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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT00933205
Other study ID # 1182.16
Secondary ID
Status Approved for marketing
Phase N/A
First received July 3, 2009
Last updated November 29, 2016
Start date May 2004

Study information

Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 ViennaBelgium: Federal Agency for Medicines and Health Products Department R&D EUROSTATION, Bloc II Place Victor Horta, 40 bte 40 - 8ème étage 1060 Bruxelles BelgiumBrazil: National Health Surveillance AgencyCanada: Ethics Review CommitteeDenmark:Finland:Great Britain:Greece: National Organization of MedicinesIreland:Italy: Ethics CommitteeNetherlands: Dutch Health Care InspectoratePortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of Medicines
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Tipranavir


Locations

Country Name City State
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
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 1182.16.5501 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
Canada 1182.16.1118 Calgary Alberta
Canada 1182.16.1104 University of Alberta H-Site Edmonton Alberta
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 1182.16.1131 The Moncton Hospital Moncton New Brunswick
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 1182.16.1132 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 1182.16.1101 St. Paul's Hospital Vancouver British Columbia
Canada 1182.16.1111 Downtown Infectious Diseases Clinic Vancouver British Columbia
Canada 1182.16.1106 Positive Care Clinic Whitby Ontario
Canada 1182.16.1120 Metropolitan Campus Windsor Ontario
Canada 1182.16.1125 St. Boniface General Hospital Winnipeg Manitoba
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
El Salvador 1182.16.3491 Boehringer Ingelheim Investigational Site Vic (Barcelona)
El Salvador 1182.16.3464 Boehringer Ingelheim Investigational Site Vizcaya
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
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
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
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 1182.16.3445 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 1182.16.3401 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 1182.16.3425 Boehringer Ingelheim Investigational Site Málaga
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 1182.16.3410 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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Brazil,  Canada,  Denmark,  El Salvador,  Greece,  Italy,  Portugal,  Spain, 

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