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

June 23, 2014 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

882

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tipranavir(TPV)/low dose ritonavir(r)
Other: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response at Week 48
Time Frame: after 48 weeks of treatment
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
after 48 weeks of treatment
Time to Treatment Failure Through 48 Weeks of Treatment
Time Frame: after 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.
after 48 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response at Week 2
Time Frame: 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
week 2
Treatment Response at Week 4
Time Frame: 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
week 4
Treatment Response at Week 8
Time Frame: 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
week 8
Treatment Response at Week 16
Time Frame: 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
week 16
Treatment Response at Week 24
Time Frame: 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
Week 24
Treatment Response at Week 32
Time Frame: 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
week 32
Treatment Response at Week 40
Time Frame: 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
week 40
Treatment Response at Week 56
Time Frame: 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
week 56
Treatment Response at Week 64
Time Frame: 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
week 64
Treatment Response at Week 72
Time Frame: 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
week 72
Treatment Response at Week 80
Time Frame: 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
week 80
Treatment Response at Week 88
Time Frame: 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
week 88
Treatment Response at Week 96
Time Frame: after 96 weeks of treatment
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
after 96 weeks of treatment
Time to Treatment Failure Through 96 Weeks of Treatment
Time Frame: after 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.
after 96 weeks of treatment
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time Frame: after 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.
after 48 weeks of treatment
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time Frame: after 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.
after 96 weeks of treatment
Virologic Response
Time Frame: Week 2 through Week 96 (at any point during trial)
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Time Frame: Week 2
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 2
Virologic Response at Week 4
Time Frame: week 4
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 4
Virologic Response at Week 8
Time Frame: week 8
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 8
Virologic Response at Week 16
Time Frame: week 16
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 16
Virologic Response at Week 24
Time Frame: week 24
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 24
Virologic Response at Week 32
Time Frame: week 32
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 32
Virologic Response at Week 40
Time Frame: week 40
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 40
Virologic Response at Week 48
Time Frame: week 48
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 48
Virologic Response at Week 56
Time Frame: week 56
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 56
Virologic Response at Week 64
Time Frame: week 64
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
week 64
Virologic Response at Week 72
Time Frame: Week 72
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 72
Virologic Response at Week 80
Time Frame: Week 80
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 80
Virologic Response at Week 88
Time Frame: Week 88
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 88
Virologic Response at Week 96
Time Frame: Week 96
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Week 96
Median Change From Baseline in Viral Load (Week 2)
Time Frame: Baseline to Week 2
Baseline to Week 2
Median Change From Baseline in Viral Load (Week 4)
Time Frame: Baseline to Week 4
Baseline to Week 4
Median Change From Baseline in Viral Load (Week 8)
Time Frame: Baseline to Week 8
Baseline to Week 8
Median Change From Baseline in Viral Load (Week 16)
Time Frame: Baseline to Week 16
Baseline to Week 16
Median Change From Baseline in Viral Load (Week 24)
Time Frame: Baseline to Week 24
Baseline to Week 24
Median Change From Baseline in Viral Load (Week 32)
Time Frame: Baseline to Week 32
Baseline to Week 32
Median Change From Baseline in Viral Load (Week 40)
Time Frame: Baseline to Week 40
Baseline to Week 40
Median Change From Baseline in Viral Load (Week 48)
Time Frame: Baseline to Week 48
Baseline to Week 48
Median Change From Baseline in Viral Load (Week 56)
Time Frame: Baseline to Week 56
Baseline to Week 56
Median Change From Baseline in Viral Load (Week 64)
Time Frame: Baseline to Week 64
Baseline to Week 64
Median Change From Baseline in Viral Load (Week 72)
Time Frame: Baseline to Week 72
Baseline to Week 72
Median Change From Baseline in Viral Load (Week 80)
Time Frame: Baseline to Week 80
Baseline to Week 80
Median Change From Baseline in Viral Load (Week 88)
Time Frame: Baseline to Week 88
Baseline to Week 88
Median Change From Baseline in Viral Load (Week 96)
Time Frame: Baseline to Week 96
Baseline to Week 96
Virologic Response at Week 40
Time Frame: Week 40
Virologic response defined as Viral Load<400 copies/mL
Week 40
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Time Frame: Week 2 through Week 96 (at any point during trial)
Virologic response defined as Viral Load<400 copies/mL
Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Time Frame: Week 2
Virologic response defined as Viral Load<400 copies/mL
Week 2
Virologic Response at Week 4
Time Frame: Week 4
Virologic response defined as Viral Load<400 copies/mL
Week 4
Virologic Response at Week 8
Time Frame: Week 8
Virologic response defined as Viral Load<400 copies/mL
Week 8
Virologic Response at Week 16
Time Frame: Week 16
Virologic response defined as Viral Load<400 copies/mL
Week 16
Virologic Response at Week 24
Time Frame: Week 24
Virologic response defined as Viral Load<400 copies/mL
Week 24
Virologic Response at Week 32
Time Frame: Week 32
Virologic response defined as Viral Load<400 copies/mL
Week 32
Virologic Response at Week 48
Time Frame: Week 48
Virologic response defined as Viral Load<400 copies/mL
Week 48
Virologic Response at Week 56
Time Frame: Week 56
Virologic response defined as Viral Load<400 copies/mL
Week 56
Virologic Response at Week 64
Time Frame: Week 64
Virologic response defined as Viral Load<400 copies/mL
Week 64
Virologic Response at Week 72
Time Frame: Week 72
Virologic response defined as Viral Load<400 copies/mL
Week 72
Virologic Response at Week 80
Time Frame: Week 80
Virologic response defined as Viral Load<400 copies/mL
Week 80
Virologic Response at Week 88
Time Frame: week 88
Virologic response defined as Viral Load<400 copies/mL
week 88
Virologic Response at Week 96
Time Frame: week 96
Virologic response defined as Viral Load<400 copies/mL
week 96
Virologic Response
Time Frame: Week 2 through Week 96 (at any point during trial)
Virologic response defined as Viral Load<50 copies/mL
Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Time Frame: Week 2
Virologic response defined as Viral Load<50 copies/mL
Week 2
Virologic Response at Week 4
Time Frame: Week 4
Virologic response defined as Viral Load<50 copies/mL
Week 4
Virologic Response at Week 8
Time Frame: Week 8
Virologic response defined as Viral Load<50 copies/mL
Week 8
Virologic Response at Week 16
Time Frame: Week 16
Virologic response defined as Viral Load<50 copies/mL
Week 16
Virologic Response at Week 24
Time Frame: Week 24
Viral Load < 50 copies/mL
Week 24
Virologic Response at Week 32
Time Frame: Week 32
Virologic response defined as Viral Load<50 copies/mL
Week 32
Virologic Response at Week 40
Time Frame: Week 40
Virologic response defined as Viral Load<50 copies/mL
Week 40
Virologic Response at Week 48
Time Frame: Week 48
Virologic response defined as Viral Load<50 copies/mL
Week 48
Virologic Response at Week 56
Time Frame: Week 56
Virologic response defined as Viral Load<50 copies/mL
Week 56
Virologic Response at Week 64
Time Frame: Week 64
Virologic response defined as Viral Load<50 copies/mL
Week 64
Virologic Response at Week 72
Time Frame: Week 72
Virologic response defined as Viral Load<50 copies/mL
Week 72
Virologic Response at Week 80
Time Frame: Week 80
Virologic response defined as Viral Load<50 copies/mL
Week 80
Virologic Response at Week 88
Time Frame: Week 88
Virologic response defined as Viral Load<50 copies/mL
Week 88
Virologic Response at Week 96
Time Frame: Week 96
Virologic response defined as Viral Load<50 copies/mL
Week 96
Mean Change From Baseline in CD4+ Cell Count (Week 2)
Time Frame: Baseline to Week 2
Baseline to Week 2
Mean Change From Baseline in CD4+ Cell Count (Week 4)
Time Frame: Baseline to Week 4
Baseline to Week 4
Mean Change From Baseline in CD4+ Cell Count (Week 8)
Time Frame: Baseline to Week 8
Baseline to Week 8
Mean Change From Baseline in CD4+ Cell Count (Week 16)
Time Frame: Baseline to Week 16
Baseline to Week 16
Mean Change From Baseline in CD4+ Cell Count (Week 24)
Time Frame: Baseline to Week 24
Baseline to Week 24
Mean Change From Baseline in CD4+ Cell Count (Week 32)
Time Frame: Baseline to Week 32
Baseline to Week 32
Mean Change From Baseline in CD4+ Cell Count (Week 40)
Time Frame: Baseline to Week 40
Baseline to Week 40
Mean Change From Baseline in CD4+ Cell Count (Week 48)
Time Frame: Baseline to Week 48
Baseline to Week 48
Mean Change From Baseline in CD4+ Cell Count (Week 56)
Time Frame: Baseline to Week 56
Baseline to Week 56
Mean Change From Baseline in CD4+ Cell Count (Week 64)
Time Frame: Baseline to Week 64
Baseline to Week 64
Mean Change From Baseline in CD4+ Cell Count (Week 72)
Time Frame: Baseline to Week 72
Baseline to Week 72
Mean Change From Baseline in CD4+ Cell Count (Week 80)
Time Frame: Baseline to Week 80
Baseline to Week 80
Mean Change From Baseline in CD4+ Cell Count (Week 88)
Time Frame: Baseline to Week 88
Baseline to Week 88
Mean Change From Baseline in CD4+ Cell Count (Week 96)
Time Frame: Baseline to Week 96
Baseline to Week 96
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Time Frame: up to 75 weeks of treatment

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.

up to 75 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Tipranavir (with low dose ritonavir)

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