Clinical trial NCT00144170: Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
Official title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 882
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to trial participation.
2. Human immunodeficiency virus-1 infected males or females \>=18 years of age.
3. Screening genotypic resistance report indicating both of the following:

   * at least one primary protease mutation at the following sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M , and
   * no more than two protease mutations on codons 33, 82, 84, or 90.
4. At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,

   * with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
   * current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.
5. Human immunodeficiency virus-1 viral load \>=1000 copies/mL at screening.
6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:

   * Total cholesterol \<=400 mg/dl or 10,36 mm/L.
   * Total triglycerides \<=750 mg/dl or 8,5 mm/L.
   * Alanine aminotransferase \<=3x upper limit of normal and aspartate aminotransferase \<=2.5x upper limit of normal.
   * Any Grade gamma-glutamyl transpeptidase is acceptable.
   * Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
   * All other laboratory test values \<= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).
7. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
9. A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).

Exclusion Criteria:

1. Antiretroviral medication naïve.
2. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
3. Alanine aminotransferase \>3x upper limit of normal and aspartate aminotransferase \>2.5x upper limit of normal at either screening visit.
4. Female patients of child-bearing potential who:

   * have a positive serum pregnancy test at screening or during the study,
   * are breast feeding
   * are planning to become pregnant, or
   * are not willing to use a barrier method of contraception, or
   * require ethinyl estradiol administration
5. Prior tipranavir use.
6. Use of investigational medications within 30 days before study entry or during the trial. (T-20 \[enfuvirtide\] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Primary outcomes:
measure: Treatment Response at Week 48
timeFrame: after 48 weeks of treatment
measure: Time to Treatment Failure Through 48 Weeks of Treatment
timeFrame: after 48 weeks of treatment
Secondary outcomes:
measure: Treatment Response at Week 2
timeFrame: week 2
measure: Treatment Response at Week 4
timeFrame: week 4
measure: Treatment Response at Week 8
timeFrame: week 8
measure: Treatment Response at Week 16
timeFrame: week 16
measure: Treatment Response at Week 24
timeFrame: Week 24
measure: Treatment Response at Week 32
timeFrame: week 32
measure: Treatment Response at Week 40
timeFrame: week 40
measure: Treatment Response at Week 56
timeFrame: week 56
measure: Treatment Response at Week 64
timeFrame: week 64
measure: Treatment Response at Week 72
timeFrame: week 72
measure: Treatment Response at Week 80
timeFrame: week 80
measure: Treatment Response at Week 88
timeFrame: week 88
measure: Treatment Response at Week 96
timeFrame: after 96 weeks of treatment
measure: Time to Treatment Failure Through 96 Weeks of Treatment
timeFrame: after 96 weeks of treatment
measure: Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
timeFrame: after 48 weeks of treatment
measure: Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
timeFrame: after 96 weeks of treatment
measure: Virologic Response
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response at Week 2
timeFrame: Week 2
measure: Virologic Response at Week 4
timeFrame: week 4
measure: Virologic Response at Week 8
timeFrame: week 8
measure: Virologic Response at Week 16
timeFrame: week 16
measure: Virologic Response at Week 24
timeFrame: week 24
measure: Virologic Response at Week 32
timeFrame: week 32
measure: Virologic Response at Week 40
timeFrame: week 40
measure: Virologic Response at Week 48
timeFrame: week 48
measure: Virologic Response at Week 56
timeFrame: week 56
measure: Virologic Response at Week 64
timeFrame: week 64
measure: Virologic Response at Week 72
timeFrame: Week 72
measure: Virologic Response at Week 80
timeFrame: Week 80
measure: Virologic Response at Week 88
timeFrame: Week 88
measure: Virologic Response at Week 96
timeFrame: Week 96
measure: Median Change From Baseline in Viral Load (Week 2)
timeFrame: Baseline to Week 2
measure: Median Change From Baseline in Viral Load (Week 4)
timeFrame: Baseline to Week 4
measure: Median Change From Baseline in Viral Load (Week 8)
timeFrame: Baseline to Week 8
measure: Median Change From Baseline in Viral Load (Week 16)
timeFrame: Baseline to Week 16
measure: Median Change From Baseline in Viral Load (Week 24)
timeFrame: Baseline to Week 24
measure: Median Change From Baseline in Viral Load (Week 32)
timeFrame: Baseline to Week 32
measure: Median Change From Baseline in Viral Load (Week 40)
timeFrame: Baseline to Week 40
measure: Median Change From Baseline in Viral Load (Week 48)
timeFrame: Baseline to Week 48
measure: Median Change From Baseline in Viral Load (Week 56)
timeFrame: Baseline to Week 56
measure: Median Change From Baseline in Viral Load (Week 64)
timeFrame: Baseline to Week 64
measure: Median Change From Baseline in Viral Load (Week 72)
timeFrame: Baseline to Week 72
measure: Median Change From Baseline in Viral Load (Week 80)
timeFrame: Baseline to Week 80
measure: Median Change From Baseline in Viral Load (Week 88)
timeFrame: Baseline to Week 88
measure: Median Change From Baseline in Viral Load (Week 96)
timeFrame: Baseline to Week 96
measure: Virologic Response at Week 40
timeFrame: Week 40
measure: Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response at Week 2
timeFrame: Week 2
measure: Virologic Response at Week 4
timeFrame: Week 4
measure: Virologic Response at Week 8
timeFrame: Week 8
measure: Virologic Response at Week 16
timeFrame: Week 16
measure: Virologic Response at Week 24
timeFrame: Week 24
measure: Virologic Response at Week 32
timeFrame: Week 32
measure: Virologic Response at Week 48
timeFrame: Week 48
measure: Virologic Response at Week 56
timeFrame: Week 56
measure: Virologic Response at Week 64
timeFrame: Week 64
measure: Virologic Response at Week 72
timeFrame: Week 72
measure: Virologic Response at Week 80
timeFrame: Week 80
measure: Virologic Response at Week 88
timeFrame: week 88
measure: Virologic Response at Week 96
timeFrame: week 96
measure: Virologic Response
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response at Week 2
timeFrame: Week 2
measure: Virologic Response at Week 4
timeFrame: Week 4
measure: Virologic Response at Week 8
timeFrame: Week 8
measure: Virologic Response at Week 16
timeFrame: Week 16
measure: Virologic Response at Week 24
timeFrame: Week 24
measure: Virologic Response at Week 32
timeFrame: Week 32
measure: Virologic Response at Week 40
timeFrame: Week 40
measure: Virologic Response at Week 48
timeFrame: Week 48
measure: Virologic Response at Week 56
timeFrame: Week 56
measure: Virologic Response at Week 64
timeFrame: Week 64
measure: Virologic Response at Week 72
timeFrame: Week 72
measure: Virologic Response at Week 80
timeFrame: Week 80
measure: Virologic Response at Week 88
timeFrame: Week 88
measure: Virologic Response at Week 96
timeFrame: Week 96
measure: Mean Change From Baseline in CD4+ Cell Count (Week 2)
timeFrame: Baseline to Week 2
measure: Mean Change From Baseline in CD4+ Cell Count (Week 4)
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in CD4+ Cell Count (Week 8)
timeFrame: Baseline to Week 8
measure: Mean Change From Baseline in CD4+ Cell Count (Week 16)
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline in CD4+ Cell Count (Week 24)
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline in CD4+ Cell Count (Week 32)
timeFrame: Baseline to Week 32
measure: Mean Change From Baseline in CD4+ Cell Count (Week 40)
timeFrame: Baseline to Week 40
measure: Mean Change From Baseline in CD4+ Cell Count (Week 48)
timeFrame: Baseline to Week 48
measure: Mean Change From Baseline in CD4+ Cell Count (Week 56)
timeFrame: Baseline to Week 56
measure: Mean Change From Baseline in CD4+ Cell Count (Week 64)
timeFrame: Baseline to Week 64
measure: Mean Change From Baseline in CD4+ Cell Count (Week 72)
timeFrame: Baseline to Week 72
measure: Mean Change From Baseline in CD4+ Cell Count (Week 80)
timeFrame: Baseline to Week 80
measure: Mean Change From Baseline in CD4+ Cell Count (Week 88)
timeFrame: Baseline to Week 88
measure: Mean Change From Baseline in CD4+ Cell Count (Week 96)
timeFrame: Baseline to Week 96
measure: Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
timeFrame: up to 75 weeks of treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: 1182.48.5401 Fundación Huésped
city: Buenos Aires
country: Argentina
facility: 1182.48.5402 Fundación Huésped
city: Buenos Aires
country: Argentina
facility: 1182.48.5403 Servicio de Infecciosas
city: Buenos Aires
country: Argentina
facility: 1182.48.5404 Servicio de Infecciosas
city: Buenos Aires
country: Argentina
facility: 1182.48.5405 Hospital Muniz
city: Buenos Aires
country: Argentina
facility: 1182.48.5406 Servicio de Immunocomprometido
city: Wien
country: Austria
facility: 1182.48.4301 Boehringer Ingelheim Investigational Site
city: Antwerpen
country: Belgium
facility: 1182.48.3209 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1182.48.3201 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1182.48.3202 Boehringer Ingelheim Investigational Site
city: Charleroi
country: Belgium
facility: 1182.48.3206 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1182.48.3207 Boehringer Ingelheim Investigational Site
city: Luxembourg
country: Belgium
facility: 1182.48.3210 Boehringer Ingelheim Investigational Site
city: Campinas - SP
country: Brazil
facility: 1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
city: Curitiba - PR
country: Brazil
facility: 1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
city: Nova Iguaçu - RJ
country: Brazil
facility: 1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
city: Rio de Janeiro - RJ
country: Brazil
facility: 1182.48.5502 Fundação Oswaldo Cruz
city: Rio de Janeiro - RJ
country: Brazil
facility: 1182.48.5509 Universidade Federal do Rio de Janeiro
city: Salvador - BA
country: Brazil
facility: 1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
city: São Paulo - SP
country: Brazil
facility: 1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
city: São Paulo - SP
country: Brazil
facility: 1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
city: São Paulo - SP
country: Brazil
facility: 1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
city: São Paulo - SP
country: Brazil
facility: 1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
city: São Paulo - SP
country: Brazil
facility: 1182.48.5508 I.I. Emilio Ribas
city: São Paulo - SP
country: Brazil
facility: 1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
city: São Paulo - SP
country: Brazil
facility: 1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
city: Aarhus N
country: Denmark
facility: 1182.48.4505 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1182.48.4502 Boehringer Ingelheim Investigational Site
city: København Ø
country: Denmark
facility: 1182.48.4501 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1182.48.4504 Boehringer Ingelheim Investigational Site
city: Besancon cedex
country: France
facility: 1182.48.3311 Boehringer Ingelheim Investigational Site
city: Bordeaux cedex
country: France
facility: 1182.48.3307 Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: 1182.48.3317 Boehringer Ingelheim Investigational Site
city: Caen
country: France
facility: 1182.48.3302 Boehringer Ingelheim Investigational Site
city: Clamart
country: France
facility: 1182.48.3303 Boehringer Ingelheim Investigational Site
city: Le Kremlin Bicetre
country: France
facility: 1182.48.3305 Boehringer Ingelheim Investigational Site
city: Lyon cedex 02
country: France
facility: 1182.48.3304 Boehringer Ingelheim Investigational Site
city: Lyon cedex 3
country: France
facility: 1182.48.3322 Boehringer Ingelheim Investigational Site
city: Marseille cedex 5
country: France
facility: 1182.48.3308 Boehringer Ingelheim Investigational Site
city: Marseille cedex 9
country: France
facility: 1182.48.3309 Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1182.48.3318 Boehringer Ingelheim Investigational Site
city: Nice cedex 3
country: France
facility: 1182.48.3306 Boehringer Ingelheim Investigational Site
city: Paris cedex 10
country: France
facility: 1182.48.3316 Boehringer Ingelheim Investigational Site
city: Paris cedex 14
country: France
facility: 1182.48.3323 Boehringer Ingelheim Investigational Site
city: Paris cedex 18
country: France
facility: 1182.48.3301 Boehringer Ingelheim Investigational Site
city: Paris cedex 20
country: France
facility: 1182.48.3319 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1182.48.3310 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1182.48.3312 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1182.48.3321 Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 1182.48.3315 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1182.48.3313 Boehringer Ingelheim Investigational Site
city: Vandoeuvre les nancy
country: France
facility: 1182.48.3314 Boehringer Ingelheim Investigational Site
city: Villejuif
country: France
facility: 1182.48.3320 Boehringer Ingelheim Investigational Site
city: Aachen
country: Germany
facility: 1182.48.4911 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1182.48.4901 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1182.48.4902 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 1182.48.4903 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1182.48.4918 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1182.48.4906 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1182.48.4912 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1182.48.4914 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1182.48.4908 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1182.48.4904 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 1182.48.4924 Boehringer Ingelheim Investigational Site
city: Freiburg/Breisgau
country: Germany
facility: 1182.48.4930 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1182.48.4928 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1182.48.4916 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1182.48.4929 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1182.48.4931 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1182.48.4913 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1182.48.4920 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1182.48.4909 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1182.48.4905 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1182.48.4926 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1182.48.4923 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1182.48.4907 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1182.48.4910 Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: 1182.48.4915 Boehringer Ingelheim Investigational Site
city: Regensburg
country: Germany
facility: 1182.48.4919 Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: 1182.48.4921 Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: 1182.48.4927 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3002 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3003 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3004 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3006 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.48.3007 Boehringer Ingelheim Investigational Site
city: Goudi, Athens
country: Greece
facility: 1182.48.3005 Boehringer Ingelheim Investigational Site
city: Patras
country: Greece
facility: 1182.48.3010 Boehringer Ingelheim Investigational Site
city: Peraeus
country: Greece
facility: 1182.48.3008 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1182.48.3009 Boehringer Ingelheim Investigational Site
city: Dublin 8
country: Ireland
facility: 1182.48.3531 Boehringer Ingelheim Investigational Site
city: Ancona
country: Italy
facility: 1182.48.3930 Boehringer Ingelheim Investigational Site
city: Antella (fi)
country: Italy
facility: 1182.48.3920 Boehringer Ingelheim Investigational Site
city: Bari
country: Italy
facility: 1182.48.3926 Boehringer Ingelheim Investigational Site
city: Bergamo
country: Italy
facility: 1182.48.3932 Boehringer Ingelheim Investigational Site
city: Brescia
country: Italy
facility: 1182.48.3908 Boehringer Ingelheim Investigational Site
city: Busto Arsizio (va)
country: Italy
facility: 1182.48.3929 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1182.48.3917 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 1182.48.3919 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1182.48.3905 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1182.48.3927 Boehringer Ingelheim Investigational Site
city: Lecco
country: Italy
facility: 1182.48.3925 Boehringer Ingelheim Investigational Site
city: Macerata
country: Italy
facility: 1182.48.3910 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1182.48.3901 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1182.48.3907 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1182.48.3924 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1182.48.3934 Boehringer Ingelheim Investigational Site
city: Modena
country: Italy
facility: 1182.48.3915 Boehringer Ingelheim Investigational Site
city: Napoli
country: Italy
facility: 1182.48.3912 Boehringer Ingelheim Investigational Site
city: Padova
country: Italy
facility: 1182.48.3921 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 1182.48.3916 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 1182.48.3922 Boehringer Ingelheim Investigational Site
city: Rimini
country: Italy
facility: 1182.48.3904 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1182.48.3902 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1182.48.3903 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1182.48.3909 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1182.48.3935 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1182.48.3906 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1182.48.3914 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1182.48.3931 Boehringer Ingelheim Investigational Site
city: Treviso
country: Italy
facility: 1182.48.3933 Boehringer Ingelheim Investigational Site
city: Mexico, D.F.
country: Mexico
facility: 1182.48.5201 Centro Médico La Raza IMSS
city: Mexico
country: Mexico
facility: 1182.48.5202 Hospital Lopez Mateos
city: Mexico
country: Mexico
facility: 1182.48.5203 Centro Guadalajara, Jal.
city: Monterrey, N.l.
country: Mexico
facility: 1182.48.5206 Centro Medico San Vicente
city: Amsterdam
country: Netherlands
facility: 1182.48.3101 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1182.48.3106 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 1182.48.3110 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1182.48.3108 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1182.48.3105 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1182.48.3104 Boehringer Ingelheim Investigational Site
city: Cascais
country: Portugal
facility: 1182.48.3502 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1182.48.3503 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1182.48.3501 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1182.48.3505 Hospital Egas Moniz
city: Porto
country: Portugal
facility: 1182.48.3504 Hospital de São João
city: Alicante
country: Spain
facility: 1182.48.3415 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1182.48.3405 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1182.48.3401 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1182.48.3407 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1182.48.3408 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1182.48.3409 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1182.48.3406 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3402 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3403 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3404 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3410 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3411 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1182.48.3412 Boehringer Ingelheim Investigational Site
city: Malaga
country: Spain
facility: 1182.48.3417 Boehringer Ingelheim Investigational Site
city: San Sebastian
country: Spain
facility: 1182.48.3416 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1182.48.3413 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1182.48.3414 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1182.48.3420 Boehringer Ingelheim Investigational Site
city: Vigo
country: Spain
facility: 1182.48.3418 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1182.48.4603 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1182.48.4602 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1182.48.4601 Boehringer Ingelheim Investigational Site
city: Basel
country: Switzerland
facility: 1182.48.4101 Universitätsspital Basel
city: Genève
country: Switzerland
facility: 1182.48.4104 Hopital Universitaire de Genève
city: St. Gallen
country: Switzerland
facility: 1182.48.4103 Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: 1182.48.4102 Universitätsspital Zürich
city: Brighton
country: United Kingdom
facility: 1182.48.4405 Boehringer Ingelheim Investigational Site
city: Edinburgh
country: United Kingdom
facility: 1182.48.4412 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 1182.48.4411 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4404 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4406 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4408 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4409 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4414 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.48.4418 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1182.48.4417 Boehringer Ingelheim Investigational Site
city: Portsmouth
country: United Kingdom
facility: 1182.48.4407 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203.
citation: Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75. doi: 10.1016/S0140-6736(06)69154-X.