An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

NCT00933205 | Unknown

• 1 other identifier: 1182.16
• Study Type: expanded_access
• Target: N/A
• Locations: 9 countries
• Sites: 215

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.

Conditions

HIV Infections

Interventions

Tipranavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (215)

1182.16.3202 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

1182.16.3203 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.16.3205 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.16.3206 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.16.3207 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.16.3211 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1182.16.3204 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1182.16.3201 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1182.16.3208 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1182.16.3212 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1182.16.3209 Boehringer Ingelheim Investigational Site

Luxembourg, Belgium

Location

1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS

Campinas - Sp, Brazil

Location

1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza

Fortaleza - Ce, Brazil

Location

1182.16.5502 Hospital Nossa Senhora da Conceiç

Porto Alegre - Rs, Brazil

Location

1182.16.5504 Hospital das Clínicas de Porto Alegre

Porto Alegre - Rs, Brazil

Location

1182.16.5512 Ambulatório de DST/ AIDS - RS

Porto Alegre - Rs, Brazil

Location

1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras

Rio de Janeiro, Brazil

Location

1182.16.5509

Rio de Janeiro - Rj, Brazil

Location

1182.16.5510

Santos - Sp, Brazil

Location

1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo

São Paulo - Sp, Brazil

Location

1182.16.5506 Casa da AIDS da FMUSP

São Paulo - Sp, Brazil

Location

1182.16.5507 Hospital do Servidor Público Estadual de São Paulo

São Paulo - Sp, Brazil

Location

1182.16.5508

Vila Mariana, Brazil

Location

1182.16.1118

Calgary, Alberta, Canada

Location

1182.16.1104 University of Alberta H-Site

Edmonton, Alberta, Canada

Location

1182.16.1101 St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

1182.16.1111 Downtown Infectious Diseases Clinic

Vancouver, British Columbia, Canada

Location

1182.16.1125 St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

1182.16.1131 The Moncton Hospital

Moncton, New Brunswick, Canada

Location

1182.16.1128 Centre for Clinical Research

Halifax, Nova Scotia, Canada

Location

1182.16.1112 McMaster University Medical Centre

Hamilton, Ontario, Canada

Location

1182.16.1126 HIV Care Programme

London, Ontario, Canada

Location

1182.16.1132 Infectious Diseases Consultant

Oakville, Ontario, Canada

Location

1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.

Toronto, Ontario, Canada

Location

1182.16.1107 Sunnybrook & Woman's College Health Science Centre

Toronto, Ontario, Canada

Location

1182.16.1109 Infectious Diseases and HIV

Toronto, Ontario, Canada

Location

1182.16.1110 Toronto East General Hospital

Toronto, Ontario, Canada

Location

1182.16.1114 Toronto General Hospital

Toronto, Ontario, Canada

Location

1182.16.1115

Toronto, Ontario, Canada

Location

1182.16.1124

Toronto, Ontario, Canada

Location

1182.16.1106 Positive Care Clinic

Whitby, Ontario, Canada

Location

1182.16.1120 Metropolitan Campus

Windsor, Ontario, Canada

Location

1182.16.1116 Immune Deficiency Treatment Centre

Monteal, Quebec, Canada

Location

1182.16.1103 Hopital Notre Dame CHUM

Montreal, Quebec, Canada

Location

1182.16.1113 Montreal Chest Institute, McGill University Health Centre

Montreal, Quebec, Canada

Location

1182.16.1117 Clinique medicale l'Actuel

Montreal, Quebec, Canada

Location

1182.16.1119

Montreal, Quebec, Canada

Location

1182.16.1122 Infectious Diseases

Montreal, Quebec, Canada

Location

1182.16.1130 Clinique Medicale LORI

Montreal, Quebec, Canada

Location

1182.16.4501 Boehringer Ingelheim Investigational Site

Copenhagen, Denmark

Location

1182.16.4502 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1182.16.4504 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1182.16.3491 Boehringer Ingelheim Investigational Site

Vic (Barcelona), El Salvador

Location

1182.16.3464 Boehringer Ingelheim Investigational Site

Vizcaya, El Salvador

Location

1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas

Athens, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis

Athens, Greece

Location

1182.16.3010 University Hospital of Patras

Pátrai, Greece

Location

1182.16.3008 "Tzanio" Hospital

Piraeus, Greece

Location

1182.16.3009 AHEPA Hospital

Thessaloniki, Greece

Location

1182.16.3932 Azienda Ospedaliera Umberto I

Ancona, Italy

Location

1182.16.3923 Ospedale Santa Maria Annunziata

Antella (fi), Italy

Location

1182.16.3952 Centro di riferimento oncologico

Aviano - PD, Italy

Location

1182.16.3958 A.O. Ospedale Clinico Consorziale

Bari, Italy

Location

1182.16.3920 Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

1182.16.3946 Ospedale Policlinico S. Orsola Bologna

Bologna, Italy

Location

1182.16.3938 Ospedale Civile Regionale

Bolzano, Italy

Location

1182.16.3901 Università di Brescia

Brescia, Italy

Location

1182.16.3957 A.O. Spedali Civili di Brescia

Brescia, Italy

Location

1182.16.3928 Azienda Ospedaliera

Busto Arsizio (va), Italy

Location

1182.16.3964 Ospedale SS. Trinità

Cagliari, Italy

Location

1182.16.3947 U.O. Malattie Infettive

Catania, Italy

Location

1182.16.3961 Ospedale Pugliese

Catanzaro, Italy

Location

1182.16.3954 Ospedale Civile

Cuggiono-MI, Italy

Location

1182.16.3963 Azienda Ospedaliera Arcispedale S. Anna

Ferrara, Italy

Location

1182.16.3924 Azienda Ospedaliera Careggi

Florence, Italy

Location

1182.16.3902 Ospedali Riuniti di Foggia

Foggia, Italy

Location

1182.16.3911 U.O. di Malattie Infettive

Foggia, Italy

Location

1182.16.3926 Azienda Ospedaliera

Genova, Italy

Location

1182.16.3927 Azienda Ospedaliera

Genova, Italy

Location

1182.16.3929 Malattie Infettive

Genova, Italy

Location

1182.16.3912 Ospedale "A. Manzoni"

Lecco, Italy

Location

1182.16.3925 Azienda Ospedaliera Carlo Poma

Mantova, Italy

Location

1182.16.3951 Ospedale Civile Umberto I

Mestre-VE, Italy

Location

1182.16.3903 Ospedale L. Sacco

Milan, Italy

Location

1182.16.3904 Ospedale Luigi Sacco

Milan, Italy

Location

1182.16.3910 Ospedale Luigi Sacco

Milan, Italy

Location

1182.16.3913 Fondazione Centro S. Raffaele del Monte Tabor

Milan, Italy

Location

1182.16.3953 ospedale Niguarda

Milan, Italy

Location

1182.16.3965 Ospedale Maggiore

Milan, Italy

Location

1182.16.3968 Azienda Ospedaliera Policlinico

Modena, Italy

Location

1182.16.3934 Azienda Ospedaliera D. Cotugno

Napoli, Italy

Location

1182.16.3937 Azienda Ospedaliera D. Cotugno

Napoli, Italy

Location

1182.16.3942 Azienda Ospedaliera di Padova

Padua, Italy

Location

1182.16.3914 Presidio Ospedaliero di Verbania

Pallanza (Verbania), Italy

Location

1182.16.3948 U.O. Malattie Infettive ed Epatologia

Parma, Italy

Location

1182.16.3909 I.R.C.C.S. Policlinico San Matteo

Pavia, Italy

Location

1182.16.3921 IRCCS Policlinico San Matteo

Pavia, Italy

Location

1182.16.3966 Policlinico Monteluce

Perugia, Italy

Location

1182.16.3955 Ospedale San Salvatore

Pesaro, Italy

Location

1182.16.3967 Ospedale Civile dello Spirito Santo

Pescara, Italy

Location

1182.16.3944 Ospedale Cisanello

Pisa, Italy

Location

1182.16.3931 Ospedale Santa Maria delle Croci

Ravenna, Italy

Location

1182.16.3930 Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

1182.16.3905 IRCCS Lazzaro Spallanzani

Roma, Italy

Location

1182.16.3906 IRCCS Lazzaro Spallanzani

Roma, Italy

Location

1182.16.3907 IRCCS Lazzaro Spallanzani

Roma, Italy

Location

1182.16.3908 IRCCS Lazzaro Spallanzani

Roma, Italy

Location

1182.16.3915 Azienda Policlinico Umberto I

Roma, Italy

Location

1182.16.3922 Università "La Sapienza"

Roma, Italy

Location

1182.16.3941 Istituto Nazionale per le Malattie Infettive

Roma, Italy

Location

1182.16.3960 Università Cattolica del Sacro Cuore

Roma, Italy

Location

1182.16.3945 Istituto Malattie Infettive Università Di Sassari

Sassari, Italy

Location

1182.16.3970 Ospedale San Giuseppe Moscati

Statte (ta), Italy

Location

1182.16.3917 Ospedale Amedeo di Savoia

Torino, Italy

Location

1182.16.3918 Ospedale Amedeo di Savoia

Torino, Italy

Location

1182.16.3919 Ospedale Amedeo di Savoia

Torino, Italy

Location

1182.16.3933 Azienda Ospedaliera Umberto I

Torrette Di Ancona, Italy

Location

1182.16.3939 Ospedale Regionale

Torrette Di Ancona, Italy

Location

1182.16.3940 Presidio Ospedaliero Cà Foncello

Treviso, Italy

Location

1182.16.3943 Policlinico Universitario di Udine

Udine, Italy

Location

1182.16.3916 Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Location

1182.16.3950 Ospedale SS. Giovanni e Paolo

Venezia, Italy

Location

1182.16.3949 Policlinico Rossi "Borgo Roma"

Verona, Italy

Location

1182.16.3959 Ospedale Civile di Vicenza - USSL 6

Vicenza, Italy

Location

1182.16.3502 Hospital São Francisco Xavier

Lisbon, Portugal

Location

1182.16.3503 Centro Hospitalar de Lisboa

Lisbon, Portugal

Location

1182.16.3505 Hospital Santa Maria

Lisbon, Portugal

Location

1182.16.3501 Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Portugal

Location

1182.16.3504 Hospital Joaquim Urbano

Porto, Portugal

Location

1182.16.3419 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1182.16.3412 Boehringer Ingelheim Investigational Site

Alcalá de Henares (Madrid), Spain

Location

1182.16.3432 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1182.16.3484 Boehringer Ingelheim Investigational Site

Almería, Spain

Location

1182.16.3487 Boehringer Ingelheim Investigational Site

Arrecife (Lanzarote), Spain

Location

1182.16.3474 Boehringer Ingelheim Investigational Site

Aviles (Asturias), Spain

Location

1182.16.3440

Badalona, Spain

Location

1182.16.3454 Boehringer Ingelheim Investigational Site

Baracaldo (Vizcaya), Spain

Location

1182.16.3438 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.16.3442 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.16.3448 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.16.3449 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.16.3463 Boehringer Ingelheim Investigational Site

Bilbao, Spain

Location

1182.16.3476 Boehringer Ingelheim Investigational Site

Cadiz, Spain

Location

1182.16.3430 Boehringer Ingelheim Investigational Site

Cartagena, Spain

Location

1182.16.3462 Boehringer Ingelheim Investigational Site

Castellon, Spain

Location

1182.16.3429 Boehringer Ingelheim Investigational Site

Córdoba, Spain

Location

1182.16.3453 Boehringer Ingelheim Investigational Site

Donostia / San Sebastian, Spain

Location

1182.16.3431 Boehringer Ingelheim Investigational Site

El Palmar (murcia), Spain

Location

1182.16.3488 Boehringer Ingelheim Investigational Site

Gandia (Valencia), Spain

Location

1182.16.3411 Boehringer Ingelheim Investigational Site

Getafe (Madrid), Spain

Location

1182.16.3418 Boehringer Ingelheim Investigational Site

Gijón (asturias), Spain

Location

1182.16.3443 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

1182.16.3427 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

1182.16.3428 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

1182.16.3439 Boehringer Ingelheim Investigational Site

Granollers (Barcelona), Spain

Location

1182.16.3477 Boehringer Ingelheim Investigational Site

Hospitalet de Llobregat (Barcelona), Spain

Location

1182.16.3480 Boehringer Ingelheim Investigational Site

Huelva, Spain

Location

1182.16.3498 Boehringer Ingelheim Investigational Site

Ibiza Town, Spain

Location

1182.16.3479 Boehringer Ingelheim Investigational Site

Jaén, Spain

Location

1182.16.3423 Boehringer Ingelheim Investigational Site

Jerez de la Frontera, Spain

Location

1182.16.3445 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1182.16.3436 Boehringer Ingelheim Investigational Site

La Laguna (santa Cruz de Tenerife), Spain

Location

1182.16.3434 Boehringer Ingelheim Investigational Site

Las Palmas de Gran Canaria, Spain

Location

1182.16.3437 Boehringer Ingelheim Investigational Site

Las Palmas de Gran Canarias, Spain

Location

1182.16.3470 Boehringer Ingelheim Investigational Site

Leganés (Madrid), Spain

Location

1182.16.3441 Boehringer Ingelheim Investigational Site

Lleida, Spain

Location

1182.16.3490 Boehringer Ingelheim Investigational Site

Logroño, Spain

Location

1182.16.3401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3402 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3407 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3408 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3409 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3413 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.16.3494 Boehringer Ingelheim Investigational Site

Manresa (Barcelona), Spain

Location

1182.16.3426 Boehringer Ingelheim Investigational Site

Marbella (Málaga), Spain

Location

1182.16.3493 Boehringer Ingelheim Investigational Site

Mataró, Spain

Location

1182.16.3492

Mataró (Barcelona), Spain

Location

1182.16.3424 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1182.16.3425 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1182.16.3410 Boehringer Ingelheim Investigational Site

Móstoles (Madrid), Spain

Location

1182.16.3489 Boehringer Ingelheim Investigational Site

Navarra, Spain

Location

1182.16.3472 Boehringer Ingelheim Investigational Site

Ourense, Spain

Location

1182.16.3417 Boehringer Ingelheim Investigational Site

Oviedo (Asturias), Spain

Location

1182.16.3496 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

1182.16.3450 Boehringer Ingelheim Investigational Site

Plama de Mallorca, Spain

Location

1182.16.3497 Boehringer Ingelheim Investigational Site

Reus (Tarragona), Spain

Location

1182.16.3446 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), Spain

Location

1182.16.3435 Boehringer Ingelheim Investigational Site

Santa Cruz de Tenerife, Spain

Location

1182.16.3455 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1182.16.3415 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

1182.16.3420 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1182.16.3421 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1182.16.3422 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1182.16.3447 Boehringer Ingelheim Investigational Site

Tarragona, Spain

Location

1182.16.3495 Boehringer Ingelheim Investigational Site

Tarragona, Spain

Location

1182.16.3444 Boehringer Ingelheim Investigational Site

Terrassa, Spain

Location

1182.16.3456 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1182.16.3457 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1182.16.3458 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1182.16.3460 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1182.16.3461 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1182.16.3403 Boehringer Ingelheim Investigational Site

Valladolid, Spain

Location

1182.16.3416 Boehringer Ingelheim Investigational Site

Vigo, Spain

Location

1182.16.3467 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), Spain

Location

1182.16.3482 Boehringer Ingelheim Investigational Site

Villajoyosa (alicante), Spain

Location

1182.16.3483 Boehringer Ingelheim Investigational Site

Vitoria-Gasteiz, Spain

Location

1182.16.3471 Boehringer Ingelheim Investigational Site

Zamora, Spain

Location

1182.16.3451 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

1182.16.3452 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: May 1, 2004
• Primary Completion: June 1, 2008
• Last Updated: November 30, 2016

Record last verified: 2013-10

Locations

IT (65); BE (11); ES (83); DK (3); CA (26); PT (5); EL (2); GR (8); BR (12)