Official Title
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Brief Summary

The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

Approved for marketing
HIV Infections

Drug: Tipranavir

Eligibility Criteria

Inclusion Criteria:

1. Triple anti-retroviral class experienced patients with at least 2 previous PI-based
regimens who had failed or are intolerant to currently approved HIV-1 treatments.

2. Age equal or more than 18 years

3. Patient is willing to use an effective barrier method of contraception for the
duration of study participation and up to three months thereafter

4. Patient voluntarily provides written informed consent to participate, in compliance
with local law.

Exclusion Criteria:

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or
ritonavir

2. Required use of restricted medications.

3. Female patients of childbearing potential who have a positive pregnancy test at
baseline or are breast feeding.

4. Any medical condition which in the opinion of the investigator would interfere with
the patients' ability to participate in or adhere to the requirements of this
protocol.

5. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir
initiation and for the duration of study participation

6. Hepatic impairment evidenced by the following baseline laboratory findings:

- AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN

- AST or ALT more 2.5X ULN and total bilirubin more 2X ULN

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
Brazil
Canada
Denmark
El Salvador
Greece
Italy
Portugal
Spain
Locations

1182.16.3202 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium

1182.16.3203 Boehringer Ingelheim Investigational Site
Brussel, Belgium

1182.16.3205 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium

1182.16.3206 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium

1182.16.3207 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium

1182.16.3211 Boehringer Ingelheim Investigational Site
Charleroi, Belgium

1182.16.3204 Boehringer Ingelheim Investigational Site
Gent, Belgium

1182.16.3201 Boehringer Ingelheim Investigational Site
Leuven, Belgium

1182.16.3208 Boehringer Ingelheim Investigational Site
Liège, Belgium

1182.16.3212 Boehringer Ingelheim Investigational Site
Liège, Belgium

1182.16.3209 Boehringer Ingelheim Investigational Site
Luxembourg, Belgium

1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS
Campinas - Sp, Brazil

1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza
Fortaleza - Ce, Brazil

1182.16.5502 Hospital Nossa Senhora da Conceiç
Porto Alegre - Rs, Brazil

1182.16.5504 Hospital das Clínicas de Porto Alegre
Porto Alegre - Rs, Brazil

1182.16.5512 Ambulatório de DST/ AIDS - RS
Porto Alegre - Rs, Brazil

1182.16.5509
Rio de Janeiro - Rj, Brazil

1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras
Rio de Janeiro, Brazil

1182.16.5510
Santos - Sp, Brazil

1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
São Paulo - Sp, Brazil

1182.16.5506 Casa da AIDS da FMUSP
São Paulo - Sp, Brazil

1182.16.5507 Hospital do Servidor Público Estadual de São Paulo
São Paulo - Sp, Brazil

1182.16.5508
Vila Mariana, Brazil

1182.16.1118
Calgary, Alberta, Canada

1182.16.1104 University of Alberta H-Site
Edmonton, Alberta, Canada

1182.16.1101 St. Paul's Hospital
Vancouver, British Columbia, Canada

1182.16.1111 Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada

1182.16.1125 St. Boniface General Hospital
Winnipeg, Manitoba, Canada

1182.16.1131 The Moncton Hospital
Moncton, New Brunswick, Canada

1182.16.1128 Centre for Clinical Research
Halifax, Nova Scotia, Canada

1182.16.1112 McMaster University Medical Centre
Hamilton, Ontario, Canada

1182.16.1126 HIV Care Programme
London, Ontario, Canada

1182.16.1132 Infectious Diseases Consultant
Oakville, Ontario, Canada

1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario, Canada

1182.16.1107 Sunnybrook & Woman's College Health Science Centre
Toronto, Ontario, Canada

1182.16.1109 Infectious Diseases and HIV
Toronto, Ontario, Canada

1182.16.1110 Toronto East General Hospital
Toronto, Ontario, Canada

1182.16.1114 Toronto General Hospital
Toronto, Ontario, Canada

1182.16.1115
Toronto, Ontario, Canada

1182.16.1124
Toronto, Ontario, Canada

1182.16.1106 Positive Care Clinic
Whitby, Ontario, Canada

1182.16.1120 Metropolitan Campus
Windsor, Ontario, Canada

1182.16.1116 Immune Deficiency Treatment Centre
Monteal, Quebec, Canada

1182.16.1103 Hopital Notre Dame CHUM
Montreal, Quebec, Canada

1182.16.1113 Montreal Chest Institute, McGill University Health Centre
Montreal, Quebec, Canada

1182.16.1117 Clinique medicale l'Actuel
Montreal, Quebec, Canada

1182.16.1119
Montreal, Quebec, Canada

1182.16.1122 Infectious Diseases
Montreal, Quebec, Canada

1182.16.1130 Clinique Medicale LORI
Montreal, Quebec, Canada

1182.16.4501 Boehringer Ingelheim Investigational Site
Copenhagen, Denmark

1182.16.4502 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark

1182.16.4504 Boehringer Ingelheim Investigational Site
Odense C, Denmark

1182.16.3491 Boehringer Ingelheim Investigational Site
Vic (Barcelona), El Salvador

1182.16.3464 Boehringer Ingelheim Investigational Site
Vizcaya, El Salvador

1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas
Athens, Greece

1182.16.3002 "Greek Red Cross" Hospital, 3rd Internal Medicine Clinic
Athens, Greece

1182.16.3004 "Attiko" Hospital, 4th Internal Medicine Clinic, UOA
Athens, Greece

1182.16.3005 Laiko Hospital, 2nd District Blood Donation Center & Haemato
Athens, Greece

1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis
Athens, Greece

1182.16.3010 University Hospital of Patras
Patras, Greece

1182.16.3008 "Tzanio" Hospital
Piraeus, Greece

1182.16.3009 AHEPA Hospital
Thessaloniki, Greece

1182.16.3932 Azienda Ospedaliera Umberto I
Ancona, Italy

1182.16.3923 Ospedale Santa Maria Annunziata
Antella (fi), Italy

1182.16.3952 Centro di riferimento oncologico
Aviano - PD, Italy

1182.16.3958 A.O. Ospedale Clinico Consorziale
Bari, Italy

1182.16.3920 Ospedali Riuniti di Bergamo
Bergamo, Italy

1182.16.3946 Ospedale Policlinico S. Orsola Bologna
Bologna, Italy

1182.16.3938 Ospedale Civile Regionale
Bolzano, Italy

1182.16.3901 Università di Brescia
Brescia, Italy

1182.16.3957 A.O. Spedali Civili di Brescia
Brescia, Italy

1182.16.3928 Azienda Ospedaliera
Busto Arsizio (va), Italy

1182.16.3964 Ospedale SS. Trinità
Cagliari, Italy

1182.16.3947 U.O. Malattie Infettive
Catania, Italy

1182.16.3961 Ospedale Pugliese
Catanzaro, Italy

1182.16.3954 Ospedale Civile
Cuggiono-MI, Italy

1182.16.3963 Azienda Ospedaliera Arcispedale S. Anna
Ferrara, Italy

1182.16.3924 Azienda Ospedaliera Careggi
Firenze, Italy

1182.16.3902 Ospedali Riuniti di Foggia
Foggia, Italy

1182.16.3911 U.O. di Malattie Infettive
Foggia, Italy

1182.16.3926 Azienda Ospedaliera
Genova, Italy

1182.16.3927 Azienda Ospedaliera
Genova, Italy

1182.16.3929 Malattie Infettive
Genova, Italy

1182.16.3912 Ospedale "A. Manzoni"
Lecco, Italy

1182.16.3925 Azienda Ospedaliera Carlo Poma
Mantova, Italy

1182.16.3951 Ospedale Civile Umberto I
Mestre-VE, Italy

1182.16.3903 Ospedale L. Sacco
Milano, Italy

1182.16.3904 Ospedale Luigi Sacco
Milano, Italy

1182.16.3910 Ospedale Luigi Sacco
Milano, Italy

1182.16.3913 Fondazione Centro S. Raffaele del Monte Tabor
Milano, Italy

1182.16.3953 ospedale Niguarda
Milano, Italy

1182.16.3965 Ospedale Maggiore
Milano, Italy

1182.16.3968 Azienda Ospedaliera Policlinico
Modena, Italy

1182.16.3934 Azienda Ospedaliera D. Cotugno
Napoli, Italy

1182.16.3937 Azienda Ospedaliera D. Cotugno
Napoli, Italy

1182.16.3942 Azienda Ospedaliera di Padova
Padova, Italy

1182.16.3914 Presidio Ospedaliero di Verbania
PALLANZA (Verbania), Italy

1182.16.3948 U.O. Malattie Infettive ed Epatologia
Parma, Italy

1182.16.3909 I.R.C.C.S. Policlinico San Matteo
Pavia, Italy

1182.16.3921 IRCCS Policlinico San Matteo
Pavia, Italy

1182.16.3966 Policlinico Monteluce
Perugia, Italy

1182.16.3955 Ospedale San Salvatore
Pesaro, Italy

1182.16.3967 Ospedale Civile dello Spirito Santo
Pescara, Italy

1182.16.3944 Ospedale Cisanello
Pisa, Italy

1182.16.3931 Ospedale Santa Maria delle Croci
Ravenna, Italy

1182.16.3930 Arcispedale S. Maria Nuova
Reggio Emilia, Italy

1182.16.3905 IRCCS Lazzaro Spallanzani
Roma, Italy

1182.16.3906 IRCCS Lazzaro Spallanzani
Roma, Italy

1182.16.3907 IRCCS Lazzaro Spallanzani
Roma, Italy

1182.16.3908 IRCCS Lazzaro Spallanzani
Roma, Italy

1182.16.3915 Azienda Policlinico Umberto I
Roma, Italy

1182.16.3922 Università "La Sapienza"
Roma, Italy

1182.16.3941 Istituto Nazionale per le Malattie Infettive
Roma, Italy

1182.16.3960 Università Cattolica del Sacro Cuore
Roma, Italy

1182.16.3945 Istituto Malattie Infettive Università Di Sassari
Sassari, Italy

1182.16.3970 Ospedale San Giuseppe Moscati
Statte (ta), Italy

1182.16.3917 Ospedale Amedeo di Savoia
Torino, Italy

1182.16.3918 Ospedale Amedeo di Savoia
Torino, Italy

1182.16.3919 Ospedale Amedeo di Savoia
Torino, Italy

1182.16.3933 Azienda Ospedaliera Umberto I
Torrette Di Ancona, Italy

1182.16.3939 Ospedale Regionale
Torrette Di Ancona, Italy

1182.16.3940 Presidio Ospedaliero Cà Foncello
Treviso, Italy

1182.16.3943 Policlinico Universitario di Udine
Udine, Italy

1182.16.3916 Ospedale di Circolo e Fondazione Macchi
Varese, Italy

1182.16.3950 Ospedale SS. Giovanni e Paolo
Venezia, Italy

1182.16.3949 Policlinico Rossi "Borgo Roma"
Verona, Italy

1182.16.3959 Ospedale Civile di Vicenza - USSL 6
Vicenza, Italy

1182.16.3503 Centro Hospitalar de Lisboa
Lisboa, Portugal

1182.16.3502 Hospital São Francisco Xavier
Lisbon, Portugal

1182.16.3505 Hospital Santa Maria
Lisbon, Portugal

1182.16.3501 Unidade Local de Saúde de Matosinhos
Matosinhos, Portugal

1182.16.3504 Hospital Joaquim Urbano
Porto, Portugal

1182.16.3419 Boehringer Ingelheim Investigational Site
A Coruña, Spain

1182.16.3412 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid), Spain

1182.16.3432 Boehringer Ingelheim Investigational Site
Alicante, Spain

1182.16.3484 Boehringer Ingelheim Investigational Site
Almeria, Spain

1182.16.3487 Boehringer Ingelheim Investigational Site
Arrecife (Lanzarote), Spain

1182.16.3474 Boehringer Ingelheim Investigational Site
Aviles (Asturias), Spain

1182.16.3440
Badalona, Spain

1182.16.3454 Boehringer Ingelheim Investigational Site
Baracaldo (Vizcaya), Spain

1182.16.3438 Boehringer Ingelheim Investigational Site
Barcelona, Spain

1182.16.3442 Boehringer Ingelheim Investigational Site
Barcelona, Spain

1182.16.3448 Boehringer Ingelheim Investigational Site
Barcelona, Spain

1182.16.3449 Boehringer Ingelheim Investigational Site
Barcelona, Spain

1182.16.3463 Boehringer Ingelheim Investigational Site
Bilbao, Spain

1182.16.3476 Boehringer Ingelheim Investigational Site
Cadiz, Spain

1182.16.3430 Boehringer Ingelheim Investigational Site
Cartagena, Spain

1182.16.3462 Boehringer Ingelheim Investigational Site
Castellón, Spain

1182.16.3429 Boehringer Ingelheim Investigational Site
Cordoba, Spain

1182.16.3431 Boehringer Ingelheim Investigational Site
El Palmar (MURCIA), Spain

1182.16.3488 Boehringer Ingelheim Investigational Site
Gandia (Valencia), Spain

1182.16.3443 Boehringer Ingelheim Investigational Site
Gerona, Spain

1182.16.3411 Boehringer Ingelheim Investigational Site
Getafe (Madrid), Spain

1182.16.3418 Boehringer Ingelheim Investigational Site
Gijón (ASTURIAS), Spain

1182.16.3427 Boehringer Ingelheim Investigational Site
Granada, Spain

1182.16.3428 Boehringer Ingelheim Investigational Site
Granada, Spain

1182.16.3439 Boehringer Ingelheim Investigational Site
Granollers (Barcelona), Spain

1182.16.3477 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat (Barcelona), Spain

1182.16.3445 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain

1182.16.3480 Boehringer Ingelheim Investigational Site
Huelva, Spain

1182.16.3498 Boehringer Ingelheim Investigational Site
Ibiza, Spain

1182.16.3479 Boehringer Ingelheim Investigational Site
Jaen, Spain

1182.16.3423 Boehringer Ingelheim Investigational Site
Jerez de la Frontera, Spain

1182.16.3436 Boehringer Ingelheim Investigational Site
La Laguna (santa Cruz de Tenerife), Spain

1182.16.3437 Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canarias, Spain

1182.16.3434 Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canaria, Spain

1182.16.3470 Boehringer Ingelheim Investigational Site
Leganés (Madrid), Spain

1182.16.3441 Boehringer Ingelheim Investigational Site
Lleida, Spain

1182.16.3490 Boehringer Ingelheim Investigational Site
Logroño, Spain

1182.16.3401 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3402 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3404 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3406 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3407 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3408 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3409 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3413 Boehringer Ingelheim Investigational Site
Madrid, Spain

1182.16.3424 Boehringer Ingelheim Investigational Site
Malaga, Spain

1182.16.3494 Boehringer Ingelheim Investigational Site
Manresa (Barcelona), Spain

1182.16.3426 Boehringer Ingelheim Investigational Site
Marbella (Málaga), Spain

1182.16.3493 Boehringer Ingelheim Investigational Site
Mataro, Spain

1182.16.3492
Mataró (Barcelona), Spain

1182.16.3425 Boehringer Ingelheim Investigational Site
Málaga, Spain

1182.16.3410 Boehringer Ingelheim Investigational Site
Móstoles (Madrid), Spain

1182.16.3489 Boehringer Ingelheim Investigational Site
Navarra, Spain

1182.16.3472 Boehringer Ingelheim Investigational Site
Ourense, Spain

1182.16.3417 Boehringer Ingelheim Investigational Site
Oviedo (Asturias), Spain

1182.16.3496 Boehringer Ingelheim Investigational Site
Palma de Mallorca, Spain

1182.16.3450 Boehringer Ingelheim Investigational Site
Plama de Mallorca, Spain

1182.16.3497 Boehringer Ingelheim Investigational Site
Reus (Tarragona), Spain

1182.16.3446 Boehringer Ingelheim Investigational Site
Sabadell (Barcelona), Spain

1182.16.3453 Boehringer Ingelheim Investigational Site
San Sebastian, Spain

1182.16.3435 Boehringer Ingelheim Investigational Site
Santa Cruz de Tenerife, Spain

1182.16.3455 Boehringer Ingelheim Investigational Site
Santander, Spain

1182.16.3415 Boehringer Ingelheim Investigational Site
Santiago de Compostela, Spain

1182.16.3420 Boehringer Ingelheim Investigational Site
Sevilla, Spain

1182.16.3421 Boehringer Ingelheim Investigational Site
Sevilla, Spain

1182.16.3422 Boehringer Ingelheim Investigational Site
Sevilla, Spain

1182.16.3447 Boehringer Ingelheim Investigational Site
Tarragona, Spain

1182.16.3495 Boehringer Ingelheim Investigational Site
Tarragona, Spain

1182.16.3444 Boehringer Ingelheim Investigational Site
Terrassa, Spain

1182.16.3456 Boehringer Ingelheim Investigational Site
Valencia, Spain

1182.16.3457 Boehringer Ingelheim Investigational Site
Valencia, Spain

1182.16.3458 Boehringer Ingelheim Investigational Site
Valencia, Spain

1182.16.3460 Boehringer Ingelheim Investigational Site
Valencia, Spain

1182.16.3461 Boehringer Ingelheim Investigational Site
Valencia, Spain

1182.16.3403 Boehringer Ingelheim Investigational Site
Valladolid, Spain

1182.16.3467 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra), Spain

1182.16.3416 Boehringer Ingelheim Investigational Site
Vigo, Spain

1182.16.3482 Boehringer Ingelheim Investigational Site
Villajoyosa (ALICANTE), Spain

1182.16.3483 Boehringer Ingelheim Investigational Site
Vitoria, Spain

1182.16.3471 Boehringer Ingelheim Investigational Site
Zamora, Spain

1182.16.3451 Boehringer Ingelheim Investigational Site
Zaragoza, Spain

1182.16.3452 Boehringer Ingelheim Investigational Site
zARAGOZA, Spain

Boehringer Ingelheim, Study Chair
Boehringer Ingelheim

Boehringer Ingelheim
NCT Number
MeSH Terms
Infections
Communicable Diseases
Tipranavir