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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tipranavir
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

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

INCLUSION CRITERIA 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. 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. Male and female subjects 18 years and over. 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. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator). 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 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. 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. 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. 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. 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). 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. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values. Hypersensitivity to tipranavir or ritonavir. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.

Sites / Locations

  • 1182.17.39 MDS Pharma Services
  • 1182.17.75 Boehringer Ingelheim Investigational Site
  • 1182.17.89 Boehringer Ingelheim Investigational Site
  • 1182.17.60 Boehringer Ingelheim Investigational Site
  • 1182.17.106 Boehringer Ingelheim Investigational Site
  • 1182.17.15 Boehringer Ingelheim Investigational Site
  • 1182.17.40 Tower ID Medical
  • 1182.17.46 Boehringer Ingelheim Investigational Site
  • 1182.17.47 University of Southern California
  • 1182.17.73 Boehringer Ingelheim Investigational Site
  • 1182.17.114 Boehringer Ingelheim Investigational Site
  • 1182.17.128 Boehringer Ingelheim Investigational Site
  • 1182.17.37 Boehringer Ingelheim Investigational Site
  • 1182.17.58 Boehringer Ingelheim Investigational Site
  • 1182.17.96 Boehringer Ingelheim Investigational Site
  • 1182.17.87 Boehringer Ingelheim Investigational Site
  • 1182.17.112 Boehringer Ingelheim Investigational Site
  • 1182.17.43 Boehringer Ingelheim Investigational Site
  • 1182.17.65 Boehringer Ingelheim Investigational Site
  • 1182.17.126 Boehringer Ingelheim Investigational Site
  • 1182.17.8 Boehringer Ingelheim Investigational Site
  • 1182.17.131 Boehringer Ingelheim Investigational Site
  • 1182.17.22 Boehringer Ingelheim Investigational Site
  • 1182.17.64 Boehringer Ingelheim Investigational Site
  • 1182.17.129 Boehringer Ingelheim Investigational Site
  • 1182.17.51 Boehringer Ingelheim Investigational Site
  • 1182.17.125 Boehringer Ingelheim Investigational Site
  • 1182.17.132 Boehringer Ingelheim Investigational Site
  • 1182.17.76 Boehringer Ingelheim Investigational Site
  • 1182.17.52 Boehringer Ingelheim Investigational Site
  • 1182.17.77 Boehringer Ingelheim Investigational Site
  • 1182.17.69 Boehringer Ingelheim Investigational Site
  • 1182.17.136 Boehringer Ingelheim Investigational Site
  • 1182.17.70 Boehringer Ingelheim Investigational Site
  • 1182.17.36 Boehringer Ingelheim Investigational Site
  • 1182.17.1 Boehringer Ingelheim Investigational Site
  • 1182.17.32 University of Kansas School of Medicine - Wichita
  • 1182.17.102 Boehringer Ingelheim Investigational Site
  • 1182.17.21 Boehringer Ingelheim Investigational Site
  • 1182.17.30 Boehringer Ingelheim Investigational Site
  • 1182.17.67 Boehringer Ingelheim Investigational Site
  • 1182.17.86 Boehringer Ingelheim Investigational Site
  • 1182.17.111 Boehringer Ingelheim Investigational Site
  • 1182.17.63 Boehringer Ingelheim Investigational Site
  • 1182.17.74 Boehringer Ingelheim Investigational Site
  • 1182.17.4 Boehringer Ingelheim Investigational Site
  • 1182.17.115 Boehringer Ingelheim Investigational Site
  • 1182.17.6 Boehringer Ingelheim Investigational Site
  • 1182.17.62 Boehringer Ingelheim Investigational Site
  • 1182.17.59 Boehringer Ingelheim Investigational Site
  • 1182.17.118 Early Intervention Program (EIP) Clinic
  • 1182.17.93 Boehringer Ingelheim Investigational Site
  • 1182.17.24 Hackensack University Medical Center
  • 1182.17.34 ID Care, Inc.
  • 1182.17.50 Boehringer Ingelheim Investigational Site
  • 1182.17.79 Boehringer Ingelheim Investigational Site
  • 1182.17.103 Boehringer Ingelheim Investigational Site
  • 1182.17.105 Pollari Medical Group
  • 1182.17.130 Boehringer Ingelheim Investigational Site
  • 1182.17.3 Division of Infectious Diseases
  • 1182.17.42 Beth Israel Medical Center
  • 1182.17.5 Boehringer Ingelheim Investigational Site
  • 1182.17.7 Boehringer Ingelheim Investigational Site
  • 1182.17.94 Boehringer Ingelheim Investigational Site
  • 1182.17.135 Boehringer Ingelheim Investigational Site
  • 1182.17.31 Boehringer Ingelheim Investigational Site
  • 1182.17.53 Boehringer Ingelheim Investigational Site
  • 1182.17.54 Boehringer Ingelheim Investigational Site
  • 1182.17.134 Summa Health System
  • 1182.17.95 Boehringer Ingelheim Investigational Site
  • 1182.17.26 Boehringer Ingelheim Investigational Site
  • 1182.17.9 Boehringer Ingelheim Investigational Site
  • 1182.17.110 Boehringer Ingelheim Investigational Site
  • 1182.17.99 Boehringer Ingelheim Investigational Site
  • 1182.17.23 Boehringer Ingelheim Investigational Site
  • 1182.17.11 Boehringer Ingelheim Investigational Site
  • 1182.17.18 Vanderbilt AIDS Clinical Trials Center
  • 1182.17.116 Boehringer Ingelheim Investigational Site
  • 1182.17.142 Boehringer Ingelheim Investigational Site
  • 1182.17.16 Nelson-Tebedo Clinic
  • 1182.17.122 Boehringer Ingelheim Investigational Site
  • 1182.17.68 Boehringer Ingelheim Investigational Site
  • 1182.17.97 Boehringer Ingelheim Investigational Site
  • 1182.17.10 Boehringer Ingelheim Investigational Site
  • 1182.17.92 Boehringer Ingelheim Investigational Site
  • 1182.17.100 Boehringer Ingelheim Investigational Site
  • 1182.17.5401 Fundacion Huesped
  • 1182.17.5402 Funcei
  • 1182.17.5403 consultorio externo "PETS"
  • 1182.17.5404 Infectología
  • 1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)
  • 1182.17.5406 Pabellón de Clínicas 2° Piso
  • 1182.17.401 St. Vincent's Hospital
  • 1182.17.402 Taylor Square Private Clinic
  • 1182.17.405 AIDS Research Initiative
  • 1182.17.407 Holdsworth House General Practice
  • 1182.17.408 407 Doctors Pty Ltd.
  • 1182.17.403 Albion Street Clinic
  • 1182.17.404 Alfred Hospital
  • 1182.17.4301 Boehringer Ingelheim Investigational Site
  • 1182.17.3209 Instituut Tropische Geneeskunde
  • 1182.17.3201 Boehringer Ingelheim Investigational Site
  • 1182.17.3202 Boehringer Ingelheim Investigational Site
  • 1182.17.3207 Boehringer Ingelheim Investigational Site
  • 1182.17.3210 Centre Hospitalier de Luxembourg
  • 1182.17.5511 Universidade Federal da Bahia
  • 1182.17.5508 I.I. Emilio Ribas
  • 1182.17.5509 (Unidade de Testes Terapêuticos)
  • 1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas
  • 1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC
  • 1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
  • 1182.17.5501 Hospital Dia
  • 1182.17.5503 Instituto de Infectologia Emílio Ribas
  • 1182.17.5504 Enfermaria de MI
  • 1182.17.5510 Casa de AIDS
  • 1182.17.5506 Centro de Referência e Treinamento - DST/AIDS
  • 1182.17.902 Downtown Infectious Diseases Clinic
  • 1182.17.913 McMaster University Medical Centre
  • 1182.17.901 Division of Infectious Diseases
  • 1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.
  • 1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital
  • 1182.17.907 University Health Network - Toronto General Hospital
  • 1182.17.910 Sunnybrook & Women's College Health Science Centre
  • 1182.17.914 Montreal General Hospital - McGill University Health Centre
  • 1182.17.903 Montreal Chest Institute, McGill University Health Centre
  • 1182.17.904 Clinique Medicale Du Quartier Latin
  • 1182.17.915 Clinique medicale l'Actuel
  • 1182.17.4505 Boehringer Ingelheim Investigational Site
  • 1182.17.4501 Boehringer Ingelheim Investigational Site
  • 1182.17.4502 Boehringer Ingelheim Investigational Site
  • 1182.17.4504 Boehringer Ingelheim Investigational Site
  • 1182.17.33011 Hôpital Pellegrin
  • 1182.17.33019 Hôpital Saint André
  • 1182.17.33020 Hôpital Côte de Nacre
  • 1182.17.33007 Hôpital Antoine Beclere
  • 1182.17.33008 Hôpital de l'Hôtel Dieu
  • 1182.17.33023 Hôpital Edouard Herriot
  • 1182.17.33012 Hôpital de la Conception
  • 1182.17.33013 Hôpital Sainte Marguerite
  • 1182.17.00336 Hôpital Hôtel Dieu
  • 1182.17.33010 Hôpital de l'Archet
  • 1182.17.33024 Groupe Hospitalier Cochin
  • 1182.17.33022 Hôpital Européen Georges Pompidou
  • 1182.17.00335 Hôpital Bichat Claude Bernard
  • 1182.17.00331 Hôpital Tenon
  • 1182.17.00333 Hôpital Saint Louis
  • 1182.17.00334 Hôpital de la Pitié Salpêtrière
  • 1182.17.33014 Hôpital Saint Antoine
  • 1182.17.33018 Hôpital de Pontchaillou
  • 1182.17.33016 Hôpital Civil
  • 1182.17.00332 Hôpital du Chalucet
  • 1182.17.33017 Hôpital Brabois Adultes
  • 1182.17.33021 Hôpital Paul Brousse
  • 1182.17.4911 Arzt für Innere Medizin
  • 1182.17.4901 Epimed GmbH c/o
  • 1182.17.4902 Charite, Campus Virchow-Klinikum
  • 1182.17.4918 Rheinische Friedrich-Wilhelm-Universität
  • 1182.17.4906 ID-Ambulanz Klinikum Dortmund
  • 1182.17.4912 Universitätsklinikum Düsseldorf
  • 1182.17.4914 Arzt für Innere Medizin
  • 1182.17.4908 Universitätskliniken Erlangen
  • 1182.17.4904 Universitätsklinikum Essen
  • 1182.17.4924 Klinikum der J. W.-Goethe-Universität
  • 1182.17.4930 Universitätsklinikum Freiburg
  • 1182.17.4928 Facharzt für Innere Medizin/Rheumatologie
  • 1182.17.4916 Medizinisches Versorgungszentrum Hamburg
  • 1182.17.4929 Universitätsklinikum Eppendorf
  • 1182.17.4931 IPM Study Center GmbH
  • 1182.17.4920 Abteilung Klinische Immunologie
  • 1182.17.4909 Universitätsklinikum Heidelberg
  • 1182.17.4905 Universitätsklinik Köln
  • 1182.17.4926 Internist
  • 1182.17.4923 Facharzt für Innere Medizin,
  • 1182.17.4907 Medizinische Poliklinik
  • 1182.17.4910 MUC Research GmbH
  • 1182.17.4915 Klinium Natruper Holz
  • 1182.17.4921 Arzt für Allgemeinmedizin
  • 1182.17.3001 Boehringer Ingelheim Investigational Site
  • 1182.17.3002 Boehringer Ingelheim Investigational Site
  • 1182.17.3003 Boehringer Ingelheim Investigational Site
  • 1182.17.3004 Boehringer Ingelheim Investigational Site
  • 1182.17.3007 Boehringer Ingelheim Investigational Site
  • 1182.17.3010 Boehringer Ingelheim Investigational Site
  • 1182.17.3009 Boehringer Ingelheim Investigational Site
  • 1182.17.0409 Ospedale Santa Maria Annunziata
  • 1182.17.0413 Ospedale di Circolo di Busto
  • 1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna
  • 1182.17.0397 Ospedale San Martino
  • 1182.17.0412 S.C. Malattie Infettive
  • 1182.17.0411 Presidio Ospedaliero "A. Manzoni"
  • 1182.17.0389 Reparto Malattie Infettive
  • 1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor
  • 1182.17.0386 Policlinico Universitario
  • 1182.17.0388 Ospedale A. Cotugno
  • 1182.17.0385 IRCCS Policlinico San Matteo
  • 1182.17.0394 IRCCS Policlinico San Matteo
  • 1182.17.0395 Azienda Policlinico Umberto I
  • 1182.17.0419 I Cattedra Malattie Infettive
  • 1182.17.0387 Ospedale Amedeo di Savoia
  • 1182.17.0398 Ospedale Amedeo di Savoia
  • 1182.17.0415 U.O.A. Malattie Infettive B
  • 1182.17.5201 Centro Médico La Raza IMSS
  • 1182.17.5203 Hospital Civil Nuevo de Guadalajara
  • 1182.17.5206 Centro Medico San Vicente
  • 1182.17.3101 Boehringer Ingelheim Investigational Site
  • 1182.17.3108 Boehringer Ingelheim Investigational Site
  • 1182.17.3105 Boehringer Ingelheim Investigational Site
  • 1182.17.202 Boehringer Ingelheim Investigational Site
  • 1182.17.3502 Hospital Condes Castro Guimarães
  • 1182.17.705 Hospital Germans Trias i Pujol
  • 1182.17.701 Hospital Clínico y Provincial de Barcelona
  • 1182.17.703 Hospital 12 de Octubre
  • 1182.17.704 Hospital Ramón y Cajal.
  • 1182.17.710 Hospital Gregorio Maranon
  • 1182.17.712 Hospital Clínico San Carlos
  • 1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria
  • 1182.17.713 Hospital Universitario Vírgen del Rocío
  • 1182.17.714 Hospital General Universitario de Valencia
  • 1182.17.720 Hospital La Fe
  • 1182.17.718 Complejo Hospitalario Xeral - Cíes
  • 1182.17.4101 DIM / Abteilung für Infektiologie
  • 1182.17.4104 Département de médicine interne Div. Des maladies infectieus
  • 1182.17.4103 DIM / Abteilung für Infektiologie
  • 1182.17.4102 Departement für Innere Medizin
  • 1182.17.4405 Boehringer Ingelheim Investigational Site
  • 1182.17.4411 Boehringer Ingelheim Investigational Site
  • 1182.17.4404 Boehringer Ingelheim Investigational Site
  • 1182.17.4406 Boehringer Ingelheim Investigational Site
  • 1182.17.4408 Boehringer Ingelheim Investigational Site
  • 1182.17.4409 Boehringer Ingelheim Investigational Site
  • 1182.17.4414 Boehringer Ingelheim Investigational Site
  • 1182.17.4418 Boehringer Ingelheim Investigational Site
  • 1182.17.4407

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Patients With Varying Degrees of Tipranavir Treatment Experience

Highly Tipranavir Treatment Experienced Patients

Tipranavir Treatment Naive Patients

Outcomes

Primary Outcome Measures

Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
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.
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
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
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
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
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
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
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
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Adverse Events Leading to Death
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)
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)
Change from baseline in CD4 cell count with last observation carried forward(LOCF).

Full Information

First Posted
September 5, 2005
Last Updated
January 31, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00146328
Brief Title
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients With Varying Degrees of Tipranavir Treatment Experience
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Highly Tipranavir Treatment Experienced Patients
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Tipranavir Treatment Naive Patients
Intervention Type
Drug
Intervention Name(s)
Tipranavir
Primary Outcome Measure Information:
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Title
Number of Patients With Adverse Events Leading to Death
Description
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time Frame
End of Trial (>288 weeks)
Secondary Outcome Measure Information:
Title
Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)
Description
Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)
Time Frame
Baseline to 192-240 week time interval
Title
Change From Baseline in CD4 Cell Count (LOCF)
Description
Change from baseline in CD4 cell count with last observation carried forward(LOCF).
Time Frame
Baseline to 192-240 week time interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA 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. 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. Male and female subjects 18 years and over. 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. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator). 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 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. 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. 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. 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. 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). 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. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values. Hypersensitivity to tipranavir or ritonavir. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1182.17.39 MDS Pharma Services
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1182.17.75 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1182.17.89 Boehringer Ingelheim Investigational Site
City
Berkeley
State/Province
California
Country
United States
Facility Name
1182.17.60 Boehringer Ingelheim Investigational Site
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
1182.17.106 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.15 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.40 Tower ID Medical
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.46 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.47 University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.73 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.17.114 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1182.17.128 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1182.17.37 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.17.58 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.17.96 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.17.87 Boehringer Ingelheim Investigational Site
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
1182.17.112 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.17.43 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.17.65 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.17.126 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1182.17.8 Boehringer Ingelheim Investigational Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
1182.17.131 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1182.17.22 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1182.17.64 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1182.17.129 Boehringer Ingelheim Investigational Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
1182.17.51 Boehringer Ingelheim Investigational Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
1182.17.125 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1182.17.132 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1182.17.76 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1182.17.52 Boehringer Ingelheim Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
1182.17.77 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1182.17.69 Boehringer Ingelheim Investigational Site
City
Macon
State/Province
Georgia
Country
United States
Facility Name
1182.17.136 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1182.17.70 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1182.17.36 Boehringer Ingelheim Investigational Site
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
1182.17.1 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
1182.17.32 University of Kansas School of Medicine - Wichita
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1182.17.102 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
1182.17.21 Boehringer Ingelheim Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
1182.17.30 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Maine
Country
United States
Facility Name
1182.17.67 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1182.17.86 Boehringer Ingelheim Investigational Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
1182.17.111 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1182.17.63 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1182.17.74 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
1182.17.4 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
1182.17.115 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
1182.17.6 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
1182.17.62 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
1182.17.59 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1182.17.118 Early Intervention Program (EIP) Clinic
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
1182.17.93 Boehringer Ingelheim Investigational Site
City
East Orange
State/Province
New Jersey
Country
United States
Facility Name
1182.17.24 Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
1182.17.34 ID Care, Inc.
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
1182.17.50 Boehringer Ingelheim Investigational Site
City
Santa Fe
State/Province
New Mexico
Country
United States
Facility Name
1182.17.79 Boehringer Ingelheim Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
1182.17.103 Boehringer Ingelheim Investigational Site
City
Mount Vernon
State/Province
New York
Country
United States
Facility Name
1182.17.105 Pollari Medical Group
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.130 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.3 Division of Infectious Diseases
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.42 Beth Israel Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.5 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.7 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.94 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1182.17.135 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
1182.17.31 Boehringer Ingelheim Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
1182.17.53 Boehringer Ingelheim Investigational Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
1182.17.54 Boehringer Ingelheim Investigational Site
City
Huntersville
State/Province
North Carolina
Country
United States
Facility Name
1182.17.134 Summa Health System
City
Akron
State/Province
Ohio
Country
United States
Facility Name
1182.17.95 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1182.17.26 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1182.17.9 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1182.17.110 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1182.17.99 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1182.17.23 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
1182.17.11 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1182.17.18 Vanderbilt AIDS Clinical Trials Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
1182.17.116 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.17.142 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.17.16 Nelson-Tebedo Clinic
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.17.122 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1182.17.68 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1182.17.97 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1182.17.10 Boehringer Ingelheim Investigational Site
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
1182.17.92 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
1182.17.100 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
1182.17.5401 Fundacion Huesped
City
Capital Federal
Country
Argentina
Facility Name
1182.17.5402 Funcei
City
Capital Federal
Country
Argentina
Facility Name
1182.17.5403 consultorio externo "PETS"
City
Capital Federal
Country
Argentina
Facility Name
1182.17.5404 Infectología
City
Capital Federal
Country
Argentina
Facility Name
1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)
City
Capital Federal
Country
Argentina
Facility Name
1182.17.5406 Pabellón de Clínicas 2° Piso
City
Capital Federal
Country
Argentina
Facility Name
1182.17.401 St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.402 Taylor Square Private Clinic
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.405 AIDS Research Initiative
City
DarlingHurst
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.407 Holdsworth House General Practice
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.408 407 Doctors Pty Ltd.
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.403 Albion Street Clinic
City
Surry Hills
State/Province
New South Wales
Country
Australia
Facility Name
1182.17.404 Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
1182.17.4301 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1182.17.3209 Instituut Tropische Geneeskunde
City
Antwerpen
Country
Belgium
Facility Name
1182.17.3201 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.17.3202 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.17.3207 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1182.17.3210 Centre Hospitalier de Luxembourg
City
Luxembourg
Country
Belgium
Facility Name
1182.17.5511 Universidade Federal da Bahia
City
Canela - Salvador - BA
Country
Brazil
Facility Name
1182.17.5508 I.I. Emilio Ribas
City
Cerqueira César, São Paulo - SP
Country
Brazil
Facility Name
1182.17.5509 (Unidade de Testes Terapêuticos)
City
Cidade Nova - Rio de Janeiro - RJ
Country
Brazil
Facility Name
1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas
City
Manguinhos - Rio de Janeiro - RJ
Country
Brazil
Facility Name
1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC
City
Mercês - Curitiba - PR
Country
Brazil
Facility Name
1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
City
Nova Iguaçu - Rio de Janeiro - RJ
Country
Brazil
Facility Name
1182.17.5501 Hospital Dia
City
Sacoma - São Paulo - SP
Country
Brazil
Facility Name
1182.17.5503 Instituto de Infectologia Emílio Ribas
City
São Paulo - SP
Country
Brazil
Facility Name
1182.17.5504 Enfermaria de MI
City
São Paulo - SP
Country
Brazil
Facility Name
1182.17.5510 Casa de AIDS
City
São Paulo, SP
Country
Brazil
Facility Name
1182.17.5506 Centro de Referência e Treinamento - DST/AIDS
City
Vila Mariana, Sao Paulo - SP
Country
Brazil
Facility Name
1182.17.902 Downtown Infectious Diseases Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1182.17.913 McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1182.17.901 Division of Infectious Diseases
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.17.907 University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.17.910 Sunnybrook & Women's College Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.17.914 Montreal General Hospital - McGill University Health Centre
City
Monteal
State/Province
Quebec
Country
Canada
Facility Name
1182.17.903 Montreal Chest Institute, McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.17.904 Clinique Medicale Du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.17.915 Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.17.4505 Boehringer Ingelheim Investigational Site
City
Aarhus N
Country
Denmark
Facility Name
1182.17.4501 Boehringer Ingelheim Investigational Site
City
Copenhagen Ø
Country
Denmark
Facility Name
1182.17.4502 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1182.17.4504 Boehringer Ingelheim Investigational Site
City
Odense
Country
Denmark
Facility Name
1182.17.33011 Hôpital Pellegrin
City
Bordeaux cedex
Country
France
Facility Name
1182.17.33019 Hôpital Saint André
City
Bordeaux cedex
Country
France
Facility Name
1182.17.33020 Hôpital Côte de Nacre
City
Caen cedex 5
Country
France
Facility Name
1182.17.33007 Hôpital Antoine Beclere
City
Clamart
Country
France
Facility Name
1182.17.33008 Hôpital de l'Hôtel Dieu
City
Lyon cedex 2
Country
France
Facility Name
1182.17.33023 Hôpital Edouard Herriot
City
Lyon cedex 3
Country
France
Facility Name
1182.17.33012 Hôpital de la Conception
City
Marseille cedex 5
Country
France
Facility Name
1182.17.33013 Hôpital Sainte Marguerite
City
Marseille cedex 9
Country
France
Facility Name
1182.17.00336 Hôpital Hôtel Dieu
City
Nantes cedex 1
Country
France
Facility Name
1182.17.33010 Hôpital de l'Archet
City
Nice cedex 3
Country
France
Facility Name
1182.17.33024 Groupe Hospitalier Cochin
City
Paris cedex 14
Country
France
Facility Name
1182.17.33022 Hôpital Européen Georges Pompidou
City
Paris cedex 15
Country
France
Facility Name
1182.17.00335 Hôpital Bichat Claude Bernard
City
Paris cedex 18
Country
France
Facility Name
1182.17.00331 Hôpital Tenon
City
Paris cedex 20
Country
France
Facility Name
1182.17.00333 Hôpital Saint Louis
City
Paris
Country
France
Facility Name
1182.17.00334 Hôpital de la Pitié Salpêtrière
City
Paris
Country
France
Facility Name
1182.17.33014 Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
1182.17.33018 Hôpital de Pontchaillou
City
Rennes cedex 9
Country
France
Facility Name
1182.17.33016 Hôpital Civil
City
Strasbourg cedex
Country
France
Facility Name
1182.17.00332 Hôpital du Chalucet
City
Toulon
Country
France
Facility Name
1182.17.33017 Hôpital Brabois Adultes
City
Vandoeuvre les Nancy
Country
France
Facility Name
1182.17.33021 Hôpital Paul Brousse
City
Villejuif cedex
Country
France
Facility Name
1182.17.4911 Arzt für Innere Medizin
City
Aachen
Country
Germany
Facility Name
1182.17.4901 Epimed GmbH c/o
City
Berlin
Country
Germany
Facility Name
1182.17.4902 Charite, Campus Virchow-Klinikum
City
Berlin
Country
Germany
Facility Name
1182.17.4918 Rheinische Friedrich-Wilhelm-Universität
City
Bonn
Country
Germany
Facility Name
1182.17.4906 ID-Ambulanz Klinikum Dortmund
City
Dortmund
Country
Germany
Facility Name
1182.17.4912 Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
1182.17.4914 Arzt für Innere Medizin
City
Düsseldorf
Country
Germany
Facility Name
1182.17.4908 Universitätskliniken Erlangen
City
Erlangen
Country
Germany
Facility Name
1182.17.4904 Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
1182.17.4924 Klinikum der J. W.-Goethe-Universität
City
Frankfurt/Main
Country
Germany
Facility Name
1182.17.4930 Universitätsklinikum Freiburg
City
Freiburg/Breisgau
Country
Germany
Facility Name
1182.17.4928 Facharzt für Innere Medizin/Rheumatologie
City
Freiburg
Country
Germany
Facility Name
1182.17.4916 Medizinisches Versorgungszentrum Hamburg
City
Hamburg
Country
Germany
Facility Name
1182.17.4929 Universitätsklinikum Eppendorf
City
Hamburg
Country
Germany
Facility Name
1182.17.4931 IPM Study Center GmbH
City
Hamburg
Country
Germany
Facility Name
1182.17.4920 Abteilung Klinische Immunologie
City
Hannover
Country
Germany
Facility Name
1182.17.4909 Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
1182.17.4905 Universitätsklinik Köln
City
Köln
Country
Germany
Facility Name
1182.17.4926 Internist
City
Köln
Country
Germany
Facility Name
1182.17.4923 Facharzt für Innere Medizin,
City
Mannheim
Country
Germany
Facility Name
1182.17.4907 Medizinische Poliklinik
City
München
Country
Germany
Facility Name
1182.17.4910 MUC Research GmbH
City
München
Country
Germany
Facility Name
1182.17.4915 Klinium Natruper Holz
City
Osnabrück
Country
Germany
Facility Name
1182.17.4921 Arzt für Allgemeinmedizin
City
Stuttgart
Country
Germany
Facility Name
1182.17.3001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.17.3002 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.17.3003 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.17.3004 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.17.3007 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1182.17.3010 Boehringer Ingelheim Investigational Site
City
Patras
Country
Greece
Facility Name
1182.17.3009 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1182.17.0409 Ospedale Santa Maria Annunziata
City
Antella (fi)
Country
Italy
Facility Name
1182.17.0413 Ospedale di Circolo di Busto
City
Busto Arsizio (va)
Country
Italy
Facility Name
1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna
City
Ferrara
Country
Italy
Facility Name
1182.17.0397 Ospedale San Martino
City
Genova
Country
Italy
Facility Name
1182.17.0412 S.C. Malattie Infettive
City
Genova
Country
Italy
Facility Name
1182.17.0411 Presidio Ospedaliero "A. Manzoni"
City
Lecco
Country
Italy
Facility Name
1182.17.0389 Reparto Malattie Infettive
City
Macerata
Country
Italy
Facility Name
1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor
City
Milano
Country
Italy
Facility Name
1182.17.0386 Policlinico Universitario
City
Modena
Country
Italy
Facility Name
1182.17.0388 Ospedale A. Cotugno
City
Napoli
Country
Italy
Facility Name
1182.17.0385 IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
1182.17.0394 IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
1182.17.0395 Azienda Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
1182.17.0419 I Cattedra Malattie Infettive
City
Roma
Country
Italy
Facility Name
1182.17.0387 Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
1182.17.0398 Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
1182.17.0415 U.O.A. Malattie Infettive B
City
Torino
Country
Italy
Facility Name
1182.17.5201 Centro Médico La Raza IMSS
City
Col. La Raza, Mexico
Country
Mexico
Facility Name
1182.17.5203 Hospital Civil Nuevo de Guadalajara
City
Guadalajara
Country
Mexico
Facility Name
1182.17.5206 Centro Medico San Vicente
City
Monterrey, N.l., Mexico
Country
Mexico
Facility Name
1182.17.3101 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1182.17.3108 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1182.17.3105 Boehringer Ingelheim Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
1182.17.202 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1182.17.3502 Hospital Condes Castro Guimarães
City
Cascais
Country
Portugal
Facility Name
1182.17.705 Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
1182.17.701 Hospital Clínico y Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
1182.17.703 Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
1182.17.704 Hospital Ramón y Cajal.
City
Madrid
Country
Spain
Facility Name
1182.17.710 Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
1182.17.712 Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria
City
Malaga
Country
Spain
Facility Name
1182.17.713 Hospital Universitario Vírgen del Rocío
City
Sevilla
Country
Spain
Facility Name
1182.17.714 Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
1182.17.720 Hospital La Fe
City
Valencia
Country
Spain
Facility Name
1182.17.718 Complejo Hospitalario Xeral - Cíes
City
Vigo
Country
Spain
Facility Name
1182.17.4101 DIM / Abteilung für Infektiologie
City
Basel
Country
Switzerland
Facility Name
1182.17.4104 Département de médicine interne Div. Des maladies infectieus
City
Genève
Country
Switzerland
Facility Name
1182.17.4103 DIM / Abteilung für Infektiologie
City
St. Gallen
Country
Switzerland
Facility Name
1182.17.4102 Departement für Innere Medizin
City
Zürich
Country
Switzerland
Facility Name
1182.17.4405 Boehringer Ingelheim Investigational Site
City
Brighton
Country
United Kingdom
Facility Name
1182.17.4411 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
1182.17.4404 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4406 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4408 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4409 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4414 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4418 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1182.17.4407
City
Portsmouth
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.17_U09-3274.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.17_literature.pdf
Description
Related Info

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

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