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Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tipranavir (with low dose ritonavir)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent prior to trial participation. Human immunodeficiency virus-1 infected males or females >=18 years of age. 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. 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. Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening. 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). Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system. 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: Antiretroviral medication naïve. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months. Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit. 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 Prior tipranavir use. 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.) Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2). Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Sites / Locations

  • 1182.48.5401 Fundación Huésped
  • 1182.48.5402 Fundación Huésped
  • 1182.48.5403 Servicio de Infecciosas
  • 1182.48.5404 Servicio de Infecciosas
  • 1182.48.5405 Hospital Muniz
  • 1182.48.5406 Servicio de Immunocomprometido
  • 1182.48.4301 Boehringer Ingelheim Investigational Site
  • 1182.48.3209 Boehringer Ingelheim Investigational Site
  • 1182.48.3201 Boehringer Ingelheim Investigational Site
  • 1182.48.3202 Boehringer Ingelheim Investigational Site
  • 1182.48.3206 Boehringer Ingelheim Investigational Site
  • 1182.48.3207 Boehringer Ingelheim Investigational Site
  • 1182.48.3210 Boehringer Ingelheim Investigational Site
  • 1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
  • 1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
  • 1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
  • 1182.48.5502 Fundação Oswaldo Cruz
  • 1182.48.5509 Universidade Federal do Rio de Janeiro
  • 1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
  • 1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
  • 1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
  • 1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
  • 1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
  • 1182.48.5508 I.I. Emilio Ribas
  • 1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
  • 1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
  • 1182.48.4505 Boehringer Ingelheim Investigational Site
  • 1182.48.4502 Boehringer Ingelheim Investigational Site
  • 1182.48.4501 Boehringer Ingelheim Investigational Site
  • 1182.48.4504 Boehringer Ingelheim Investigational Site
  • 1182.48.3311 Boehringer Ingelheim Investigational Site
  • 1182.48.3307 Boehringer Ingelheim Investigational Site
  • 1182.48.3317 Boehringer Ingelheim Investigational Site
  • 1182.48.3302 Boehringer Ingelheim Investigational Site
  • 1182.48.3303 Boehringer Ingelheim Investigational Site
  • 1182.48.3305 Boehringer Ingelheim Investigational Site
  • 1182.48.3304 Boehringer Ingelheim Investigational Site
  • 1182.48.3322 Boehringer Ingelheim Investigational Site
  • 1182.48.3308 Boehringer Ingelheim Investigational Site
  • 1182.48.3309 Boehringer Ingelheim Investigational Site
  • 1182.48.3318 Boehringer Ingelheim Investigational Site
  • 1182.48.3306 Boehringer Ingelheim Investigational Site
  • 1182.48.3316 Boehringer Ingelheim Investigational Site
  • 1182.48.3323 Boehringer Ingelheim Investigational Site
  • 1182.48.3301 Boehringer Ingelheim Investigational Site
  • 1182.48.3319 Boehringer Ingelheim Investigational Site
  • 1182.48.3310 Boehringer Ingelheim Investigational Site
  • 1182.48.3312 Boehringer Ingelheim Investigational Site
  • 1182.48.3321 Boehringer Ingelheim Investigational Site
  • 1182.48.3315 Boehringer Ingelheim Investigational Site
  • 1182.48.3313 Boehringer Ingelheim Investigational Site
  • 1182.48.3314 Boehringer Ingelheim Investigational Site
  • 1182.48.3320 Boehringer Ingelheim Investigational Site
  • 1182.48.4911 Boehringer Ingelheim Investigational Site
  • 1182.48.4901 Boehringer Ingelheim Investigational Site
  • 1182.48.4902 Boehringer Ingelheim Investigational Site
  • 1182.48.4903 Boehringer Ingelheim Investigational Site
  • 1182.48.4918 Boehringer Ingelheim Investigational Site
  • 1182.48.4906 Boehringer Ingelheim Investigational Site
  • 1182.48.4912 Boehringer Ingelheim Investigational Site
  • 1182.48.4914 Boehringer Ingelheim Investigational Site
  • 1182.48.4908 Boehringer Ingelheim Investigational Site
  • 1182.48.4904 Boehringer Ingelheim Investigational Site
  • 1182.48.4924 Boehringer Ingelheim Investigational Site
  • 1182.48.4930 Boehringer Ingelheim Investigational Site
  • 1182.48.4928 Boehringer Ingelheim Investigational Site
  • 1182.48.4916 Boehringer Ingelheim Investigational Site
  • 1182.48.4929 Boehringer Ingelheim Investigational Site
  • 1182.48.4931 Boehringer Ingelheim Investigational Site
  • 1182.48.4913 Boehringer Ingelheim Investigational Site
  • 1182.48.4920 Boehringer Ingelheim Investigational Site
  • 1182.48.4909 Boehringer Ingelheim Investigational Site
  • 1182.48.4905 Boehringer Ingelheim Investigational Site
  • 1182.48.4926 Boehringer Ingelheim Investigational Site
  • 1182.48.4923 Boehringer Ingelheim Investigational Site
  • 1182.48.4907 Boehringer Ingelheim Investigational Site
  • 1182.48.4910 Boehringer Ingelheim Investigational Site
  • 1182.48.4915 Boehringer Ingelheim Investigational Site
  • 1182.48.4919 Boehringer Ingelheim Investigational Site
  • 1182.48.4921 Boehringer Ingelheim Investigational Site
  • 1182.48.4927 Boehringer Ingelheim Investigational Site
  • 1182.48.3001 Boehringer Ingelheim Investigational Site
  • 1182.48.3002 Boehringer Ingelheim Investigational Site
  • 1182.48.3003 Boehringer Ingelheim Investigational Site
  • 1182.48.3004 Boehringer Ingelheim Investigational Site
  • 1182.48.3006 Boehringer Ingelheim Investigational Site
  • 1182.48.3007 Boehringer Ingelheim Investigational Site
  • 1182.48.3005 Boehringer Ingelheim Investigational Site
  • 1182.48.3010 Boehringer Ingelheim Investigational Site
  • 1182.48.3008 Boehringer Ingelheim Investigational Site
  • 1182.48.3009 Boehringer Ingelheim Investigational Site
  • 1182.48.3531 Boehringer Ingelheim Investigational Site
  • 1182.48.3930 Boehringer Ingelheim Investigational Site
  • 1182.48.3920 Boehringer Ingelheim Investigational Site
  • 1182.48.3926 Boehringer Ingelheim Investigational Site
  • 1182.48.3932 Boehringer Ingelheim Investigational Site
  • 1182.48.3908 Boehringer Ingelheim Investigational Site
  • 1182.48.3929 Boehringer Ingelheim Investigational Site
  • 1182.48.3917 Boehringer Ingelheim Investigational Site
  • 1182.48.3919 Boehringer Ingelheim Investigational Site
  • 1182.48.3905 Boehringer Ingelheim Investigational Site
  • 1182.48.3927 Boehringer Ingelheim Investigational Site
  • 1182.48.3925 Boehringer Ingelheim Investigational Site
  • 1182.48.3910 Boehringer Ingelheim Investigational Site
  • 1182.48.3901 Boehringer Ingelheim Investigational Site
  • 1182.48.3907 Boehringer Ingelheim Investigational Site
  • 1182.48.3924 Boehringer Ingelheim Investigational Site
  • 1182.48.3934 Boehringer Ingelheim Investigational Site
  • 1182.48.3915 Boehringer Ingelheim Investigational Site
  • 1182.48.3912 Boehringer Ingelheim Investigational Site
  • 1182.48.3921 Boehringer Ingelheim Investigational Site
  • 1182.48.3916 Boehringer Ingelheim Investigational Site
  • 1182.48.3922 Boehringer Ingelheim Investigational Site
  • 1182.48.3904 Boehringer Ingelheim Investigational Site
  • 1182.48.3902 Boehringer Ingelheim Investigational Site
  • 1182.48.3903 Boehringer Ingelheim Investigational Site
  • 1182.48.3909 Boehringer Ingelheim Investigational Site
  • 1182.48.3935 Boehringer Ingelheim Investigational Site
  • 1182.48.3906 Boehringer Ingelheim Investigational Site
  • 1182.48.3914 Boehringer Ingelheim Investigational Site
  • 1182.48.3931 Boehringer Ingelheim Investigational Site
  • 1182.48.3933 Boehringer Ingelheim Investigational Site
  • 1182.48.5201 Centro Médico La Raza IMSS
  • 1182.48.5202 Hospital Lopez Mateos
  • 1182.48.5203 Centro Guadalajara, Jal.
  • 1182.48.5206 Centro Medico San Vicente
  • 1182.48.3101 Boehringer Ingelheim Investigational Site
  • 1182.48.3106 Boehringer Ingelheim Investigational Site
  • 1182.48.3110 Boehringer Ingelheim Investigational Site
  • 1182.48.3108 Boehringer Ingelheim Investigational Site
  • 1182.48.3105 Boehringer Ingelheim Investigational Site
  • 1182.48.3104 Boehringer Ingelheim Investigational Site
  • 1182.48.3502 Boehringer Ingelheim Investigational Site
  • 1182.48.3503 Boehringer Ingelheim Investigational Site
  • 1182.48.3501 Boehringer Ingelheim Investigational Site
  • 1182.48.3505 Hospital Egas Moniz
  • 1182.48.3504 Hospital de São João
  • 1182.48.3415 Boehringer Ingelheim Investigational Site
  • 1182.48.3405 Boehringer Ingelheim Investigational Site
  • 1182.48.3401 Boehringer Ingelheim Investigational Site
  • 1182.48.3407 Boehringer Ingelheim Investigational Site
  • 1182.48.3408 Boehringer Ingelheim Investigational Site
  • 1182.48.3409 Boehringer Ingelheim Investigational Site
  • 1182.48.3406 Boehringer Ingelheim Investigational Site
  • 1182.48.3402 Boehringer Ingelheim Investigational Site
  • 1182.48.3403 Boehringer Ingelheim Investigational Site
  • 1182.48.3404 Boehringer Ingelheim Investigational Site
  • 1182.48.3410 Boehringer Ingelheim Investigational Site
  • 1182.48.3411 Boehringer Ingelheim Investigational Site
  • 1182.48.3412 Boehringer Ingelheim Investigational Site
  • 1182.48.3417 Boehringer Ingelheim Investigational Site
  • 1182.48.3416 Boehringer Ingelheim Investigational Site
  • 1182.48.3413 Boehringer Ingelheim Investigational Site
  • 1182.48.3414 Boehringer Ingelheim Investigational Site
  • 1182.48.3420 Boehringer Ingelheim Investigational Site
  • 1182.48.3418 Boehringer Ingelheim Investigational Site
  • 1182.48.4603 Boehringer Ingelheim Investigational Site
  • 1182.48.4602 Boehringer Ingelheim Investigational Site
  • 1182.48.4601 Boehringer Ingelheim Investigational Site
  • 1182.48.4101 Universitätsspital Basel
  • 1182.48.4104 Hopital Universitaire de Genève
  • 1182.48.4103 Kantonsspital St. Gallen
  • 1182.48.4102 Universitätsspital Zürich
  • 1182.48.4405 Boehringer Ingelheim Investigational Site
  • 1182.48.4412 Boehringer Ingelheim Investigational Site
  • 1182.48.4411 Boehringer Ingelheim Investigational Site
  • 1182.48.4404 Boehringer Ingelheim Investigational Site
  • 1182.48.4406 Boehringer Ingelheim Investigational Site
  • 1182.48.4408 Boehringer Ingelheim Investigational Site
  • 1182.48.4409 Boehringer Ingelheim Investigational Site
  • 1182.48.4414 Boehringer Ingelheim Investigational Site
  • 1182.48.4418 Boehringer Ingelheim Investigational Site
  • 1182.48.4417 Boehringer Ingelheim Investigational Site
  • 1182.48.4407 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Tipranavir(TPV)/low dose ritonavir(r)

Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Arm Description

Outcomes

Primary Outcome Measures

Treatment Response at Week 48
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time to Treatment Failure Through 48 Weeks of Treatment
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.

Secondary Outcome Measures

Treatment Response at Week 2
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 4
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 8
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 16
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 24
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 32
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 40
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 56
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 64
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 72
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 80
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 88
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 96
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time to Treatment Failure Through 96 Weeks of Treatment
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Virologic Response
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 2
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 4
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 8
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 16
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 24
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 32
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 40
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 48
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 56
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 64
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 72
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 80
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 88
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Virologic Response at Week 96
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Median Change From Baseline in Viral Load (Week 2)
Median Change From Baseline in Viral Load (Week 4)
Median Change From Baseline in Viral Load (Week 8)
Median Change From Baseline in Viral Load (Week 16)
Median Change From Baseline in Viral Load (Week 24)
Median Change From Baseline in Viral Load (Week 32)
Median Change From Baseline in Viral Load (Week 40)
Median Change From Baseline in Viral Load (Week 48)
Median Change From Baseline in Viral Load (Week 56)
Median Change From Baseline in Viral Load (Week 64)
Median Change From Baseline in Viral Load (Week 72)
Median Change From Baseline in Viral Load (Week 80)
Median Change From Baseline in Viral Load (Week 88)
Median Change From Baseline in Viral Load (Week 96)
Virologic Response at Week 40
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 2
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 4
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 8
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 16
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 24
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 32
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 48
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 56
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 64
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 72
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 80
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 88
Virologic response defined as Viral Load<400 copies/mL
Virologic Response at Week 96
Virologic response defined as Viral Load<400 copies/mL
Virologic Response
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 2
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 4
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 8
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 16
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 24
Viral Load < 50 copies/mL
Virologic Response at Week 32
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 40
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 48
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 56
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 64
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 72
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 80
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 88
Virologic response defined as Viral Load<50 copies/mL
Virologic Response at Week 96
Virologic response defined as Viral Load<50 copies/mL
Mean Change From Baseline in CD4+ Cell Count (Week 2)
Mean Change From Baseline in CD4+ Cell Count (Week 4)
Mean Change From Baseline in CD4+ Cell Count (Week 8)
Mean Change From Baseline in CD4+ Cell Count (Week 16)
Mean Change From Baseline in CD4+ Cell Count (Week 24)
Mean Change From Baseline in CD4+ Cell Count (Week 32)
Mean Change From Baseline in CD4+ Cell Count (Week 40)
Mean Change From Baseline in CD4+ Cell Count (Week 48)
Mean Change From Baseline in CD4+ Cell Count (Week 56)
Mean Change From Baseline in CD4+ Cell Count (Week 64)
Mean Change From Baseline in CD4+ Cell Count (Week 72)
Mean Change From Baseline in CD4+ Cell Count (Week 80)
Mean Change From Baseline in CD4+ Cell Count (Week 88)
Mean Change From Baseline in CD4+ Cell Count (Week 96)
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition. The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.

Full Information

First Posted
September 2, 2005
Last Updated
June 23, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144170
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
882 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tipranavir(TPV)/low dose ritonavir(r)
Arm Type
Other
Arm Title
Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Tipranavir (with low dose ritonavir)
Intervention Type
Drug
Intervention Name(s)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Primary Outcome Measure Information:
Title
Treatment Response at Week 48
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
after 48 weeks of treatment
Title
Time to Treatment Failure Through 48 Weeks of Treatment
Description
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Time Frame
after 48 weeks of treatment
Secondary Outcome Measure Information:
Title
Treatment Response at Week 2
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 2
Title
Treatment Response at Week 4
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 4
Title
Treatment Response at Week 8
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 8
Title
Treatment Response at Week 16
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 16
Title
Treatment Response at Week 24
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
Week 24
Title
Treatment Response at Week 32
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 32
Title
Treatment Response at Week 40
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 40
Title
Treatment Response at Week 56
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 56
Title
Treatment Response at Week 64
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 64
Title
Treatment Response at Week 72
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 72
Title
Treatment Response at Week 80
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 80
Title
Treatment Response at Week 88
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
week 88
Title
Treatment Response at Week 96
Description
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time Frame
after 96 weeks of treatment
Title
Time to Treatment Failure Through 96 Weeks of Treatment
Description
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Time Frame
after 96 weeks of treatment
Title
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Description
Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Time Frame
after 48 weeks of treatment
Title
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Description
Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Time Frame
after 96 weeks of treatment
Title
Virologic Response
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 2 through Week 96 (at any point during trial)
Title
Virologic Response at Week 2
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 2
Title
Virologic Response at Week 4
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 4
Title
Virologic Response at Week 8
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 8
Title
Virologic Response at Week 16
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 16
Title
Virologic Response at Week 24
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 24
Title
Virologic Response at Week 32
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 32
Title
Virologic Response at Week 40
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 40
Title
Virologic Response at Week 48
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 48
Title
Virologic Response at Week 56
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 56
Title
Virologic Response at Week 64
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
week 64
Title
Virologic Response at Week 72
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 72
Title
Virologic Response at Week 80
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 80
Title
Virologic Response at Week 88
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 88
Title
Virologic Response at Week 96
Description
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame
Week 96
Title
Median Change From Baseline in Viral Load (Week 2)
Time Frame
Baseline to Week 2
Title
Median Change From Baseline in Viral Load (Week 4)
Time Frame
Baseline to Week 4
Title
Median Change From Baseline in Viral Load (Week 8)
Time Frame
Baseline to Week 8
Title
Median Change From Baseline in Viral Load (Week 16)
Time Frame
Baseline to Week 16
Title
Median Change From Baseline in Viral Load (Week 24)
Time Frame
Baseline to Week 24
Title
Median Change From Baseline in Viral Load (Week 32)
Time Frame
Baseline to Week 32
Title
Median Change From Baseline in Viral Load (Week 40)
Time Frame
Baseline to Week 40
Title
Median Change From Baseline in Viral Load (Week 48)
Time Frame
Baseline to Week 48
Title
Median Change From Baseline in Viral Load (Week 56)
Time Frame
Baseline to Week 56
Title
Median Change From Baseline in Viral Load (Week 64)
Time Frame
Baseline to Week 64
Title
Median Change From Baseline in Viral Load (Week 72)
Time Frame
Baseline to Week 72
Title
Median Change From Baseline in Viral Load (Week 80)
Time Frame
Baseline to Week 80
Title
Median Change From Baseline in Viral Load (Week 88)
Time Frame
Baseline to Week 88
Title
Median Change From Baseline in Viral Load (Week 96)
Time Frame
Baseline to Week 96
Title
Virologic Response at Week 40
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 40
Title
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 2 through Week 96 (at any point during trial)
Title
Virologic Response at Week 2
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 2
Title
Virologic Response at Week 4
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 4
Title
Virologic Response at Week 8
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 8
Title
Virologic Response at Week 16
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 16
Title
Virologic Response at Week 24
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 24
Title
Virologic Response at Week 32
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 32
Title
Virologic Response at Week 48
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 48
Title
Virologic Response at Week 56
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 56
Title
Virologic Response at Week 64
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 64
Title
Virologic Response at Week 72
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 72
Title
Virologic Response at Week 80
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
Week 80
Title
Virologic Response at Week 88
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
week 88
Title
Virologic Response at Week 96
Description
Virologic response defined as Viral Load<400 copies/mL
Time Frame
week 96
Title
Virologic Response
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 2 through Week 96 (at any point during trial)
Title
Virologic Response at Week 2
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 2
Title
Virologic Response at Week 4
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 4
Title
Virologic Response at Week 8
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 8
Title
Virologic Response at Week 16
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 16
Title
Virologic Response at Week 24
Description
Viral Load < 50 copies/mL
Time Frame
Week 24
Title
Virologic Response at Week 32
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 32
Title
Virologic Response at Week 40
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 40
Title
Virologic Response at Week 48
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 48
Title
Virologic Response at Week 56
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 56
Title
Virologic Response at Week 64
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 64
Title
Virologic Response at Week 72
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 72
Title
Virologic Response at Week 80
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 80
Title
Virologic Response at Week 88
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 88
Title
Virologic Response at Week 96
Description
Virologic response defined as Viral Load<50 copies/mL
Time Frame
Week 96
Title
Mean Change From Baseline in CD4+ Cell Count (Week 2)
Time Frame
Baseline to Week 2
Title
Mean Change From Baseline in CD4+ Cell Count (Week 4)
Time Frame
Baseline to Week 4
Title
Mean Change From Baseline in CD4+ Cell Count (Week 8)
Time Frame
Baseline to Week 8
Title
Mean Change From Baseline in CD4+ Cell Count (Week 16)
Time Frame
Baseline to Week 16
Title
Mean Change From Baseline in CD4+ Cell Count (Week 24)
Time Frame
Baseline to Week 24
Title
Mean Change From Baseline in CD4+ Cell Count (Week 32)
Time Frame
Baseline to Week 32
Title
Mean Change From Baseline in CD4+ Cell Count (Week 40)
Time Frame
Baseline to Week 40
Title
Mean Change From Baseline in CD4+ Cell Count (Week 48)
Time Frame
Baseline to Week 48
Title
Mean Change From Baseline in CD4+ Cell Count (Week 56)
Time Frame
Baseline to Week 56
Title
Mean Change From Baseline in CD4+ Cell Count (Week 64)
Time Frame
Baseline to Week 64
Title
Mean Change From Baseline in CD4+ Cell Count (Week 72)
Time Frame
Baseline to Week 72
Title
Mean Change From Baseline in CD4+ Cell Count (Week 80)
Time Frame
Baseline to Week 80
Title
Mean Change From Baseline in CD4+ Cell Count (Week 88)
Time Frame
Baseline to Week 88
Title
Mean Change From Baseline in CD4+ Cell Count (Week 96)
Time Frame
Baseline to Week 96
Title
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Description
Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition. The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.
Time Frame
up to 75 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to trial participation. Human immunodeficiency virus-1 infected males or females >=18 years of age. 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. 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. Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening. 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). Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system. 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: Antiretroviral medication naïve. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months. Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit. 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 Prior tipranavir use. 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.) Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2). Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1182.48.5401 Fundación Huésped
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.5402 Fundación Huésped
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.5403 Servicio de Infecciosas
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.5404 Servicio de Infecciosas
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.5405 Hospital Muniz
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.5406 Servicio de Immunocomprometido
City
Buenos Aires
Country
Argentina
Facility Name
1182.48.4301 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1182.48.3209 Boehringer Ingelheim Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
1182.48.3201 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.48.3202 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.48.3206 Boehringer Ingelheim Investigational Site
City
Charleroi
Country
Belgium
Facility Name
1182.48.3207 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1182.48.3210 Boehringer Ingelheim Investigational Site
City
Luxembourg
Country
Belgium
Facility Name
1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
City
Campinas - SP
Country
Brazil
Facility Name
1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
City
Curitiba - PR
Country
Brazil
Facility Name
1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
City
Nova Iguaçu - RJ
Country
Brazil
Facility Name
1182.48.5502 Fundação Oswaldo Cruz
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1182.48.5509 Universidade Federal do Rio de Janeiro
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
City
Salvador - BA
Country
Brazil
Facility Name
1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5508 I.I. Emilio Ribas
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
City
São Paulo - SP
Country
Brazil
Facility Name
1182.48.4505 Boehringer Ingelheim Investigational Site
City
Aarhus N
Country
Denmark
Facility Name
1182.48.4502 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1182.48.4501 Boehringer Ingelheim Investigational Site
City
København Ø
Country
Denmark
Facility Name
1182.48.4504 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1182.48.3311 Boehringer Ingelheim Investigational Site
City
Besancon cedex
Country
France
Facility Name
1182.48.3307 Boehringer Ingelheim Investigational Site
City
Bordeaux cedex
Country
France
Facility Name
1182.48.3317 Boehringer Ingelheim Investigational Site
City
Bordeaux
Country
France
Facility Name
1182.48.3302 Boehringer Ingelheim Investigational Site
City
Caen
Country
France
Facility Name
1182.48.3303 Boehringer Ingelheim Investigational Site
City
Clamart
Country
France
Facility Name
1182.48.3305 Boehringer Ingelheim Investigational Site
City
Le Kremlin Bicetre
Country
France
Facility Name
1182.48.3304 Boehringer Ingelheim Investigational Site
City
Lyon cedex 02
Country
France
Facility Name
1182.48.3322 Boehringer Ingelheim Investigational Site
City
Lyon cedex 3
Country
France
Facility Name
1182.48.3308 Boehringer Ingelheim Investigational Site
City
Marseille cedex 5
Country
France
Facility Name
1182.48.3309 Boehringer Ingelheim Investigational Site
City
Marseille cedex 9
Country
France
Facility Name
1182.48.3318 Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1182.48.3306 Boehringer Ingelheim Investigational Site
City
Nice cedex 3
Country
France
Facility Name
1182.48.3316 Boehringer Ingelheim Investigational Site
City
Paris cedex 10
Country
France
Facility Name
1182.48.3323 Boehringer Ingelheim Investigational Site
City
Paris cedex 14
Country
France
Facility Name
1182.48.3301 Boehringer Ingelheim Investigational Site
City
Paris cedex 18
Country
France
Facility Name
1182.48.3319 Boehringer Ingelheim Investigational Site
City
Paris cedex 20
Country
France
Facility Name
1182.48.3310 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1182.48.3312 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1182.48.3321 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1182.48.3315 Boehringer Ingelheim Investigational Site
City
Rennes
Country
France
Facility Name
1182.48.3313 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1182.48.3314 Boehringer Ingelheim Investigational Site
City
Vandoeuvre les nancy
Country
France
Facility Name
1182.48.3320 Boehringer Ingelheim Investigational Site
City
Villejuif
Country
France
Facility Name
1182.48.4911 Boehringer Ingelheim Investigational Site
City
Aachen
Country
Germany
Facility Name
1182.48.4901 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1182.48.4902 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1182.48.4903 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
1182.48.4918 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1182.48.4906 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1182.48.4912 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1182.48.4914 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1182.48.4908 Boehringer Ingelheim Investigational Site
City
Erlangen
Country
Germany
Facility Name
1182.48.4904 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1182.48.4924 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
1182.48.4930 Boehringer Ingelheim Investigational Site
City
Freiburg/Breisgau
Country
Germany
Facility Name
1182.48.4928 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1182.48.4916 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1182.48.4929 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1182.48.4931 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1182.48.4913 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1182.48.4920 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1182.48.4909 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1182.48.4905 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1182.48.4926 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1182.48.4923 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1182.48.4907 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1182.48.4910 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1182.48.4915 Boehringer Ingelheim Investigational Site
City
Osnabrück
Country
Germany
Facility Name
1182.48.4919 Boehringer Ingelheim Investigational Site
City
Regensburg
Country
Germany
Facility Name
1182.48.4921 Boehringer Ingelheim Investigational Site
City
Stuttgart
Country
Germany
Facility Name
1182.48.4927 Boehringer Ingelheim Investigational Site
City
Stuttgart
Country
Germany
Facility Name
1182.48.3001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3002 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3003 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3004 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3006 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3007 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.48.3005 Boehringer Ingelheim Investigational Site
City
Goudi, Athens
Country
Greece
Facility Name
1182.48.3010 Boehringer Ingelheim Investigational Site
City
Patras
Country
Greece
Facility Name
1182.48.3008 Boehringer Ingelheim Investigational Site
City
Peraeus
Country
Greece
Facility Name
1182.48.3009 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1182.48.3531 Boehringer Ingelheim Investigational Site
City
Dublin 8
Country
Ireland
Facility Name
1182.48.3930 Boehringer Ingelheim Investigational Site
City
Ancona
Country
Italy
Facility Name
1182.48.3920 Boehringer Ingelheim Investigational Site
City
Antella (fi)
Country
Italy
Facility Name
1182.48.3926 Boehringer Ingelheim Investigational Site
City
Bari
Country
Italy
Facility Name
1182.48.3932 Boehringer Ingelheim Investigational Site
City
Bergamo
Country
Italy
Facility Name
1182.48.3908 Boehringer Ingelheim Investigational Site
City
Brescia
Country
Italy
Facility Name
1182.48.3929 Boehringer Ingelheim Investigational Site
City
Busto Arsizio (va)
Country
Italy
Facility Name
1182.48.3917 Boehringer Ingelheim Investigational Site
City
Ferrara
Country
Italy
Facility Name
1182.48.3919 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
1182.48.3905 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1182.48.3927 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1182.48.3925 Boehringer Ingelheim Investigational Site
City
Lecco
Country
Italy
Facility Name
1182.48.3910 Boehringer Ingelheim Investigational Site
City
Macerata
Country
Italy
Facility Name
1182.48.3901 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1182.48.3907 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1182.48.3924 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1182.48.3934 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1182.48.3915 Boehringer Ingelheim Investigational Site
City
Modena
Country
Italy
Facility Name
1182.48.3912 Boehringer Ingelheim Investigational Site
City
Napoli
Country
Italy
Facility Name
1182.48.3921 Boehringer Ingelheim Investigational Site
City
Padova
Country
Italy
Facility Name
1182.48.3916 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1182.48.3922 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1182.48.3904 Boehringer Ingelheim Investigational Site
City
Rimini
Country
Italy
Facility Name
1182.48.3902 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1182.48.3903 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1182.48.3909 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1182.48.3935 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1182.48.3906 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1182.48.3914 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1182.48.3931 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1182.48.3933 Boehringer Ingelheim Investigational Site
City
Treviso
Country
Italy
Facility Name
1182.48.5201 Centro Médico La Raza IMSS
City
Mexico, D.F.
Country
Mexico
Facility Name
1182.48.5202 Hospital Lopez Mateos
City
Mexico
Country
Mexico
Facility Name
1182.48.5203 Centro Guadalajara, Jal.
City
Mexico
Country
Mexico
Facility Name
1182.48.5206 Centro Medico San Vicente
City
Monterrey, N.l.
Country
Mexico
Facility Name
1182.48.3101 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1182.48.3106 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1182.48.3110 Boehringer Ingelheim Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
1182.48.3108 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1182.48.3105 Boehringer Ingelheim Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
1182.48.3104 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1182.48.3502 Boehringer Ingelheim Investigational Site
City
Cascais
Country
Portugal
Facility Name
1182.48.3503 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1182.48.3501 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1182.48.3505 Hospital Egas Moniz
City
Lisboa
Country
Portugal
Facility Name
1182.48.3504 Hospital de São João
City
Porto
Country
Portugal
Facility Name
1182.48.3415 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1182.48.3405 Boehringer Ingelheim Investigational Site
City
Badalona
Country
Spain
Facility Name
1182.48.3401 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.48.3407 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.48.3408 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.48.3409 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.48.3406 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
1182.48.3402 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3403 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3404 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3410 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3411 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3412 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.48.3417 Boehringer Ingelheim Investigational Site
City
Malaga
Country
Spain
Facility Name
1182.48.3416 Boehringer Ingelheim Investigational Site
City
San Sebastian
Country
Spain
Facility Name
1182.48.3413 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1182.48.3414 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.48.3420 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.48.3418 Boehringer Ingelheim Investigational Site
City
Vigo
Country
Spain
Facility Name
1182.48.4603 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1182.48.4602 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1182.48.4601 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1182.48.4101 Universitätsspital Basel
City
Basel
Country
Switzerland
Facility Name
1182.48.4104 Hopital Universitaire de Genève
City
Genève
Country
Switzerland
Facility Name
1182.48.4103 Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
1182.48.4102 Universitätsspital Zürich
City
Zürich
Country
Switzerland
Facility Name
1182.48.4405 Boehringer Ingelheim Investigational Site
City
Brighton
Country
United Kingdom
Facility Name
1182.48.4412 Boehringer Ingelheim Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
1182.48.4411 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
1182.48.4404 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4406 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4408 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4409 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4414 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4418 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.48.4417 Boehringer Ingelheim Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
1182.48.4407 Boehringer Ingelheim Investigational Site
City
Portsmouth
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20003457
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.
Results Reference
derived
PubMed Identifier
16890833
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.48_U09-3121-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.48_literature.pdf
Description
Related Info

Learn more about this trial

Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

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