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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144170
First received: September 2, 2005
Last updated: June 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir (with low dose ritonavir)
Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Treatment Response at Week 48 [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    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 Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 40 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 72 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 80 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    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 Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    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 Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    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 Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 40 [ Time Frame: week 40 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 56 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Median Change From Baseline in Viral Load (Week 2) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 4) [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 8) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 16) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 24) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 32) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 40) [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 48) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 56) [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 64) [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 72) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 80) [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 88) [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 96) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Virologic Response at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 96 [ Time Frame: week 96 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Viral Load < 50 copies/mL

  • Virologic Response at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Mean Change From Baseline in CD4+ Cell Count (Week 2) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 4) [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 8) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 16) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 24) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 32) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 40) [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 48) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 56) [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 64) [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 72) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 80) [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 88) [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 96) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. [ Time Frame: up to 75 weeks of treatment ] [ Designated as safety issue: No ]

    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.



Enrollment: 882
Study Start Date: February 2003
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tipranavir(TPV)/low dose ritonavir(r) Drug: Tipranavir (with low dose ritonavir)
Comparator protease inhibitor(CPI)/low dose ritonavir(r) Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144170

  Hide Study Locations
Locations
Argentina
1182.48.5403 Servicio de Infecciosas
Buenos Aires, Argentina
1182.48.5406 Servicio de Immunocomprometido
Buenos Aires, Argentina
1182.48.5404 Servicio de Infecciosas
Buenos Aires, Argentina
1182.48.5401 Fundación Huésped
Buenos Aires, Argentina
1182.48.5402 Fundación Huésped
Buenos Aires, Argentina
1182.48.5405 Hospital Muniz
Buenos Aires, Argentina
Austria
1182.48.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1182.48.3209 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
1182.48.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1182.48.3202 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1182.48.3206 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
1182.48.3207 Boehringer Ingelheim Investigational Site
Gent, Belgium
1182.48.3210 Boehringer Ingelheim Investigational Site
Luxembourg, Belgium
Brazil
1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
Campinas - SP, Brazil
1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
Curitiba - PR, Brazil
1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
Nova Iguaçu - RJ, Brazil
1182.48.5509 Universidade Federal do Rio de Janeiro
Rio de Janeiro - RJ, Brazil
1182.48.5502 Fundação Oswaldo Cruz
Rio de Janeiro - RJ, Brazil
1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
Salvador - BA, Brazil
1182.48.5508 I.I. Emilio Ribas
São Paulo - SP, Brazil
1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo - SP, Brazil
1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
São Paulo - SP, Brazil
1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
São Paulo - SP, Brazil
1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
São Paulo - SP, Brazil
1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
São Paulo - SP, Brazil
1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
São Paulo - SP, Brazil
Denmark
1182.48.4505 Boehringer Ingelheim Investigational Site
Aarhus N, Denmark
1182.48.4502 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1182.48.4501 Boehringer Ingelheim Investigational Site
København Ø, Denmark
1182.48.4504 Boehringer Ingelheim Investigational Site
Odense C, Denmark
France
1182.48.3311 Boehringer Ingelheim Investigational Site
Besancon cedex, France
1182.48.3317 Boehringer Ingelheim Investigational Site
Bordeaux, France
1182.48.3307 Boehringer Ingelheim Investigational Site
Bordeaux cedex, France
1182.48.3302 Boehringer Ingelheim Investigational Site
Caen, France
1182.48.3303 Boehringer Ingelheim Investigational Site
Clamart, France
1182.48.3305 Boehringer Ingelheim Investigational Site
Le Kremlin Bicetre, France
1182.48.3304 Boehringer Ingelheim Investigational Site
Lyon cedex 02, France
1182.48.3322 Boehringer Ingelheim Investigational Site
Lyon cedex 3, France
1182.48.3308 Boehringer Ingelheim Investigational Site
Marseille cedex 5, France
1182.48.3309 Boehringer Ingelheim Investigational Site
Marseille cedex 9, France
1182.48.3318 Boehringer Ingelheim Investigational Site
Nantes, France
1182.48.3306 Boehringer Ingelheim Investigational Site
Nice cedex 3, France
1182.48.3321 Boehringer Ingelheim Investigational Site
Paris, France
1182.48.3312 Boehringer Ingelheim Investigational Site
Paris, France
1182.48.3310 Boehringer Ingelheim Investigational Site
Paris, France
1182.48.3316 Boehringer Ingelheim Investigational Site
Paris cedex 10, France
1182.48.3323 Boehringer Ingelheim Investigational Site
Paris cedex 14, France
1182.48.3301 Boehringer Ingelheim Investigational Site
Paris cedex 18, France
1182.48.3319 Boehringer Ingelheim Investigational Site
Paris cedex 20, France
1182.48.3315 Boehringer Ingelheim Investigational Site
Rennes, France
1182.48.3313 Boehringer Ingelheim Investigational Site
Strasbourg, France
1182.48.3314 Boehringer Ingelheim Investigational Site
Vandoeuvre les nancy, France
1182.48.3320 Boehringer Ingelheim Investigational Site
Villejuif, France
Germany
1182.48.4911 Boehringer Ingelheim Investigational Site
Aachen, Germany
1182.48.4901 Boehringer Ingelheim Investigational Site
Berlin, Germany
1182.48.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1182.48.4903 Boehringer Ingelheim Investigational Site
Bochum, Germany
1182.48.4918 Boehringer Ingelheim Investigational Site
Bonn, Germany
1182.48.4906 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1182.48.4912 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1182.48.4914 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1182.48.4908 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1182.48.4904 Boehringer Ingelheim Investigational Site
Essen, Germany
1182.48.4924 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1182.48.4928 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1182.48.4930 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1182.48.4929 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1182.48.4931 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1182.48.4916 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1182.48.4913 Boehringer Ingelheim Investigational Site
Hannover, Germany
1182.48.4920 Boehringer Ingelheim Investigational Site
Hannover, Germany
1182.48.4909 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1182.48.4905 Boehringer Ingelheim Investigational Site
Köln, Germany
1182.48.4926 Boehringer Ingelheim Investigational Site
Köln, Germany
1182.48.4923 Boehringer Ingelheim Investigational Site
Mannheim, Germany
1182.48.4907 Boehringer Ingelheim Investigational Site
München, Germany
1182.48.4910 Boehringer Ingelheim Investigational Site
München, Germany
1182.48.4915 Boehringer Ingelheim Investigational Site
Osnabrück, Germany
1182.48.4919 Boehringer Ingelheim Investigational Site
Regensburg, Germany
1182.48.4921 Boehringer Ingelheim Investigational Site
Stuttgart, Germany
1182.48.4927 Boehringer Ingelheim Investigational Site
Stuttgart, Germany
Greece
1182.48.3002 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3003 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3007 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3001 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3006 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3004 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.48.3005 Boehringer Ingelheim Investigational Site
Goudi, Athens, Greece
1182.48.3010 Boehringer Ingelheim Investigational Site
Patras, Greece
1182.48.3008 Boehringer Ingelheim Investigational Site
Peraeus, Greece
1182.48.3009 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Ireland
1182.48.3531 Boehringer Ingelheim Investigational Site
Dublin 8, Ireland
Italy
1182.48.3930 Boehringer Ingelheim Investigational Site
Ancona, Italy
1182.48.3920 Boehringer Ingelheim Investigational Site
Antella (fi), Italy
1182.48.3926 Boehringer Ingelheim Investigational Site
Bari, Italy
1182.48.3932 Boehringer Ingelheim Investigational Site
Bergamo, Italy
1182.48.3908 Boehringer Ingelheim Investigational Site
Brescia, Italy
1182.48.3929 Boehringer Ingelheim Investigational Site
Busto Arsizio (va), Italy
1182.48.3917 Boehringer Ingelheim Investigational Site
Ferrara, Italy
1182.48.3919 Boehringer Ingelheim Investigational Site
Firenze, Italy
1182.48.3927 Boehringer Ingelheim Investigational Site
Genova, Italy
1182.48.3905 Boehringer Ingelheim Investigational Site
Genova, Italy
1182.48.3925 Boehringer Ingelheim Investigational Site
Lecco, Italy
1182.48.3910 Boehringer Ingelheim Investigational Site
Macerata, Italy
1182.48.3924 Boehringer Ingelheim Investigational Site
Milano, Italy
1182.48.3901 Boehringer Ingelheim Investigational Site
Milano, Italy
1182.48.3907 Boehringer Ingelheim Investigational Site
Milano, Italy
1182.48.3934 Boehringer Ingelheim Investigational Site
Milano, Italy
1182.48.3915 Boehringer Ingelheim Investigational Site
Modena, Italy
1182.48.3912 Boehringer Ingelheim Investigational Site
Napoli, Italy
1182.48.3921 Boehringer Ingelheim Investigational Site
Padova, Italy
1182.48.3916 Boehringer Ingelheim Investigational Site
Pavia, Italy
1182.48.3922 Boehringer Ingelheim Investigational Site
Pavia, Italy
1182.48.3904 Boehringer Ingelheim Investigational Site
Rimini, Italy
1182.48.3903 Boehringer Ingelheim Investigational Site
Roma, Italy
1182.48.3909 Boehringer Ingelheim Investigational Site
Roma, Italy
1182.48.3902 Boehringer Ingelheim Investigational Site
Roma, Italy
1182.48.3935 Boehringer Ingelheim Investigational Site
Roma, Italy
1182.48.3914 Boehringer Ingelheim Investigational Site
Torino, Italy
1182.48.3906 Boehringer Ingelheim Investigational Site
Torino, Italy
1182.48.3931 Boehringer Ingelheim Investigational Site
Torino, Italy
1182.48.3933 Boehringer Ingelheim Investigational Site
Treviso, Italy
Mexico
1182.48.5203 Centro Guadalajara, Jal.
Mexico, Mexico
1182.48.5202 Hospital Lopez Mateos
Mexico, Mexico
1182.48.5201 Centro Médico La Raza IMSS
Mexico, D.F., Mexico
1182.48.5206 Centro Medico San Vicente
Monterrey, N.l., Mexico
Netherlands
1182.48.3106 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1182.48.3101 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1182.48.3110 Boehringer Ingelheim Investigational Site
Den Haag, Netherlands
1182.48.3108 Boehringer Ingelheim Investigational Site
Groningen, Netherlands
1182.48.3105 Boehringer Ingelheim Investigational Site
Nijmegen, Netherlands
1182.48.3104 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Portugal
1182.48.3502 Boehringer Ingelheim Investigational Site
Cascais, Portugal
1182.48.3503 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1182.48.3501 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1182.48.3505 Hospital Egas Moniz
Lisboa, Portugal
1182.48.3504 Hospital de São João
Porto, Portugal
Spain
1182.48.3415 Boehringer Ingelheim Investigational Site
Alicante, Spain
1182.48.3405 Boehringer Ingelheim Investigational Site
Badalona, Spain
1182.48.3407 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.48.3408 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.48.3401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.48.3409 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1182.48.3406 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
1182.48.3410 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3403 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3404 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3411 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3412 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3402 Boehringer Ingelheim Investigational Site
Madrid, Spain
1182.48.3417 Boehringer Ingelheim Investigational Site
Malaga, Spain
1182.48.3416 Boehringer Ingelheim Investigational Site
San Sebastian, Spain
1182.48.3413 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1182.48.3420 Boehringer Ingelheim Investigational Site
Valencia, Spain
1182.48.3414 Boehringer Ingelheim Investigational Site
Valencia, Spain
1182.48.3418 Boehringer Ingelheim Investigational Site
Vigo, Spain
Sweden
1182.48.4603 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1182.48.4602 Boehringer Ingelheim Investigational Site
Malmö, Sweden
1182.48.4601 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Switzerland
1182.48.4101 Universitätsspital Basel
Basel, Switzerland
1182.48.4104 Hopital Universitaire de Genève
Genève, Switzerland
1182.48.4103 Kantonsspital St. Gallen
St. Gallen, Switzerland
1182.48.4102 Universitätsspital Zürich
Zürich, Switzerland
United Kingdom
1182.48.4405 Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
1182.48.4412 Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
1182.48.4411 Boehringer Ingelheim Investigational Site
Liverpool, United Kingdom
1182.48.4418 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4414 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4406 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4409 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4408 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.48.4417 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1182.48.4407 Boehringer Ingelheim Investigational Site
Portsmouth, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144170     History of Changes
Other Study ID Numbers: 1182.48, RESIST 2
Study First Received: September 2, 2005
Results First Received: September 11, 2009
Last Updated: June 23, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Bundesministerium fuer soziale Sicherheit und Generationen
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Tipranavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014