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

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 visits.
  3. Male and female subjects 18 years and 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 principal 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 (<Common Toxicity Criteria (CTC) Grade 2).
    • Total Triglycerides ≤750 mg/dl (<Division of AIDS (DAIDS) Grade 2).
    • Alanine aminotransferase (ALT) ≤3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) ≤2.5x ULN (<DAIDS Grade 1).
    • 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 requirements 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 values.
  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
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

  Hide Study Locations
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
1182.17.47 University of Southern California
Los Angeles, California, United States
1182.17.106 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1182.17.40 Tower ID Medical
Los Angeles, California, United States
1182.17.73 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1182.17.46 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1182.17.15 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1182.17.128 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1182.17.114 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1182.17.37 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1182.17.96 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1182.17.58 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
1182.17.43 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1182.17.65 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1182.17.112 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
1182.17.22 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1182.17.131 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
1182.17.70 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1182.17.136 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
1182.17.63 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
1182.17.111 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
1182.17.6 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1182.17.115 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
1182.17.42 Beth Israel Medical Center
New York, New York, United States
1182.17.3 Division of Infectious Diseases
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
1182.17.105 Pollari Medical Group
New York, New York, United States
1182.17.130 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.17.135 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
1182.17.99 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1182.17.110 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
1182.17.16 Nelson-Tebedo Clinic
Dallas, Texas, United States
1182.17.142 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1182.17.116 Boehringer Ingelheim Investigational Site
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, New South Wales
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
1182.17.408 407 Doctors Pty Ltd.
Darlinghurst, New South Wales, Australia
1182.17.407 Holdsworth House General Practice
Darlinghurst, New South Wales, Australia
1182.17.403 Albion Street Clinic
Surry Hills, New South Wales, Australia
Australia, Victoria
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
1182.17.5504 Enfermaria de MI
São Paulo - SP, Brazil
1182.17.5503 Instituto de Infectologia Emílio Ribas
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, British Columbia
1182.17.902 Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada
Canada, Ontario
1182.17.913 McMaster University Medical Centre
Hamilton, Ontario, Canada
1182.17.901 Division of Infectious Diseases
Ottawa, Ontario, Canada
1182.17.910 Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada
1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario, Canada
1182.17.907 University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital
Toronto, Ontario, Canada
Canada, Quebec
1182.17.914 Montreal General Hospital - McGill University Health Centre
Monteal, Quebec, Canada
1182.17.915 Clinique medicale l'Actuel
Montreal, Quebec, Canada
1182.17.904 Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada
1182.17.903 Montreal Chest Institute, McGill University Health Centre
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
1182.17.33019 Hôpital Saint André
Bordeaux cedex, France
1182.17.33011 Hôpital Pellegrin
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
1182.17.00334 Hôpital de la Pitié Salpêtrière
Paris, France
1182.17.00333 Hôpital Saint Louis
Paris, France
1182.17.33014 Hôpital Saint Antoine
Paris, 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
1182.17.33018 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
1182.17.4902 Charite, Campus Virchow-Klinikum
Berlin, Germany
1182.17.4901 Epimed GmbH c/o
Berlin, Germany
1182.17.4918 Rheinische Friedrich-Wilhelm-Universität
Bonn, Germany
1182.17.4906 ID-Ambulanz Klinikum Dortmund
Dortmund, Germany
1182.17.4914 Arzt für Innere Medizin
Düsseldorf, Germany
1182.17.4912 Universitätsklinikum Düsseldorf
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
1182.17.4928 Facharzt für Innere Medizin/Rheumatologie
Freiburg, Germany
1182.17.4930 Universitätsklinikum Freiburg
Freiburg/Breisgau, 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
1182.17.4926 Internist
Köln, Germany
1182.17.4905 Universitätsklinik Köln
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
1182.17.3003 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.17.3001 Boehringer Ingelheim Investigational Site
Athens, Greece
1182.17.3002 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
1182.17.0412 S.C. Malattie Infettive
Genova, Italy
1182.17.0397 Ospedale San Martino
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
1182.17.0394 IRCCS Policlinico San Matteo
Pavia, Italy
1182.17.0385 IRCCS Policlinico San Matteo
Pavia, Italy
1182.17.0419 I Cattedra Malattie Infettive
Roma, Italy
1182.17.0395 Azienda Policlinico Umberto I
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
1182.17.704 Hospital Ramón y Cajal.
Madrid, Spain
1182.17.703 Hospital 12 de Octubre
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
1182.17.4408 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.17.4418 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.17.4406 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.17.4414 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.17.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.17.4409 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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00146328     History of Changes
Other Study ID Numbers: 1182.17
Study First Received: September 5, 2005
Results First Received: May 26, 2009
Last Updated: January 31, 2014
Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología)
Australia: Responsilble Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014