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Clinical Trials

MainTitle

Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects

This study has been completed
Sponsor
Boehringer Ingelheim


Information provided by (Responsible Party)
Boehringer Ingelheim
ClinicalTrials.gov Identifier
NCT00146328

First received: September 5, 2005
Last updated: January 31, 2014
Last Verified: January 2014
History of Changes
Purpose

Purpose

The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.

Condition Intervention Phase
HIV Infections

Drug : Tipranavir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures

  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct. [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT) [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT) [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL) [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
  • Number of Patients With Adverse Events Leading to Death [ Time Frame: End of Trial (>288 weeks) ]
    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Secondary Outcome Measures:
  • Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline to 192-240 week time interval ]
    Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)
  • Change From Baseline in CD4 Cell Count (LOCF) [ Time Frame: Baseline to 192-240 week time interval ]
    Change from baseline in CD4 cell count with last observation carried forward(LOCF).

Enrollment: 997
Study Start Date: April 2001
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Group 1
Patients With Varying Degrees of Tipranavir Treatment Experience
Drug: Tipranavir
Experimental: Group 2
Highly Tipranavir Treatment Experienced Patients
Drug: Tipranavir
Experimental: Group 3
Tipranavir Treatment Naive Patients
Drug: Tipranavir
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

INCLUSION CRITERIA

  1. Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
  2. All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or
  3. 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visi
  4. ts.

3. Male and female subjects 18 years a
  • nd over.

  • 4. Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to
  • study entry.

  • 5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by princi
  • pal investigator).

  • 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 ( Total Triglycerides ≤750 mg/dl ( Alanine aminotransferase (ALT) ≤3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) ≤2.5x ULN ( Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable.
    • Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
    • All other laboratory test values ≤DAIDS Grade 1.


  • EXCLUSION CRITERIA

  • 1. Female subjects who are of reproductive potential who:
    • Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit.
    • Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms).

  • - Are breast-feeding.

  • 2. Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to
  • health and to protocol adherence.

  • 3. Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requir
  • ements of this protocol.

  • 4. History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering
  • tipranavir/ritonavir to the subject.

  • 5. Active use of any of the following:
    • Investigational HIV-1 vaccines.
    • Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial.
    • Medications excluded during the trial period (see Section 4.2).

  • - Herbal medications (e.g., St. John's Wort).

  • 6. Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator.
    If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer
  • Ingelheim Clinical Monitor or Local Clinical Monitor.

  • 7. Clinically significant liver disease in the 90 days prior to baseline visit,
  • regardless of baseline AST and/or ALT value
  • s. 8. Hypersensitivity to tipranavir or ritonavir.

  • 9. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.

    contacts and locations

    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: NCT00146328

    Locations

    United States, Arizona
    1182.17.39 MDS Pharma Services
    Phoenix, Arizona, United States
    1182.17.75 Boehringer Ingelheim Investigational Site
    Phoenix, Arizona, United States
    United States, California
    1182.17.89 Boehringer Ingelheim Investigational Site
    Berkeley, California, United States
    1182.17.60 Boehringer Ingelheim Investigational Site
    Fountain Valley, California, United States
    1182.17.106 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
    1182.17.15 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
    1182.17.40 Tower ID Medical
    Los Angeles, California, United States
    1182.17.46 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
    1182.17.47 University of Southern California
    Los Angeles, California, United States
    1182.17.73 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
    1182.17.114 Boehringer Ingelheim Investigational Site
    San Diego, California, United States
    1182.17.128 Boehringer Ingelheim Investigational Site
    San Diego, California, United States
    1182.17.37 Boehringer Ingelheim Investigational Site
    San Francisco, California, United States
    1182.17.58 Boehringer Ingelheim Investigational Site
    San Francisco, California, United States
    1182.17.96 Boehringer Ingelheim Investigational Site
    San Francisco, California, United States
    United States, Connecticut
    1182.17.87 Boehringer Ingelheim Investigational Site
    Norwalk, Connecticut, United States
    United States, District of Columbia
    1182.17.112 Boehringer Ingelheim Investigational Site
    Washington, District of Columbia, United States
    1182.17.43 Boehringer Ingelheim Investigational Site
    Washington, District of Columbia, United States
    1182.17.65 Boehringer Ingelheim Investigational Site
    Washington, District of Columbia, United States
    United States, Florida
    1182.17.126 Boehringer Ingelheim Investigational Site
    Fort Lauderdale, Florida, United States
    1182.17.8 Boehringer Ingelheim Investigational Site
    Fort Myers, Florida, United States
    1182.17.131 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
    1182.17.22 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
    1182.17.64 Boehringer Ingelheim Investigational Site
    Orlando, Florida, United States
    1182.17.129 Boehringer Ingelheim Investigational Site
    Sarasota, Florida, United States
    1182.17.51 Boehringer Ingelheim Investigational Site
    South Miami, Florida, United States
    1182.17.125 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
    1182.17.132 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
    1182.17.76 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
    1182.17.52 Boehringer Ingelheim Investigational Site
    Vero Beach, Florida, United States
    United States, Georgia
    1182.17.77 Boehringer Ingelheim Investigational Site
    Atlanta, Georgia, United States
    1182.17.69 Boehringer Ingelheim Investigational Site
    Macon, Georgia, United States
    United States, Illinois
    1182.17.136 Boehringer Ingelheim Investigational Site
    Chicago, Illinois, United States
    1182.17.70 Boehringer Ingelheim Investigational Site
    Chicago, Illinois, United States
    1182.17.36 Boehringer Ingelheim Investigational Site
    Evanston, Illinois, United States
    United States, Indiana
    1182.17.1 Boehringer Ingelheim Investigational Site
    Indianapolis, Indiana, United States
    United States, Kansas
    1182.17.32 University of Kansas School of Medicine - Wichita
    Wichita, Kansas, United States
    United States, Kentucky
    1182.17.102 Boehringer Ingelheim Investigational Site
    Lexington, Kentucky, United States
    1182.17.21 Boehringer Ingelheim Investigational Site
    Louisville, Kentucky, United States
    United States, Maine
    1182.17.30 Boehringer Ingelheim Investigational Site
    Portland, Maine, United States
    United States, Maryland
    1182.17.67 Boehringer Ingelheim Investigational Site
    Baltimore, Maryland, United States
    1182.17.86 Boehringer Ingelheim Investigational Site
    Bethesda, Maryland, United States
    United States, Massachusetts
    1182.17.111 Boehringer Ingelheim Investigational Site
    Boston, Massachusetts, United States
    1182.17.63 Boehringer Ingelheim Investigational Site
    Boston, Massachusetts, United States
    1182.17.74 Boehringer Ingelheim Investigational Site
    Springfield, Massachusetts, United States
    United States, Michigan
    1182.17.4 Boehringer Ingelheim Investigational Site
    Ann Arbor, Michigan, United States
    1182.17.115 Boehringer Ingelheim Investigational Site
    Detroit, Michigan, United States
    1182.17.6 Boehringer Ingelheim Investigational Site
    Detroit, Michigan, United States
    United States, Missouri
    1182.17.62 Boehringer Ingelheim Investigational Site
    Kansas City, Missouri, United States
    United States, Nevada
    1182.17.59 Boehringer Ingelheim Investigational Site
    Las Vegas, Nevada, United States
    United States, New Jersey
    1182.17.118 Early Intervention Program (EIP) Clinic
    Camden, New Jersey, United States
    1182.17.93 Boehringer Ingelheim Investigational Site
    East Orange, New Jersey, United States
    1182.17.24 Hackensack University Medical Center
    Hackensack, New Jersey, United States
    1182.17.34 ID Care, Inc.
    Hillsborough, New Jersey, United States
    United States, New Mexico
    1182.17.50 Boehringer Ingelheim Investigational Site
    Santa Fe, New Mexico, United States
    United States, New York
    1182.17.79 Boehringer Ingelheim Investigational Site
    Albany, New York, United States
    1182.17.103 Boehringer Ingelheim Investigational Site
    Mount Vernon, New York, United States
    1182.17.105 Pollari Medical Group
    New York, New York, United States
    1182.17.130 Boehringer Ingelheim Investigational Site
    New York, New York, United States
    1182.17.3 Division of Infectious Diseases
    New York, New York, United States
    1182.17.42 Beth Israel Medical Center
    New York, New York, United States
    1182.17.5 Boehringer Ingelheim Investigational Site
    New York, New York, United States
    1182.17.7 Boehringer Ingelheim Investigational Site
    New York, New York, United States
    1182.17.94 Boehringer Ingelheim Investigational Site
    New York, New York, United States
    1182.17.135 Boehringer Ingelheim Investigational Site
    Rochester, New York, United States
    1182.17.31 Boehringer Ingelheim Investigational Site
    Stony Brook, New York, United States
    United States, North Carolina
    1182.17.53 Boehringer Ingelheim Investigational Site
    Durham, North Carolina, United States
    1182.17.54 Boehringer Ingelheim Investigational Site
    Huntersville, North Carolina, United States
    United States, Ohio
    1182.17.134 Summa Health System
    Akron, Ohio, United States
    1182.17.95 Boehringer Ingelheim Investigational Site
    Cincinnati, Ohio, United States
    1182.17.26 Boehringer Ingelheim Investigational Site
    Columbus, Ohio, United States
    United States, Oklahoma
    1182.17.9 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
    United States, Pennsylvania
    1182.17.110 Boehringer Ingelheim Investigational Site
    Philadelphia, Pennsylvania, United States
    1182.17.99 Boehringer Ingelheim Investigational Site
    Philadelphia, Pennsylvania, United States
    United States, South Carolina
    1182.17.23 Boehringer Ingelheim Investigational Site
    Columbia, South Carolina, United States
    United States, Tennessee
    1182.17.11 Boehringer Ingelheim Investigational Site
    Memphis, Tennessee, United States
    1182.17.18 Vanderbilt AIDS Clinical Trials Center
    Nashville, Tennessee, United States
    United States, Texas
    1182.17.116 Boehringer Ingelheim Investigational Site
    Dallas, Texas, United States
    1182.17.142 Boehringer Ingelheim Investigational Site
    Dallas, Texas, United States
    1182.17.16 Nelson-Tebedo Clinic
    Dallas, Texas, United States
    1182.17.122 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
    1182.17.68 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
    1182.17.97 Boehringer Ingelheim Investigational Site
    San Antonio, Texas, United States
    United States, Virginia
    1182.17.10 Boehringer Ingelheim Investigational Site
    Annandale, Virginia, United States
    United States, Washington
    1182.17.92 Boehringer Ingelheim Investigational Site
    Tacoma, Washington, United States
    United States, Wisconsin
    1182.17.100 Boehringer Ingelheim Investigational Site
    Milwaukee, Wisconsin, United States
    Argentina
    1182.17.5401 Fundacion Huesped
    Capital Federal, Argentina
    1182.17.5402 Funcei
    Capital Federal, Argentina
    1182.17.5403 consultorio externo "PETS"
    Capital Federal, Argentina
    1182.17.5404 Infectología
    Capital Federal, Argentina
    1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)
    Capital Federal, Argentina
    1182.17.5406 Pabellón de Clínicas 2° Piso
    Capital Federal, Argentina
    Australia
    1182.17.401 St. Vincent's Hospital
    Darlinghurst, New South Wales, Australia
    1182.17.402 Taylor Square Private Clinic
    Darlinghurst, New South Wales, Australia
    1182.17.405 AIDS Research Initiative
    DarlingHurst, New South Wales, Australia
    1182.17.407 Holdsworth House General Practice
    Darlinghurst, New South Wales, Australia
    1182.17.408 407 Doctors Pty Ltd.
    Darlinghurst, New South Wales, Australia
    1182.17.403 Albion Street Clinic
    Surry Hills, New South Wales, Australia
    1182.17.404 Alfred Hospital
    Melbourne, Victoria, Australia
    Austria
    1182.17.4301 Boehringer Ingelheim Investigational Site
    Wien, Austria
    Belgium
    1182.17.3209 Instituut Tropische Geneeskunde
    Antwerpen, Belgium
    1182.17.3201 Boehringer Ingelheim Investigational Site
    Bruxelles, Belgium
    1182.17.3202 Boehringer Ingelheim Investigational Site
    Bruxelles, Belgium
    1182.17.3207 Boehringer Ingelheim Investigational Site
    Gent, Belgium
    1182.17.3210 Centre Hospitalier de Luxembourg
    Luxembourg, Belgium
    Brazil
    1182.17.5511 Universidade Federal da Bahia
    Canela - Salvador - BA, Brazil
    1182.17.5508 I.I. Emilio Ribas
    Cerqueira César, São Paulo - SP, Brazil
    1182.17.5509 (Unidade de Testes Terapêuticos)
    Cidade Nova - Rio de Janeiro - RJ, Brazil
    1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas
    Manguinhos - Rio de Janeiro - RJ, Brazil
    1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC
    Mercês - Curitiba - PR, Brazil
    1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
    Nova Iguaçu - Rio de Janeiro - RJ, Brazil
    1182.17.5501 Hospital Dia
    Sacoma - São Paulo - SP, Brazil
    1182.17.5503 Instituto de Infectologia Emílio Ribas
    São Paulo - SP, Brazil
    1182.17.5504 Enfermaria de MI
    São Paulo - SP, Brazil
    1182.17.5510 Casa de AIDS
    São Paulo, SP, Brazil
    1182.17.5506 Centro de Referência e Treinamento - DST/AIDS
    Vila Mariana, Sao Paulo - SP, Brazil
    Canada
    1182.17.902 Downtown Infectious Diseases Clinic
    Vancouver, British Columbia, Canada
    1182.17.913 McMaster University Medical Centre
    Hamilton, Ontario, Canada
    1182.17.901 Division of Infectious Diseases
    Ottawa, Ontario, Canada
    1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.
    Toronto, Ontario, Canada
    1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital
    Toronto, Ontario, Canada
    1182.17.907 University Health Network - Toronto General Hospital
    Toronto, Ontario, Canada
    1182.17.910 Sunnybrook & Women's College Health Science Centre
    Toronto, Ontario, Canada
    1182.17.914 Montreal General Hospital - McGill University Health Centre
    Monteal, Quebec, Canada
    1182.17.903 Montreal Chest Institute, McGill University Health Centre
    Montreal, Quebec, Canada
    1182.17.904 Clinique Medicale Du Quartier Latin
    Montreal, Quebec, Canada
    1182.17.915 Clinique medicale l'Actuel
    Montreal, Quebec, Canada
    Denmark
    1182.17.4505 Boehringer Ingelheim Investigational Site
    Aarhus N, Denmark
    1182.17.4501 Boehringer Ingelheim Investigational Site
    Copenhagen Ø, Denmark
    1182.17.4502 Boehringer Ingelheim Investigational Site
    Hvidovre, Denmark
    1182.17.4504 Boehringer Ingelheim Investigational Site
    Odense, Denmark
    France
    1182.17.33011 Hôpital Pellegrin
    Bordeaux cedex, France
    1182.17.33019 Hôpital Saint André
    Bordeaux cedex, France
    1182.17.33020 Hôpital Côte de Nacre
    Caen cedex 5, France
    1182.17.33007 Hôpital Antoine Beclere
    Clamart, France
    1182.17.33008 Hôpital de l'Hôtel Dieu
    Lyon cedex 2, France
    1182.17.33023 Hôpital Edouard Herriot
    Lyon cedex 3, France
    1182.17.33012 Hôpital de la Conception
    Marseille cedex 5, France
    1182.17.33013 Hôpital Sainte Marguerite
    Marseille cedex 9, France
    1182.17.00336 Hôpital Hôtel Dieu
    Nantes cedex 1, France
    1182.17.33010 Hôpital de l'Archet
    Nice cedex 3, France
    1182.17.33024 Groupe Hospitalier Cochin
    Paris cedex 14, France
    1182.17.33022 Hôpital Européen Georges Pompidou
    Paris cedex 15, France
    1182.17.00335 Hôpital Bichat Claude Bernard
    Paris cedex 18, France
    1182.17.00331 Hôpital Tenon
    Paris cedex 20, France
    1182.17.00333 Hôpital Saint Louis
    Paris, France
    1182.17.00334 Hôpital de la Pitié Salpêtrière
    Paris, France
    1182.17.33014 Hôpital Saint Antoine
    Paris, France
    1182.17.33018 Hôpital de Pontchaillou
    Rennes cedex 9, France
    1182.17.33016 Hôpital Civil
    Strasbourg cedex, France
    1182.17.00332 Hôpital du Chalucet
    Toulon, France
    1182.17.33017 Hôpital Brabois Adultes
    Vandoeuvre les Nancy, France
    1182.17.33021 Hôpital Paul Brousse
    Villejuif cedex, France
    Germany
    1182.17.4911 Arzt für Innere Medizin
    Aachen, Germany
    1182.17.4901 Epimed GmbH c/o
    Berlin, Germany
    1182.17.4902 Charite, Campus Virchow-Klinikum
    Berlin, Germany
    1182.17.4918 Rheinische Friedrich-Wilhelm-Universität
    Bonn, Germany
    1182.17.4906 ID-Ambulanz Klinikum Dortmund
    Dortmund, Germany
    1182.17.4912 Universitätsklinikum Düsseldorf
    Düsseldorf, Germany
    1182.17.4914 Arzt für Innere Medizin
    Düsseldorf, Germany
    1182.17.4908 Universitätskliniken Erlangen
    Erlangen, Germany
    1182.17.4904 Universitätsklinikum Essen
    Essen, Germany
    1182.17.4924 Klinikum der J. W.-Goethe-Universität
    Frankfurt/Main, Germany
    1182.17.4930 Universitätsklinikum Freiburg
    Freiburg/Breisgau, Germany
    1182.17.4928 Facharzt für Innere Medizin/Rheumatologie
    Freiburg, Germany
    1182.17.4916 Medizinisches Versorgungszentrum Hamburg
    Hamburg, Germany
    1182.17.4929 Universitätsklinikum Eppendorf
    Hamburg, Germany
    1182.17.4931 IPM Study Center GmbH
    Hamburg, Germany
    1182.17.4920 Abteilung Klinische Immunologie
    Hannover, Germany
    1182.17.4909 Universitätsklinikum Heidelberg
    Heidelberg, Germany
    1182.17.4905 Universitätsklinik Köln
    Köln, Germany
    1182.17.4926 Internist
    Köln, Germany
    1182.17.4923 Facharzt für Innere Medizin,
    Mannheim, Germany
    1182.17.4907 Medizinische Poliklinik
    München, Germany
    1182.17.4910 MUC Research GmbH
    München, Germany
    1182.17.4915 Klinium Natruper Holz
    Osnabrück, Germany
    1182.17.4921 Arzt für Allgemeinmedizin
    Stuttgart, Germany
    Greece
    1182.17.3001 Boehringer Ingelheim Investigational Site
    Athens, Greece
    1182.17.3002 Boehringer Ingelheim Investigational Site
    Athens, Greece
    1182.17.3003 Boehringer Ingelheim Investigational Site
    Athens, Greece
    1182.17.3004 Boehringer Ingelheim Investigational Site
    Athens, Greece
    1182.17.3007 Boehringer Ingelheim Investigational Site
    Athens, Greece
    1182.17.3010 Boehringer Ingelheim Investigational Site
    Patras, Greece
    1182.17.3009 Boehringer Ingelheim Investigational Site
    Thessaloniki, Greece
    Italy
    1182.17.0409 Ospedale Santa Maria Annunziata
    Antella (fi), Italy
    1182.17.0413 Ospedale di Circolo di Busto
    Busto Arsizio (va), Italy
    1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna
    Ferrara, Italy
    1182.17.0397 Ospedale San Martino
    Genova, Italy
    1182.17.0412 S.C. Malattie Infettive
    Genova, Italy
    1182.17.0411 Presidio Ospedaliero "A. Manzoni"
    Lecco, Italy
    1182.17.0389 Reparto Malattie Infettive
    Macerata, Italy
    1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor
    Milano, Italy
    1182.17.0386 Policlinico Universitario
    Modena, Italy
    1182.17.0388 Ospedale A. Cotugno
    Napoli, Italy
    1182.17.0385 IRCCS Policlinico San Matteo
    Pavia, Italy
    1182.17.0394 IRCCS Policlinico San Matteo
    Pavia, Italy
    1182.17.0395 Azienda Policlinico Umberto I
    Roma, Italy
    1182.17.0419 I Cattedra Malattie Infettive
    Roma, Italy
    1182.17.0387 Ospedale Amedeo di Savoia
    Torino, Italy
    1182.17.0398 Ospedale Amedeo di Savoia
    Torino, Italy
    1182.17.0415 U.O.A. Malattie Infettive B
    Torino, Italy
    Mexico
    1182.17.5201 Centro Médico La Raza IMSS
    Col. La Raza, Mexico, Mexico
    1182.17.5203 Hospital Civil Nuevo de Guadalajara
    Guadalajara, Mexico
    1182.17.5206 Centro Medico San Vicente
    Monterrey, N.l., Mexico, Mexico
    Netherlands
    1182.17.3101 Boehringer Ingelheim Investigational Site
    Amsterdam, Netherlands
    1182.17.3108 Boehringer Ingelheim Investigational Site
    Groningen, Netherlands
    1182.17.3105 Boehringer Ingelheim Investigational Site
    Nijmegen, Netherlands
    1182.17.202 Boehringer Ingelheim Investigational Site
    Rotterdam, Netherlands
    Portugal
    1182.17.3502 Hospital Condes Castro Guimarães
    Cascais, Portugal
    Spain
    1182.17.705 Hospital Germans Trias i Pujol
    Badalona, Spain
    1182.17.701 Hospital Clínico y Provincial de Barcelona
    Barcelona, Spain
    1182.17.703 Hospital 12 de Octubre
    Madrid, Spain
    1182.17.704 Hospital Ramón y Cajal.
    Madrid, Spain
    1182.17.710 Hospital Gregorio Maranon
    Madrid, Spain
    1182.17.712 Hospital Clínico San Carlos
    Madrid, Spain
    1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria
    Malaga, Spain
    1182.17.713 Hospital Universitario Vírgen del Rocío
    Sevilla, Spain
    1182.17.714 Hospital General Universitario de Valencia
    Valencia, Spain
    1182.17.720 Hospital La Fe
    Valencia, Spain
    1182.17.718 Complejo Hospitalario Xeral - Cíes
    Vigo, Spain
    Switzerland
    1182.17.4101 DIM / Abteilung für Infektiologie
    Basel, Switzerland
    1182.17.4104 Département de médicine interne Div. Des maladies infectieus
    Genève, Switzerland
    1182.17.4103 DIM / Abteilung für Infektiologie
    St. Gallen, Switzerland
    1182.17.4102 Departement für Innere Medizin
    Zürich, Switzerland
    United Kingdom
    1182.17.4405 Boehringer Ingelheim Investigational Site
    Brighton, United Kingdom
    1182.17.4411 Boehringer Ingelheim Investigational Site
    Liverpool, United Kingdom
    1182.17.4404 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4406 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4408 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4409 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4414 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4418 Boehringer Ingelheim Investigational Site
    London, United Kingdom
    1182.17.4407
    Portsmouth, United Kingdom

    Sponsors and Collaborators

    Boehringer Ingelheim

    Investigators

    Study Chair: Boehringer Ingelheim Boehringer Ingelheim
    More Information

    More Information


    Responsible Party: Boehringer Ingelheim  
    ClinicalTrials.gov Identifier: NCT00146328   History of Changes  
    Other Study ID Numbers: 1182.17  
    Study First Received: September 5, 2005  
    Last Updated: January 31, 2014  

    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Tipranavir

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.