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Clinical Trials

MainTitle

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

This study has been approved for marketing
Sponsor
Boehringer Ingelheim


Information provided by (Responsible Party)
Boehringer Ingelheim
ClinicalTrials.gov Identifier
NCT00933205

First received: July 3, 2009
Last updated: November 29, 2016
Last Verified: October 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Drug : Tipranavir

Study Type: Expanded Access   What is Expanded Access?
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.

Further study details as provided by Boehringer Ingelheim:

Study Start Date: May 2004
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

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

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:
  • 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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00933205

    Locations

    Belgium
    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
    Brazil
    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
    Canada
    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
    Denmark
    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
    El Salvador
    1182.16.3491 Boehringer Ingelheim Investigational Site
    Vic (Barcelona), El Salvador
    1182.16.3464 Boehringer Ingelheim Investigational Site
    Vizcaya, El Salvador
    Greece
    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
    Italy
    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
    Portugal
    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
    Spain
    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

    Sponsors and Collaborators

    Boehringer Ingelheim

    Investigators

    Study Chair: Boehringer Ingelheim Boehringer Ingelheim
    More Information

    More Information


    Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim  
    ClinicalTrials.gov Identifier: NCT00933205   History of Changes  
    Other Study ID Numbers: 1182.16  
    Study First Received: July 3, 2009  
    Last Updated: November 29, 2016  

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    HIV Infections
    Ritonavir
    Tipranavir

    ClinicalTrials.gov processed this data on October 23, 2017
    This information is provided by ClinicalTrials.gov.