An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
- Conditions
- HIV Infections
- Registration Number
- NCT00933205
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- Age equal or more than 18 years
- Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
- Patient voluntarily provides written informed consent to participate, in compliance with local law.
-
Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
-
Required use of restricted medications.
-
Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding.
-
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.
-
Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
-
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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (215)
1182.16.3202 Boehringer Ingelheim Investigational Site
🇧🇪Antwerpen, Belgium
1182.16.3203 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, 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
1182.16.3209 Boehringer Ingelheim Investigational Site
🇧🇪Luxembourg, Belgium
1182.16.3004 "Attiko" Hospital, 4th Internal Medicine Clinic, UOA
🇬🇷Athens, Greece
1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS
🇧🇷Campinas - Sp, Brazil
1182.16.5504 Hospital das Clínicas de Porto Alegre
🇧🇷Porto Alegre - Rs, Brazil
1182.16.1109 Infectious Diseases and HIV
🇨🇦Toronto, Ontario, Canada
1182.16.5502 Hospital Nossa Senhora da Conceiç
🇧🇷Porto Alegre - Rs, Brazil
1182.16.1110 Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
1182.16.3211 Boehringer Ingelheim Investigational Site
🇧🇪Charleroi, Belgium
1182.16.1131 The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
1182.16.1112 McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
1182.16.1101 St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
1182.16.3910 Ospedale Luigi Sacco
🇮🇹Milano, Italy
1182.16.3942 Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
1182.16.1114 Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
1182.16.1106 Positive Care Clinic
🇨🇦Whitby, Ontario, Canada
1182.16.1128 Centre for Clinical Research
🇨🇦Halifax, Nova Scotia, Canada
1182.16.1107 Sunnybrook & Woman's College Health Science Centre
🇨🇦Toronto, Ontario, Canada
1182.16.3951 Ospedale Civile Umberto I
🇮🇹Mestre-VE, 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
1182.16.3449 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.16.3438 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.16.3442 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.16.3488 Boehringer Ingelheim Investigational Site
🇪🇸Gandia (Valencia), Spain
1182.16.3492
🇪🇸Mataró (Barcelona), Spain
1182.16.3477 Boehringer Ingelheim Investigational Site
🇪🇸Hospitalet de Llobregat (Barcelona), Spain
1182.16.3498 Boehringer Ingelheim Investigational Site
🇪🇸Ibiza, Spain
1182.16.3409 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3458 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1182.16.4504 Boehringer Ingelheim Investigational Site
🇩🇰Odense C, Denmark
1182.16.4502 Boehringer Ingelheim Investigational Site
🇩🇰Hvidovre, Denmark
1182.16.3925 Azienda Ospedaliera Carlo Poma
🇮🇹Mantova, Italy
1182.16.3903 Ospedale L. Sacco
🇮🇹Milano, Italy
1182.16.3904 Ospedale Luigi Sacco
🇮🇹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
1182.16.3914 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
1182.16.3931 Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
1182.16.3930 Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
1182.16.3907 IRCCS Lazzaro Spallanzani
🇮🇹Roma, Italy
1182.16.3915 Azienda Policlinico Umberto I
🇮🇹Roma, Italy
1182.16.3960 Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
1182.16.3970 Ospedale San Giuseppe Moscati
🇮🇹Statte (ta), Italy
1182.16.3917 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
1182.16.3916 Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
1182.16.5509
🇧🇷Rio de Janeiro - Rj, Brazil
1182.16.5510
🇧🇷Santos - 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
1182.16.1104 University of Alberta H-Site
🇨🇦Edmonton, Alberta, Canada
1182.16.1115
🇨🇦Toronto, Ontario, Canada
1182.16.1120 Metropolitan Campus
🇨🇦Windsor, Ontario, Canada
1182.16.1116 Immune Deficiency Treatment Centre
🇨🇦Monteal, Quebec, Canada
1182.16.3476 Boehringer Ingelheim Investigational Site
🇪🇸Cadiz, Spain
1182.16.3463 Boehringer Ingelheim Investigational Site
🇪🇸Bilbao, 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
1182.16.3443 Boehringer Ingelheim Investigational Site
🇪🇸Gerona, Spain
1182.16.3418 Boehringer Ingelheim Investigational Site
🇪🇸Gijón (ASTURIAS), Spain
1182.16.3411 Boehringer Ingelheim Investigational Site
🇪🇸Getafe (Madrid), Spain
1182.16.3427 Boehringer Ingelheim Investigational Site
🇪🇸Granada, Spain
1182.16.3439 Boehringer Ingelheim Investigational Site
🇪🇸Granollers (Barcelona), Spain
1182.16.3445 Boehringer Ingelheim Investigational Site
🇪🇸Hospitalet de Llobregat, Spain
1182.16.3479 Boehringer Ingelheim Investigational Site
🇪🇸Jaen, 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
1182.16.3480 Boehringer Ingelheim Investigational Site
🇪🇸Huelva, Spain
1182.16.3423 Boehringer Ingelheim Investigational Site
🇪🇸Jerez de la Frontera, Spain
1182.16.3434 Boehringer Ingelheim Investigational Site
🇪🇸Las Palmas de Gran Canaria, Spain
1182.16.3401 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, 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
1182.16.3424 Boehringer Ingelheim Investigational Site
🇪🇸Malaga, Spain
1182.16.3404 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3405 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3407 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3408 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3413 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3402 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3426 Boehringer Ingelheim Investigational Site
🇪🇸Marbella (Málaga), Spain
1182.16.3493 Boehringer Ingelheim Investigational Site
🇪🇸Mataro, Spain
1182.16.3489 Boehringer Ingelheim Investigational Site
🇪🇸Navarra, Spain
1182.16.3425 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1182.16.3410 Boehringer Ingelheim Investigational Site
🇪🇸Móstoles (Madrid), Spain
1182.16.3472 Boehringer Ingelheim Investigational Site
🇪🇸Ourense, Spain
1182.16.3417 Boehringer Ingelheim Investigational Site
🇪🇸Oviedo (Asturias), Spain
1182.16.3461 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, 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
1182.16.3453 Boehringer Ingelheim Investigational Site
🇪🇸San Sebastian, Spain
1182.16.3446 Boehringer Ingelheim Investigational Site
🇪🇸Sabadell (Barcelona), Spain
1182.16.3435 Boehringer Ingelheim Investigational Site
🇪🇸Santa Cruz de Tenerife, Spain
1182.16.3420 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1182.16.3421 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1182.16.3403 Boehringer Ingelheim Investigational Site
🇪🇸Valladolid, 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
1182.16.3416 Boehringer Ingelheim Investigational Site
🇪🇸Vigo, Spain
1182.16.3467 Boehringer Ingelheim Investigational Site
🇪🇸Vigo (Pontevedra), Spain
1182.16.3482 Boehringer Ingelheim Investigational Site
🇪🇸Villajoyosa (ALICANTE), Spain
1182.16.3483 Boehringer Ingelheim Investigational Site
🇪🇸Vitoria, Spain
1182.16.3911 U.O. di Malattie Infettive
🇮🇹Foggia, Italy
1182.16.3212 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza
🇧🇷Fortaleza - Ce, Brazil
1182.16.5512 Ambulatório de DST/ AIDS - RS
🇧🇷Porto Alegre - Rs, Brazil
1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras
🇧🇷Rio de Janeiro, Brazil
1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
🇧🇷São Paulo - Sp, Brazil
1182.16.5508
🇧🇷Vila Mariana, Brazil
1182.16.1118
🇨🇦Calgary, Alberta, Canada
1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.
🇨🇦Toronto, Ontario, Canada
1182.16.1132 Infectious Diseases Consultant
🇨🇦Oakville, Ontario, Canada
1182.16.1125 St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
1182.16.1111 Downtown Infectious Diseases Clinic
🇨🇦Vancouver, British Columbia, Canada
1182.16.1124
🇨🇦Toronto, Ontario, Canada
1182.16.3905 IRCCS Lazzaro Spallanzani
🇮🇹Roma, Italy
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
1182.16.3464 Boehringer Ingelheim Investigational Site
🇸🇻Vizcaya, El Salvador
1182.16.3491 Boehringer Ingelheim Investigational Site
🇸🇻Vic (Barcelona), El Salvador
1182.16.3002 "Greek Red Cross" Hospital, 3rd Internal Medicine Clinic
🇬🇷Athens, Greece
1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas
🇬🇷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
1182.16.3009 AHEPA Hospital
🇬🇷Thessaloniki, Greece
1182.16.3010 University Hospital of Patras
🇬🇷Patras, Greece
1182.16.3008 "Tzanio" Hospital
🇬🇷Piraeus, Greece
1182.16.3932 Azienda Ospedaliera Umberto I
🇮🇹Ancona, Italy
1182.16.3958 A.O. Ospedale Clinico Consorziale
🇮🇹Bari, Italy
1182.16.3923 Ospedale Santa Maria Annunziata
🇮🇹Antella (fi), Italy
1182.16.3952 Centro di riferimento oncologico
🇮🇹Aviano - PD, Italy
1182.16.3946 Ospedale Policlinico S. Orsola Bologna
🇮🇹Bologna, Italy
1182.16.3920 Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
1182.16.3938 Ospedale Civile Regionale
🇮🇹Bolzano, Italy
1182.16.3928 Azienda Ospedaliera
🇮🇹Busto Arsizio (va), Italy
1182.16.3901 Università di Brescia
🇮🇹Brescia, Italy
1182.16.3957 A.O. Spedali Civili di Brescia
🇮🇹Brescia, 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
1182.16.3926 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
1182.16.3943 Policlinico Universitario di Udine
🇮🇹Udine, Italy
1182.16.3906 IRCCS Lazzaro Spallanzani
🇮🇹Roma, Italy
1182.16.3944 Ospedale Cisanello
🇮🇹Pisa, Italy
1182.16.3908 IRCCS Lazzaro Spallanzani
🇮🇹Roma, Italy
1182.16.3941 Istituto Nazionale per le Malattie Infettive
🇮🇹Roma, Italy
1182.16.3922 Università "La Sapienza"
🇮🇹Roma, Italy
1182.16.3504 Hospital Joaquim Urbano
🇵🇹Porto, Portugal
1182.16.3945 Istituto Malattie Infettive Università Di Sassari
🇮🇹Sassari, Italy
1182.16.3940 Presidio Ospedaliero Cà Foncello
🇮🇹Treviso, Italy
1182.16.3918 Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
1182.16.3949 Policlinico Rossi "Borgo Roma"
🇮🇹Verona, Italy
1182.16.3950 Ospedale SS. Giovanni e Paolo
🇮🇹Venezia, Italy
1182.16.3503 Centro Hospitalar de Lisboa
🇵🇹Lisboa, Portugal
1182.16.3502 Hospital São Francisco Xavier
🇵🇹Lisbon, Portugal
1182.16.3501 Unidade Local de Saúde de Matosinhos
🇵🇹Matosinhos, Portugal
1182.16.3959 Ospedale Civile di Vicenza - USSL 6
🇮🇹Vicenza, Italy
1182.16.3487 Boehringer Ingelheim Investigational Site
🇪🇸Arrecife (Lanzarote), Spain
1182.16.3484 Boehringer Ingelheim Investigational Site
🇪🇸Almeria, Spain
1182.16.3419 Boehringer Ingelheim Investigational Site
🇪🇸A Coruña, Spain
1182.16.3432 Boehringer Ingelheim Investigational Site
🇪🇸Alicante, Spain
1182.16.3412 Boehringer Ingelheim Investigational Site
🇪🇸Alcalá de Henares (Madrid), Spain
1182.16.3440
🇪🇸Badalona, Spain
1182.16.3474 Boehringer Ingelheim Investigational Site
🇪🇸Aviles (Asturias), Spain
1182.16.3454 Boehringer Ingelheim Investigational Site
🇪🇸Baracaldo (Vizcaya), Spain
1182.16.3428 Boehringer Ingelheim Investigational Site
🇪🇸Granada, Spain
1182.16.3494 Boehringer Ingelheim Investigational Site
🇪🇸Manresa (Barcelona), Spain
1182.16.3406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.16.3455 Boehringer Ingelheim Investigational Site
🇪🇸Santander, Spain
1182.16.3415 Boehringer Ingelheim Investigational Site
🇪🇸Santiago de Compostela, Spain
1182.16.3457 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1182.16.3460 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1182.16.3452 Boehringer Ingelheim Investigational Site
🇪🇸zARAGOZA, Spain
1182.16.3471 Boehringer Ingelheim Investigational Site
🇪🇸Zamora, Spain
1182.16.3451 Boehringer Ingelheim Investigational Site
🇪🇸Zaragoza, Spain
1182.16.3505 Hospital Santa Maria
🇵🇹Lisbon, Portugal
1182.16.3206 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1182.16.3205 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1182.16.3207 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1182.16.1126 HIV Care Programme
🇨🇦London, Ontario, Canada
1182.16.3448 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain