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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00933205
First received: July 3, 2009
Last updated: October 30, 2013
Last verified: October 2013
  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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  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
  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

  Hide Study Locations
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
1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras
Rio de Janeiro, Brazil
1182.16.5509
Rio de Janeiro - Rj, Brazil
1182.16.5510
Santos - Sp, Brazil
1182.16.5507 Hospital do Servidor Público Estadual de São Paulo
São Paulo - Sp, Brazil
1182.16.5506 Casa da AIDS da FMUSP
São Paulo - Sp, Brazil
1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
São Paulo - Sp, Brazil
1182.16.5508
Vila Mariana, Brazil
Canada, Alberta
1182.16.1118
Calgary, Alberta, Canada
1182.16.1104 University of Alberta H-Site
Edmonton, Alberta, Canada
Canada, British Columbia
1182.16.1101 St. Paul's Hospital
Vancouver, British Columbia, Canada
1182.16.1111 Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada
Canada, Manitoba
1182.16.1125 St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Canada, New Brunswick
1182.16.1131 The Moncton Hospital
Moncton, New Brunswick, Canada
Canada, Nova Scotia
1182.16.1128 Centre for Clinical Research
Halifax, Nova Scotia, Canada
Canada, Ontario
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
Canada, Quebec
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
1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis
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
1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas
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
1182.16.3927 Azienda Ospedaliera
Genova, Italy
1182.16.3929 Malattie Infettive
Genova, Italy
1182.16.3926 Azienda Ospedaliera
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
1182.16.3910 Ospedale Luigi Sacco
Milano, Italy
1182.16.3904 Ospedale Luigi Sacco
Milano, Italy
1182.16.3903 Ospedale L. 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
1182.16.3906 IRCCS Lazzaro Spallanzani
Roma, Italy
1182.16.3960 Università Cattolica del Sacro Cuore
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
1182.16.3905 IRCCS Lazzaro Spallanzani
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
1182.16.3449 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.16.3442 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.16.3448 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.16.3438 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
1182.16.3445 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain
1182.16.3477 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat (Barcelona), 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
1182.16.3434 Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canaria, Spain
1182.16.3437 Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canarias, 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
1182.16.3402 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.16.3413 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
1182.16.3401 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.16.3409 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.16.3408 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
1182.16.3416 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
1182.16.3471 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

Additional Information:
No publications provided

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: October 30, 2013
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products Department R&D EUROSTATION, Bloc II Place Victor Horta, 40 bte 40 - 8ème étage 1060 Bruxelles Belgium
Brazil: National Health Surveillance Agency
Canada: Ethics Review Committee
Denmark:
Finland:
Great Britain:
Greece: National Organization of Medicines
Ireland:
Italy: Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tipranavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014