedale Amedeo di Savoia	Torino		Italy
200	1182.17.0398 Ospedale Amedeo di Savoia	Torino		Italy
201	1182.17.0415 U.O.A. Malattie Infettive B	Torino		Italy
202	1182.17.5201 Centro Médico La Raza IMSS	Col. La Raza, Mexico		Mexico
203	1182.17.5203 Hospital Civil Nuevo de Guadalajara	Guadalajara		Mexico
204	1182.17.5206 Centro Medico San Vicente	Monterrey, N.l., Mexico		Mexico
205	1182.17.3101 Boehringer Ingelheim Investigational Site	Amsterdam		Netherlands
206	1182.17.3108 Boehringer Ingelheim Investigational Site	Groningen		Netherlands
207	1182.17.3105 Boehringer Ingelheim Investigational Site	Nijmegen		Netherlands
208	1182.17.202 Boehringer Ingelheim Investigational Site	Rotterdam		Netherlands
209	1182.17.3502 Hospital Condes Castro Guimarães	Cascais		Portugal
210	1182.17.705 Hospital Germans Trias i Pujol	Badalona		Spain
211	1182.17.701 Hospital Clínico y Provincial de Barcelona	Barcelona		Spain
212	1182.17.703 Hospital 12 de Octubre	Madrid		Spain
213	1182.17.704 Hospital Ramón y Cajal.	Madrid		Spain
214	1182.17.710 Hospital Gregorio Maranon	Madrid		Spain
215	1182.17.712 Hospital Clínico San Carlos	Madrid		Spain
216	1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria	Malaga		Spain
217	1182.17.713 Hospital Universitario Vírgen del Rocío	Sevilla		Spain
218	1182.17.714 Hospital General Universitario de Valencia	Valencia		Spain
219	1182.17.720 Hospital La Fe	Valencia		Spain
220	1182.17.718 Complejo Hospitalario Xeral - Cíes	Vigo		Spain
221	1182.17.4101 DIM / Abteilung für Infektiologie	Basel		Switzerland
222	1182.17.4104 Département de médicine interne Div. Des maladies infectieus	Genève		Switzerland
223	1182.17.4103 DIM / Abteilung für Infektiologie	St. Gallen		Switzerland
224	1182.17.4102 Departement für Innere Medizin	Zürich		Switzerland
225	1182.17.4405 Boehringer Ingelheim Investigational Site	Brighton		United Kingdom
226	1182.17.4411 Boehringer Ingelheim Investigational Site	Liverpool		United Kingdom
227	1182.17.4404 Boehringer Ingelheim Investigational Site	London		United Kingdom
228	1182.17.4406 Boehringer Ingelheim Investigational Site	London		United Kingdom
229	1182.17.4408 Boehringer Ingelheim Investigational Site	London		United Kingdom
230	1182.17.4409 Boehringer Ingelheim Investigational Site	London		United Kingdom
231	1182.17.4414 Boehringer Ingelheim Investigational Site	London		United Kingdom
232	1182.17.4418 Boehringer Ingelheim Investigational Site	London		United Kingdom
233	1182.17.4407	Portsmouth		United Kingdom

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT00146328
• Other Study ID Numbers: 1182.17
• First Posted: Sep 7, 2005
• Last Update Posted: Mar 6, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: HIV Infections; Tipranavir

Study Results

Participant Flow

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Period Title: Overall Study
STARTED	291	255	449
COMPLETED	150	101	158
NOT COMPLETED	141	154	291

Baseline Characteristics

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	291	255	449	995
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.7 (8)	45.6 (8.2)	43.5 (7.7)	44.1 (8)
Sex: Female, Male (Count of Participants)
Female	35 12%	20 7.8%	44 9.8%	99 9.9%
Male	256 88%	235 92.2%	405 90.2%	896 90.1%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	1 0.3%	2 0.8%	6 1.3%

2. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	5 1.7%	14 5.5%	20 4.5%

3. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	9 3.1%	7 2.7%	7 1.6%

4. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	4 1.4%	0 0%	0 0%

5. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	2 0.7%	0 0%	1 0.2%

6. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	5 1.7%	1 0.4%	3 0.7%

7. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	6 2.1%	1 0.4%	2 0.4%

8. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	8 2.7%	0 0%	0 0%

9. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	4 1.4%	0 0%	2 0.4%

10. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	24 8.2%	13 5.1%	22 4.9%

11. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	47 16.2%	27 10.6%	42 9.4%

12. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	1 0.3%	0 0%	2 0.4%

13. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	31 10.7%	24 9.4%	48 10.7%

14. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	14 4.8%	8 3.1%	17 3.8%

15. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	16 5.5%	8 3.1%	12 2.7%

16. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	10 3.4%	2 0.8%	7 1.6%

17. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	82 28.2%	34 13.3%	30 6.7%

18. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	5 1.7%	6 2.4%	10 2.2%

19. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	4 1.4%	1 0.4%	1 0.2%

20. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	75 25.8%	57 22.4%	38 8.5%

21. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	2 0.7%	0 0%	5 1.1%

22. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	0 0%	0 0%	0 0%

23. Primary Outcome

Title	Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	48 16.5%	15 5.9%	12 2.7%

24. Primary Outcome

Title	Number of Patients With Adverse Events Leading to Death
Description	NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame	End of Trial (>288 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Number [participants]	10 3.4%	13 5.1%	26 5.8%

25. Secondary Outcome

Title	Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)
Description	Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)
Time Frame	Baseline to 192-240 week time interval

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	291	255	449
Median (Inter-Quartile Range) [Log 10 copies/mL]	-1.19	-0.62	-0.5

26. Secondary Outcome

Title	Change From Baseline in CD4 Cell Count (LOCF)
Description	Change from baseline in CD4 cell count with last observation carried forward(LOCF).
Time Frame	Baseline to 192-240 week time interval

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience	Group 2 (Highly Treatment Experienced Patients)	Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.	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.
Measure Participants	240	253	449
Mean (Standard Deviation) [cells/mm3]	83 (178)	26 (149)	21 (132)

Adverse Events

Time Frame	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).
Arm/Group Title	Group 1 (Patients With Varying Degrees of Treatment Experience		Group 2 (Highly Treatment Experienced Patients)		Group 3 (Tipranavir naïve Patients)
Arm/Group Description	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: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.		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.
All Cause Mortality
	Group 1 (Patients With Varying Degrees of Treatment Experience		Group 2 (Highly Treatment Experienced Patients)		Group 3 (Tipranavir naïve Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1 (Patients With Varying Degrees of Treatment Experience		Group 2 (Highly Treatment Experienced Patients)		Group 3 (Tipranavir naïve Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	100/ (NaN)		91/ (NaN)		135/ (NaN)
Blood and lymphatic system disorders
Anaemia	5/291 (1.7%)		10/255 (3.9%)		9/449 (2%)
Eosinophilia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Febrile neutropenia	1/291 (0.3%)		2/255 (0.8%)		1/449 (0.2%)
Iron deficiency anaemia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Leukopenia	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lymphadenopathy	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Lymphoid tissue hyperplasia	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Neutropenia	2/291 (0.7%)		0/255 (0%)		1/449 (0.2%)
Pancytopenia	0/291 (0%)		1/255 (0.4%)		2/449 (0.4%)
Thrombocytopenia	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Cardiac disorders
Acute myocardial infarction	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Angina pectoris	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Angina unstable	2/291 (0.7%)		2/255 (0.8%)		0/449 (0%)
Arrhythmia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Atrial fibrillation	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Cardiac arrest	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cardiac failure	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Cardiac failure congestive	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Cardiac tamponade	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Cardio-respiratory arrest	1/291 (0.3%)		1/255 (0.4%)		2/449 (0.4%)
Cardiopulmonary failure	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cor pulmonale	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Coronary artery disease	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Intracardiac thrombus	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Ischaemic cardiomyopathy	0/291 (0%)		2/255 (0.8%)		0/449 (0%)
Myocardial infarction	2/291 (0.7%)		2/255 (0.8%)		0/449 (0%)
Right ventricular failure	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Tachycardia	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Ventricular tachycardia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Congenital, familial and genetic disorders
Fanconi syndrome	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Ear and labyrinth disorders
Ear pain	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Eye disorders
Cataract	0/291 (0%)		2/255 (0.8%)		0/449 (0%)
Retinal artery embolism	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Retinal detachment	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Vision blurred	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Gastrointestinal disorders
Abdominal hernia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Abdominal pain	5/291 (1.7%)		2/255 (0.8%)		8/449 (1.8%)
Abdominal pain upper	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Anal haemorrhage	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Anal ulcer	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Aphthous stomatitis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Appendicitis perforated	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Constipation	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Diarrhoea	10/291 (3.4%)		5/255 (2%)		7/449 (1.6%)
Diverticular perforation	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Diverticulum	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Enteritis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Faecal incontinence	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Faeces discoloured	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Gastritis	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Gastrointestinal disorder	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Gastrointestinal haemorrhage	2/291 (0.7%)		2/255 (0.8%)		0/449 (0%)
Haemorrhoidal haemorrhage	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Haemorrhoids	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Impaired gastric emptying	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Inguinal hernia	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Intestinal perforation	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Irritable bowel syndrome	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lip ulceration	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Mesenteric vein thrombosis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Nausea	2/291 (0.7%)		3/255 (1.2%)		3/449 (0.7%)
Oesophageal pain	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Oesophageal stenosis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Oesophageal ulcer	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Oesophagitis	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Oral disorder	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Oral pain	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Pancreatitis	1/291 (0.3%)		2/255 (0.8%)		3/449 (0.7%)
Pancreatitis acute	0/291 (0%)		2/255 (0.8%)		2/449 (0.4%)
Peptic ulcer	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Peritoneal adhesions	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Proctitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Rectal haemorrhage	2/291 (0.7%)		0/255 (0%)		1/449 (0.2%)
Vomiting	3/291 (1%)		4/255 (1.6%)		4/449 (0.9%)
General disorders
Adverse drug reaction	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Asthenia	1/291 (0.3%)		2/255 (0.8%)		6/449 (1.3%)
Chest pain	6/291 (2.1%)		3/255 (1.2%)		3/449 (0.7%)
Chills	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Cyst	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Death	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Drug withdrawal syndrome	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Fatigue	0/291 (0%)		1/255 (0.4%)		2/449 (0.4%)
General physical health deterioration	1/291 (0.3%)		2/255 (0.8%)		2/449 (0.4%)
Generalised oedema	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Influenza like illness	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Local swelling	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Malaise	2/291 (0.7%)		0/255 (0%)		2/449 (0.4%)
Multi-organ failure	0/291 (0%)		2/255 (0.8%)		3/449 (0.7%)
Oedema peripheral	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Pain	2/291 (0.7%)		0/255 (0%)		1/449 (0.2%)
Polyserositis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Pyrexia	14/291 (4.8%)		13/255 (5.1%)		19/449 (4.2%)
Hepatobiliary disorders
Acute hepatic failure	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cholangitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cholecystitis	1/291 (0.3%)		3/255 (1.2%)		1/449 (0.2%)
Cholelithiasis	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Cytolytic hepatitis	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Hepatic failure	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hepatosplenomegaly	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hepatotoxicity	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hyperbilirubinaemia	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Jaundice	0/291 (0%)		2/255 (0.8%)		0/449 (0%)
Jaundice cholestatic	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Liver injury	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Immune system disorders
Anaphylactic shock	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Drug hypersensitivity	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Immune reconstitution syndrome	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Immunodeficiency	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Infections and infestations
AIDS dementia complex	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
AIDS encephalopathy	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Abdominal wall abscess	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Abscess	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Abscess limb	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Abscess neck	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Acanthamoeba infection	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Acquired immunodeficiency syndrome	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Anal abscess	1/291 (0.3%)		2/255 (0.8%)		1/449 (0.2%)
Anogenital warts	2/291 (0.7%)		0/255 (0%)		1/449 (0.2%)
Anorectal cellulitis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Appendiceal abscess	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Appendicitis	0/291 (0%)		0/255 (0%)		4/449 (0.9%)
Arthritis bacterial	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Aspergillosis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Bacteraemia	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Bacterial sepsis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Bronchitis	2/291 (0.7%)		3/255 (1.2%)		0/449 (0%)
Campylobacter intestinal infection	0/291 (0%)		1/255 (0.4%)		2/449 (0.4%)
Catheter related infection	1/291 (0.3%)		0/255 (0%)		3/449 (0.7%)
Cellulitis	3/291 (1%)		1/255 (0.4%)		2/449 (0.4%)
Cellulitis of male external genital organ	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Central line infection	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Cerebral toxoplasmosis	1/291 (0.3%)		0/255 (0%)		2/449 (0.4%)
Choriomeningitis lymphocytic	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Chronic sinusitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Clostridial infection	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cryptosporidiosis infection	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cytomegalovirus chorioretinitis	1/291 (0.3%)		1/255 (0.4%)		2/449 (0.4%)
Cytomegalovirus colitis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Cytomegalovirus infection	2/291 (0.7%)		1/255 (0.4%)		0/449 (0%)
Cytomegalovirus oesophagitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cytomegalovirus viraemia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Diarrhoea infectious	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Encephalitis cytomegalovirus	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Encephalitis herpes	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Encephalitis viral	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
End stage AIDS	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Endocarditis bacterial	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Enterocolitis infectious	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Escherichia urinary tract infection	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Fungal oesophagitis	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Gastritis fungal	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Gastroenteritis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Giardiasis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Groin abscess	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
HIV infection	0/291 (0%)		3/255 (1.2%)		1/449 (0.2%)
Hepatitis viral	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Herpes oesophagitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Herpes simplex	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Herpes zoster	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Infection	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Klebsiella bacteraemia	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Klebsiella sepsis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Lobar pneumonia	2/291 (0.7%)		3/255 (1.2%)		1/449 (0.2%)
Lower respiratory tract infection	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Lung abscess	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Lymph node tuberculosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Mediastinitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Meningitis cryptococcal	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Meningitis pneumococcal	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Molluscum contagiosum	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Mycobacterial infection	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Mycobacterium avium complex infection	3/291 (1%)		0/255 (0%)		3/449 (0.7%)
Necrotising herpetic retinopathy	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Oesophageal candidiasis	3/291 (1%)		2/255 (0.8%)		4/449 (0.9%)
Oral candidiasis	1/291 (0.3%)		1/255 (0.4%)		3/449 (0.7%)
Orchitis	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Papilloma viral infection	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Perineal abscess	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Perirectal abscess	0/291 (0%)		2/255 (0.8%)		0/449 (0%)
Pneumococcal infection	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Pneumococcal sepsis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Pneumocystis jiroveci pneumonia	2/291 (0.7%)		1/255 (0.4%)		8/449 (1.8%)
Pneumonia	6/291 (2.1%)		9/255 (3.5%)		9/449 (2%)
Pneumonia bacterial	1/291 (0.3%)		2/255 (0.8%)		1/449 (0.2%)
Pneumonia cytomegaloviral	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Pneumonia necrotising	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pneumonia pneumococcal	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Pneumonia staphylococcal	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Postoperative wound infection	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Progressive multifocal leukoencephalopathy	0/291 (0%)		4/255 (1.6%)		1/449 (0.2%)
Pseudomembranous colitis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Pseudomonal sepsis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Pulmonary tuberculosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pyelonephritis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Rectal abscess	1/291 (0.3%)		2/255 (0.8%)		0/449 (0%)
Respiratory tract infection viral	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Scrotal abscess	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Sepsis	3/291 (1%)		1/255 (0.4%)		2/449 (0.4%)
Septic shock	1/291 (0.3%)		0/255 (0%)		2/449 (0.4%)
Sinusitis	4/291 (1.4%)		0/255 (0%)		1/449 (0.2%)
Sinusitis aspergillus	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Sinusitis bacterial	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Staphylococcal infection	3/291 (1%)		2/255 (0.8%)		1/449 (0.2%)
Staphylococcal sepsis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Streptococcal infection	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Streptococcal sepsis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Subcutaneous abscess	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Syphilis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Urinary tract infection	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Urinary tract infection enterococcal	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Viral infection	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Viral sinusitis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Viral upper respiratory tract infection	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Injury, poisoning and procedural complications
Burns third degree	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Cerebral haemorrhage traumatic	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Fall	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Femur fracture	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Head injury	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Hip fracture	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Injury	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Joint dislocation	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lower limb fracture	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Neck injury	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Overdose	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Patella fracture	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Post procedural haematoma	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Post procedural haemorrhage	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Road traffic accident	1/291 (0.3%)		2/255 (0.8%)		2/449 (0.4%)
Skeletal injury	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Spinal compression fracture	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Splenic rupture	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Stress fracture	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Tendon rupture	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Transfusion reaction	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Traumatic brain injury	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Upper limb fracture	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Wound	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Investigations
Alanine aminotransferase increased	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Aspartate aminotransferase increased	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Biopsy breast	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Blood bilirubin increased	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Blood creatine phosphokinase increased	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Blood creatinine increased	1/291 (0.3%)		1/255 (0.4%)		0/449 (0%)
Blood lactate dehydrogenase increased	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Blood urea increased	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Fungus serology test positive	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Gamma-glutamyltransferase increased	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Haematocrit decreased	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Haemoglobin decreased	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hepatic enzyme increased	0/291 (0%)		3/255 (1.2%)		0/449 (0%)
Liver function test abnormal	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Liver scan abnormal	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Transaminases increased	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Weight decreased	1/291 (0.3%)		0/255 (0%)		2/449 (0.4%)
Metabolism and nutrition disorders
Cachexia	1/291 (0.3%)		2/255 (0.8%)		5/449 (1.1%)
Dehydration	4/291 (1.4%)		4/255 (1.6%)		9/449 (2%)
Electrolyte imbalance	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Failure to thrive	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Fat redistribution	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Malnutrition	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Metabolic acidosis	0/291 (0%)		1/255 (0.4%)		2/449 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Arthropathy	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Back pain	1/291 (0.3%)		0/255 (0%)		2/449 (0.4%)
Bone erosion	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Flank pain	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Intervertebral disc protrusion	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Neck pain	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Osteoarthritis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Osteonecrosis	6/291 (2.1%)		0/255 (0%)		0/449 (0%)
Osteoporosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pain in extremity	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Rhabdomyolysis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Spinal column stenosis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Spinal osteoarthritis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Spondyloarthropathy	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Anal cancer	4/291 (1.4%)		1/255 (0.4%)		2/449 (0.4%)
Anal cancer recurrent	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Anal cancer stage 0	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
B-cell lymphoma	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Basal cell carcinoma	1/291 (0.3%)		1/255 (0.4%)		2/449 (0.4%)
Bowen's disease	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Bowenoid papulosis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Burkitt's lymphoma	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Colorectal carcinoma stage 0	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Diffuse large B-cell lymphoma	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Hodgkin's disease	3/291 (1%)		1/255 (0.4%)		1/449 (0.2%)
Hodgkin's disease stage IV	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Kaposi's sarcoma	0/291 (0%)		1/255 (0.4%)		3/449 (0.7%)
Laryngeal cancer	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Lung cancer metastatic	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Lymphoma	2/291 (0.7%)		1/255 (0.4%)		1/449 (0.2%)
Malignant anorectal neoplasm	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Malignant melanoma	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Neoplasm malignant	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Non-Hodgkin's lymphoma	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Penis carcinoma	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Plasmablastic lymphoma	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Rectal cancer	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Salivary gland neoplasm	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Splenic neoplasm malignancy unspecified	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Squamous cell carcinoma	3/291 (1%)		0/255 (0%)		0/449 (0%)
Squamous cell carcinoma of skin	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Uterine leiomyoma	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Nervous system disorders
Brain oedema	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Carotid artery stenosis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Carpal tunnel syndrome	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Cerebral haematoma	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cerebral haemorrhage	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Cerebrovascular accident	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Convulsion	1/291 (0.3%)		1/255 (0.4%)		3/449 (0.7%)
Encephalitis	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Epilepsy	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Facial palsy	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Haemorrhage intracranial	1/291 (0.3%)		0/255 (0%)		1/449 (0.2%)
Headache	1/291 (0.3%)		1/255 (0.4%)		5/449 (1.1%)
Hypertensive encephalopathy	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Intracranial aneurysm	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Intracranial hypotension	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Ischaemic stroke	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lethargy	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Leukoencephalopathy	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Loss of consciousness	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Memory impairment	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Nervous system disorder	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Neuropathy peripheral	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Paraesthesia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Sinus headache	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Syncope	3/291 (1%)		0/255 (0%)		0/449 (0%)
Transient ischaemic attack	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Tremor	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Psychiatric disorders
Anxiety disorder	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Completed suicide	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Confusional state	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Depression	3/291 (1%)		2/255 (0.8%)		1/449 (0.2%)
Drug abuse	2/291 (0.7%)		0/255 (0%)		0/449 (0%)
Hallucination	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hallucination, tactile	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Hypomania	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Mental status changes	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Paranoia	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Suicide attempt	2/291 (0.7%)		0/255 (0%)		1/449 (0.2%)
Withdrawal syndrome	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Renal and urinary disorders
Calculus ureteric	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Focal glomerulosclerosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Glomerulonephritis proliferative	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Nephritis interstitial	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Nephrolithiasis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Oliguria	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Renal colic	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Renal failure	3/291 (1%)		3/255 (1.2%)		4/449 (0.9%)
Renal failure acute	8/291 (2.7%)		2/255 (0.8%)		4/449 (0.9%)
Renal impairment	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Renal tubular acidosis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Renal tubular disorder	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Renal tubular necrosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Reproductive system and breast disorders
Breast pain	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Cervical dysplasia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Epididymitis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Fallopian tube obstruction	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Haematosalpinx	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Metrorrhagia	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Prostatitis	1/291 (0.3%)		1/255 (0.4%)		1/449 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Asthma	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Bronchospasm	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Chronic obstructive pulmonary disease	1/291 (0.3%)		2/255 (0.8%)		1/449 (0.2%)
Cough	0/291 (0%)		0/255 (0%)		2/449 (0.4%)
Dyspnoea	0/291 (0%)		4/255 (1.6%)		2/449 (0.4%)
Dyspnoea exertional	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Haemoptysis	0/291 (0%)		1/255 (0.4%)		2/449 (0.4%)
Interstitial lung disease	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Lower respiratory tract inflammation	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Lung disorder	0/291 (0%)		2/255 (0.8%)		3/449 (0.7%)
Pneumomediastinum	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pneumonia aspiration	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pneumothorax	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Productive cough	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Pulmonary embolism	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Pulmonary oedema	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Respiratory disorder	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Respiratory distress	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Respiratory failure	0/291 (0%)		2/255 (0.8%)		1/449 (0.2%)
Snoring	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Tachypnoea	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Skin and subcutaneous tissue disorders
Drug eruption	0/291 (0%)		1/255 (0.4%)		1/449 (0.2%)
Lipodystrophy acquired	1/291 (0.3%)		2/255 (0.8%)		0/449 (0%)
Lipohypertrophy	2/291 (0.7%)		1/255 (0.4%)		0/449 (0%)
Rash	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Rash pruritic	0/291 (0%)		2/255 (0.8%)		0/449 (0%)
Skin exfoliation	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Skin lesion	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Skin toxicity	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Surgical and medical procedures
Colostomy	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Intestinal anastomosis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Intestinal operation	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lymphadenectomy	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Umbilical hernia repair	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Wisdom teeth removal	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Vascular disorders
Air embolism	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Arteriosclerosis	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Deep vein thrombosis	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Hypertension	0/291 (0%)		1/255 (0.4%)		3/449 (0.7%)
Hypotension	1/291 (0.3%)		0/255 (0%)		2/449 (0.4%)
Hypovolaemic shock	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Lymphocele	0/291 (0%)		1/255 (0.4%)		0/449 (0%)
Necrosis ischaemic	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Varicose vein	0/291 (0%)		0/255 (0%)		1/449 (0.2%)
Venous occlusion	1/291 (0.3%)		0/255 (0%)		0/449 (0%)
Other (Not Including Serious) Adverse Events
	Group 1 (Patients With Varying Degrees of Treatment Experience		Group 2 (Highly Treatment Experienced Patients)		Group 3 (Tipranavir naïve Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	284/ (NaN)		250/ (NaN)		406/ (NaN)
Blood and lymphatic system disorders
Anaemia	22/291 (7.6%)		22/255 (8.6%)		19/449 (4.2%)
Lymphadenopathy	18/291 (6.2%)		11/255 (4.3%)		20/449 (4.5%)
Gastrointestinal disorders
Abdominal distension	15/291 (5.2%)		5/255 (2%)		9/449 (2%)
Abdominal pain	45/291 (15.5%)		26/255 (10.2%)		42/449 (9.4%)
Abdominal pain upper	17/291 (5.8%)		18/255 (7.1%)		16/449 (3.6%)
Constipation	21/291 (7.2%)		13/255 (5.1%)		13/449 (2.9%)
Diarrhoea	152/291 (52.2%)		107/255 (42%)		126/449 (28.1%)
Dyspepsia	21/291 (7.2%)		16/255 (6.3%)		9/449 (2%)
Flatulence	19/291 (6.5%)		18/255 (7.1%)		23/449 (5.1%)
Haemorrhoids	15/291 (5.2%)		6/255 (2.4%)		15/449 (3.3%)
Nausea	101/291 (34.7%)		62/255 (24.3%)		72/449 (16%)
Vomiting	56/291 (19.2%)		30/255 (11.8%)		35/449 (7.8%)
General disorders
Adverse drug reaction	9/291 (3.1%)		27/255 (10.6%)		34/449 (7.6%)
Asthenia	27/291 (9.3%)		28/255 (11%)		35/449 (7.8%)
Chest pain	18/291 (6.2%)		9/255 (3.5%)		11/449 (2.4%)
Fatigue	80/291 (27.5%)		58/255 (22.7%)		47/449 (10.5%)
Influenza like illness	17/291 (5.8%)		11/255 (4.3%)		10/449 (2.2%)
Injection site reaction	12/291 (4.1%)		22/255 (8.6%)		24/449 (5.3%)
Pain	18/291 (6.2%)		5/255 (2%)		9/449 (2%)
Pyrexia	53/291 (18.2%)		44/255 (17.3%)		59/449 (13.1%)
Infections and infestations
Anogenital warts	17/291 (5.8%)		12/255 (4.7%)		9/449 (2%)
Bronchitis	42/291 (14.4%)		39/255 (15.3%)		42/449 (9.4%)
Folliculitis	18/291 (6.2%)		8/255 (3.1%)		9/449 (2%)
Gastroenteritis	12/291 (4.1%)		18/255 (7.1%)		17/449 (3.8%)
Herpes simplex	15/291 (5.2%)		8/255 (3.1%)		14/449 (3.1%)
Herpes zoster	23/291 (7.9%)		10/255 (3.9%)		20/449 (4.5%)
Influenza	31/291 (10.7%)		18/255 (7.1%)		29/449 (6.5%)
Nasopharyngitis	54/291 (18.6%)		43/255 (16.9%)		60/449 (13.4%)
Oesophageal candidiasis	7/291 (2.4%)		17/255 (6.7%)		17/449 (3.8%)
Onychomycosis	19/291 (6.5%)		9/255 (3.5%)		13/449 (2.9%)
Oral candidiasis	27/291 (9.3%)		34/255 (13.3%)		43/449 (9.6%)
Oral herpes	17/291 (5.8%)		14/255 (5.5%)		18/449 (4%)
Rhinitis	20/291 (6.9%)		14/255 (5.5%)		10/449 (2.2%)
Sinusitis	48/291 (16.5%)		29/255 (11.4%)		33/449 (7.3%)
Upper respiratory tract infection	76/291 (26.1%)		27/255 (10.6%)		36/449 (8%)
Urinary tract infection	23/291 (7.9%)		8/255 (3.1%)		15/449 (3.3%)
Investigations
Weight decreased	27/291 (9.3%)		20/255 (7.8%)		26/449 (5.8%)
Metabolism and nutrition disorders
Anorexia	19/291 (6.5%)		16/255 (6.3%)		30/449 (6.7%)
Hyperlipidaemia	31/291 (10.7%)		9/255 (3.5%)		7/449 (1.6%)
Hypertriglyceridaemia	23/291 (7.9%)		15/255 (5.9%)		13/449 (2.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	47/291 (16.2%)		20/255 (7.8%)		29/449 (6.5%)
Back pain	43/291 (14.8%)		23/255 (9%)		30/449 (6.7%)
Muscle spasms	25/291 (8.6%)		16/255 (6.3%)		22/449 (4.9%)
Myalgia	32/291 (11%)		18/255 (7.1%)		19/449 (4.2%)
Pain in extremity	41/291 (14.1%)		15/255 (5.9%)		16/449 (3.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	21/291 (7.2%)		17/255 (6.7%)		18/449 (4%)
Nervous system disorders
Dizziness	30/291 (10.3%)		16/255 (6.3%)		26/449 (5.8%)
Headache	73/291 (25.1%)		34/255 (13.3%)		53/449 (11.8%)
Hypoaesthesia	19/291 (6.5%)		12/255 (4.7%)		4/449 (0.9%)
Neuropathy peripheral	34/291 (11.7%)		8/255 (3.1%)		24/449 (5.3%)
Paraesthesia	17/291 (5.8%)		11/255 (4.3%)		10/449 (2.2%)
Psychiatric disorders
Anxiety	27/291 (9.3%)		6/255 (2.4%)		22/449 (4.9%)
Depression	50/291 (17.2%)		32/255 (12.5%)		30/449 (6.7%)
Insomnia	46/291 (15.8%)		27/255 (10.6%)		31/449 (6.9%)
Reproductive system and breast disorders
Erectile dysfunction	24/291 (8.2%)		11/255 (4.3%)		10/449 (2.2%)
Respiratory, thoracic and mediastinal disorders
Cough	45/291 (15.5%)		46/255 (18%)		53/449 (11.8%)
Dyspnoea	21/291 (7.2%)		12/255 (4.7%)		10/449 (2.2%)
Nasal congestion	20/291 (6.9%)		7/255 (2.7%)		9/449 (2%)
Oropharyngeal pain	27/291 (9.3%)		15/255 (5.9%)		20/449 (4.5%)
Skin and subcutaneous tissue disorders
Lipodystrophy acquired	18/291 (6.2%)		7/255 (2.7%)		9/449 (2%)
Night sweats	15/291 (5.2%)		12/255 (4.7%)		17/449 (3.8%)
Pruritus	24/291 (8.2%)		17/255 (6.7%)		16/449 (3.6%)
Rash	44/291 (15.1%)		25/255 (9.8%)		29/449 (6.5%)
Vascular disorders
Hypertension	27/291 (9.3%)		5/255 (2%)		8/449 (1.8%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.