AzTrials
AzTrials

HIV InfectionsPhase 2/3NCT00146328

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

A Phase 2/3 study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 233 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Tipranavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
997 participants
Where
233 sitesin 18 countries
Study dates
Apr 2001to May 2008
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

233 sites in 18 countries.

233 sites in 18 countries

United States86 sites

  • 1182.17.134 Summa Health System

    Akron, Ohio

  • 1182.17.79 Boehringer Ingelheim Investigational Site

    Albany, New York

  • 1182.17.4 Boehringer Ingelheim Investigational Site

    Ann Arbor, Michigan

  • 1182.17.10 Boehringer Ingelheim Investigational Site

    Annandale, Virginia

  • 1182.17.77 Boehringer Ingelheim Investigational Site

    Atlanta, Georgia

  • 1182.17.67 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 1182.17.89 Boehringer Ingelheim Investigational Site

    Berkeley, California

  • 1182.17.86 Boehringer Ingelheim Investigational Site

    Bethesda, Maryland

  • 1182.17.111 Boehringer Ingelheim Investigational Site

    Boston, Massachusetts

  • 1182.17.63 Boehringer Ingelheim Investigational Site

    Boston, Massachusetts

  • 1182.17.118 Early Intervention Program (EIP) Clinic

    Camden, New Jersey

  • 1182.17.136 Boehringer Ingelheim Investigational Site

    Chicago, Illinois

  • 1182.17.70 Boehringer Ingelheim Investigational Site

    Chicago, Illinois

  • 1182.17.95 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 1182.17.23 Boehringer Ingelheim Investigational Site

    Columbia, South Carolina

  • 1182.17.26 Boehringer Ingelheim Investigational Site

    Columbus, Ohio

  • 1182.17.116 Boehringer Ingelheim Investigational Site

    Dallas, Texas

  • 1182.17.142 Boehringer Ingelheim Investigational Site

    Dallas, Texas

  • 1182.17.16 Nelson-Tebedo Clinic

    Dallas, Texas

  • 1182.17.115 Boehringer Ingelheim Investigational Site

    Detroit, Michigan

  • 1182.17.6 Boehringer Ingelheim Investigational Site

    Detroit, Michigan

  • 1182.17.53 Boehringer Ingelheim Investigational Site

    Durham, North Carolina

  • 1182.17.93 Boehringer Ingelheim Investigational Site

    East Orange, New Jersey

  • 1182.17.36 Boehringer Ingelheim Investigational Site

    Evanston, Illinois

  • 1182.17.126 Boehringer Ingelheim Investigational Site

    Fort Lauderdale, Florida

  • 1182.17.8 Boehringer Ingelheim Investigational Site

    Fort Myers, Florida

  • 1182.17.60 Boehringer Ingelheim Investigational Site

    Fountain Valley, California

  • 1182.17.24 Hackensack University Medical Center

    Hackensack, New Jersey

  • 1182.17.34 ID Care, Inc.

    Hillsborough, New Jersey

  • 1182.17.122 Boehringer Ingelheim Investigational Site

    Houston, Texas

  • 1182.17.68 Boehringer Ingelheim Investigational Site

    Houston, Texas

  • 1182.17.54 Boehringer Ingelheim Investigational Site

    Huntersville, North Carolina

  • 1182.17.1 Boehringer Ingelheim Investigational Site

    Indianapolis, Indiana

  • 1182.17.62 Boehringer Ingelheim Investigational Site

    Kansas City, Missouri

  • 1182.17.59 Boehringer Ingelheim Investigational Site

    Las Vegas, Nevada

  • 1182.17.102 Boehringer Ingelheim Investigational Site

    Lexington, Kentucky

  • 1182.17.106 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1182.17.15 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1182.17.40 Tower ID Medical

    Los Angeles, California

  • 1182.17.46 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1182.17.47 University of Southern California

    Los Angeles, California

  • 1182.17.73 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1182.17.21 Boehringer Ingelheim Investigational Site

    Louisville, Kentucky

  • 1182.17.69 Boehringer Ingelheim Investigational Site

    Macon, Georgia

  • 1182.17.11 Boehringer Ingelheim Investigational Site

    Memphis, Tennessee

  • 1182.17.131 Boehringer Ingelheim Investigational Site

    Miami, Florida

  • 1182.17.22 Boehringer Ingelheim Investigational Site

    Miami, Florida

  • 1182.17.100 Boehringer Ingelheim Investigational Site

    Milwaukee, Wisconsin

  • 1182.17.103 Boehringer Ingelheim Investigational Site

    Mount Vernon, New York

  • 1182.17.18 Vanderbilt AIDS Clinical Trials Center

    Nashville, Tennessee

  • 1182.17.105 Pollari Medical Group

    New York, New York

  • 1182.17.130 Boehringer Ingelheim Investigational Site

    New York, New York

  • 1182.17.3 Division of Infectious Diseases

    New York, New York

  • 1182.17.42 Beth Israel Medical Center

    New York, New York

  • 1182.17.5 Boehringer Ingelheim Investigational Site

    New York, New York

  • 1182.17.7 Boehringer Ingelheim Investigational Site

    New York, New York

  • 1182.17.94 Boehringer Ingelheim Investigational Site

    New York, New York

  • 1182.17.87 Boehringer Ingelheim Investigational Site

    Norwalk, Connecticut

  • 1182.17.9 Boehringer Ingelheim Investigational Site

    Oklahoma City, Oklahoma

  • 1182.17.64 Boehringer Ingelheim Investigational Site

    Orlando, Florida

  • 1182.17.110 Boehringer Ingelheim Investigational Site

    Philadelphia, Pennsylvania

  • 1182.17.99 Boehringer Ingelheim Investigational Site

    Philadelphia, Pennsylvania

  • 1182.17.39 MDS Pharma Services

    Phoenix, Arizona

  • 1182.17.75 Boehringer Ingelheim Investigational Site

    Phoenix, Arizona

  • 1182.17.30 Boehringer Ingelheim Investigational Site

    Portland, Maine

  • 1182.17.135 Boehringer Ingelheim Investigational Site

    Rochester, New York

  • 1182.17.97 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • 1182.17.114 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 1182.17.128 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 1182.17.37 Boehringer Ingelheim Investigational Site

    San Francisco, California

  • 1182.17.58 Boehringer Ingelheim Investigational Site

    San Francisco, California

  • 1182.17.96 Boehringer Ingelheim Investigational Site

    San Francisco, California

  • 1182.17.50 Boehringer Ingelheim Investigational Site

    Santa Fe, New Mexico

  • 1182.17.129 Boehringer Ingelheim Investigational Site

    Sarasota, Florida

  • 1182.17.51 Boehringer Ingelheim Investigational Site

    South Miami, Florida

  • 1182.17.74 Boehringer Ingelheim Investigational Site

    Springfield, Massachusetts

  • 1182.17.31 Boehringer Ingelheim Investigational Site

    Stony Brook, New York

  • 1182.17.92 Boehringer Ingelheim Investigational Site

    Tacoma, Washington

  • 1182.17.125 Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • 1182.17.132 Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • 1182.17.76 Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • 1182.17.52 Boehringer Ingelheim Investigational Site

    Vero Beach, Florida

  • 1182.17.112 Boehringer Ingelheim Investigational Site

    Washington D.C., District of Columbia

  • 1182.17.43 Boehringer Ingelheim Investigational Site

    Washington D.C., District of Columbia

  • 1182.17.65 Boehringer Ingelheim Investigational Site

    Washington D.C., District of Columbia

  • 1182.17.32 University of Kansas School of Medicine - Wichita

    Wichita, Kansas

Other trials in United States

Germany24 sites

  • 1182.17.4911 Arzt für Innere Medizin

    Aachen

  • 1182.17.4901 Epimed GmbH c/o

    Berlin

  • 1182.17.4902 Charite, Campus Virchow-Klinikum

    Berlin

  • 1182.17.4918 Rheinische Friedrich-Wilhelm-Universität

    Bonn

  • 1182.17.4905 Universitätsklinik Köln

    Cologne

  • 1182.17.4926 Internist

    Cologne

  • 1182.17.4906 ID-Ambulanz Klinikum Dortmund

    Dortmund

  • 1182.17.4912 Universitätsklinikum Düsseldorf

    Düsseldorf

  • 1182.17.4914 Arzt für Innere Medizin

    Düsseldorf

  • 1182.17.4908 Universitätskliniken Erlangen

    Erlangen

  • 1182.17.4904 Universitätsklinikum Essen

    Essen

  • 1182.17.4924 Klinikum der J. W.-Goethe-Universität

    Frankfurt am Main

  • 1182.17.4928 Facharzt für Innere Medizin/Rheumatologie

    Freiburg im Breisgau

  • 1182.17.4930 Universitätsklinikum Freiburg

    Freiburg/Breisgau

  • 1182.17.4916 Medizinisches Versorgungszentrum Hamburg

    Hamburg

  • 1182.17.4929 Universitätsklinikum Eppendorf

    Hamburg

  • 1182.17.4931 IPM Study Center GmbH

    Hamburg

  • 1182.17.4920 Abteilung Klinische Immunologie

    Hanover

  • 1182.17.4909 Universitätsklinikum Heidelberg

    Heidelberg

  • 1182.17.4923 Facharzt für Innere Medizin,

    Mannheim

  • 1182.17.4907 Medizinische Poliklinik

    München

  • 1182.17.4910 MUC Research GmbH

    München

  • 1182.17.4915 Klinium Natruper Holz

    Osnabrück

  • 1182.17.4921 Arzt für Allgemeinmedizin

    Stuttgart

Other trials in Germany

France22 sites

  • 1182.17.33011 Hôpital Pellegrin

    Bordeaux

  • 1182.17.33019 Hôpital Saint André

    Bordeaux

  • 1182.17.33020 Hôpital Côte de Nacre

    Caen

  • 1182.17.33007 Hôpital Antoine Beclere

    Clamart

  • 1182.17.33008 Hôpital de l'Hôtel Dieu

    Lyon

  • 1182.17.33023 Hôpital Edouard Herriot

    Lyon

  • 1182.17.33012 Hôpital de la Conception

    Marseille

  • 1182.17.33013 Hôpital Sainte Marguerite

    Marseille

  • 1182.17.00336 Hôpital Hôtel Dieu

    Nantes

  • 1182.17.33010 Hôpital de l'Archet

    Nice

  • 1182.17.00331 Hôpital Tenon

    Paris

  • 1182.17.00333 Hôpital Saint Louis

    Paris

  • 1182.17.00334 Hôpital de la Pitié Salpêtrière

    Paris

  • 1182.17.00335 Hôpital Bichat Claude Bernard

    Paris

  • 1182.17.33014 Hôpital Saint Antoine

    Paris

  • 1182.17.33022 Hôpital Européen Georges Pompidou

    Paris

  • 1182.17.33024 Groupe Hospitalier Cochin

    Paris

  • 1182.17.33018 Hôpital de Pontchaillou

    Rennes

  • 1182.17.33016 Hôpital Civil

    Strasbourg

  • 1182.17.00332 Hôpital du Chalucet

    Toulon

  • 1182.17.33017 Hôpital Brabois Adultes

    Vandœuvre-lès-Nancy

  • 1182.17.33021 Hôpital Paul Brousse

    Villejuif

Other trials in France

Italy17 sites

  • 1182.17.0409 Ospedale Santa Maria Annunziata

    Antella (fi)

  • 1182.17.0413 Ospedale di Circolo di Busto

    Busto Arsizio (va)

  • 1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna

    Ferrara

  • 1182.17.0397 Ospedale San Martino

    Genova

  • 1182.17.0412 S.C. Malattie Infettive

    Genova

  • 1182.17.0411 Presidio Ospedaliero "A. Manzoni"

    Lecco

  • 1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor

    Milan

  • 1182.17.0386 Policlinico Universitario

    Modena

  • 1182.17.0388 Ospedale A. Cotugno

    Naples

  • 1182.17.0385 IRCCS Policlinico San Matteo

    Pavia

  • 1182.17.0394 IRCCS Policlinico San Matteo

    Pavia

  • 1182.17.0389 Reparto Malattie Infettive

    Province of Macerata

  • 1182.17.0395 Azienda Policlinico Umberto I

    Roma

  • 1182.17.0419 I Cattedra Malattie Infettive

    Roma

  • 1182.17.0387 Ospedale Amedeo di Savoia

    Torino

  • 1182.17.0398 Ospedale Amedeo di Savoia

    Torino

  • 1182.17.0415 U.O.A. Malattie Infettive B

    Torino

Other trials in Italy

Brazil11 sites

  • 1182.17.5511 Universidade Federal da Bahia

    Canela - Salvador - BA

  • 1182.17.5508 I.I. Emilio Ribas

    Cerqueira César, São Paulo - SP

  • 1182.17.5509 (Unidade de Testes Terapêuticos)

    Cidade Nova - Rio de Janeiro - RJ

  • 1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas

    Manguinhos - Rio de Janeiro - RJ

  • 1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC

    Mercês - Curitiba - PR

  • 1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde

    Nova Iguaçu - Rio de Janeiro - RJ

  • 1182.17.5501 Hospital Dia

    Sacoma - São Paulo - SP

  • 1182.17.5503 Instituto de Infectologia Emílio Ribas

    São Paulo - SP

  • 1182.17.5504 Enfermaria de MI

    São Paulo - SP

  • 1182.17.5510 Casa de AIDS

    São Paulo, SP

  • 1182.17.5506 Centro de Referência e Treinamento - DST/AIDS

    Vila Mariana, Sao Paulo - SP

Other trials in Brazil

Canada11 sites

  • 1182.17.913 McMaster University Medical Centre

    Hamilton, Ontario

  • 1182.17.914 Montreal General Hospital - McGill University Health Centre

    Monteal, Quebec

  • 1182.17.903 Montreal Chest Institute, McGill University Health Centre

    Montreal, Quebec

  • 1182.17.904 Clinique Medicale Du Quartier Latin

    Montreal, Quebec

  • 1182.17.915 Clinique medicale l'Actuel

    Montreal, Quebec

  • 1182.17.901 Division of Infectious Diseases

    Ottawa, Ontario

  • 1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.

    Toronto, Ontario

  • 1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital

    Toronto, Ontario

  • 1182.17.907 University Health Network - Toronto General Hospital

    Toronto, Ontario

  • 1182.17.910 Sunnybrook & Women's College Health Science Centre

    Toronto, Ontario

  • 1182.17.902 Downtown Infectious Diseases Clinic

    Vancouver, British Columbia

Other trials in Canada

Spain11 sites

  • 1182.17.705 Hospital Germans Trias i Pujol

    Badalona

  • 1182.17.701 Hospital Clínico y Provincial de Barcelona

    Barcelona

  • 1182.17.703 Hospital 12 de Octubre

    Madrid

  • 1182.17.704 Hospital Ramón y Cajal.

    Madrid

  • 1182.17.710 Hospital Gregorio Maranon

    Madrid

  • 1182.17.712 Hospital Clínico San Carlos

    Madrid

  • 1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria

    Málaga

  • 1182.17.713 Hospital Universitario Vírgen del Rocío

    Seville

  • 1182.17.714 Hospital General Universitario de Valencia

    Valencia

  • 1182.17.720 Hospital La Fe

    Valencia

  • 1182.17.718 Complejo Hospitalario Xeral - Cíes

    Vigo

Other trials in Spain

United Kingdom9 sites

  • 1182.17.4405 Boehringer Ingelheim Investigational Site

    Brighton

  • 1182.17.4411 Boehringer Ingelheim Investigational Site

    Liverpool

  • 1182.17.4404 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4406 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4408 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4409 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4414 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4418 Boehringer Ingelheim Investigational Site

    London

  • 1182.17.4407

    Portsmouth

Other trials in United Kingdom

Australia7 sites

  • 1182.17.401 St. Vincent's Hospital

    Darlinghurst, New South Wales

  • 1182.17.402 Taylor Square Private Clinic

    Darlinghurst, New South Wales

  • 1182.17.405 AIDS Research Initiative

    Darlinghurst, New South Wales

  • 1182.17.407 Holdsworth House General Practice

    Darlinghurst, New South Wales

  • 1182.17.408 407 Doctors Pty Ltd.

    Darlinghurst, New South Wales

  • 1182.17.404 Alfred Hospital

    Melbourne, Victoria

  • 1182.17.403 Albion Street Clinic

    Surry Hills, New South Wales

Other trials in Australia

Greece7 sites

  • 1182.17.3001 Boehringer Ingelheim Investigational Site

    Athens

  • 1182.17.3002 Boehringer Ingelheim Investigational Site

    Athens

  • 1182.17.3003 Boehringer Ingelheim Investigational Site

    Athens

  • 1182.17.3004 Boehringer Ingelheim Investigational Site

    Athens

  • 1182.17.3007 Boehringer Ingelheim Investigational Site

    Athens

  • 1182.17.3010 Boehringer Ingelheim Investigational Site

    Pátrai

  • 1182.17.3009 Boehringer Ingelheim Investigational Site

    Thessaloniki

Other trials in Greece

Argentina6 sites

  • 1182.17.5401 Fundacion Huesped

    Capital Federal

  • 1182.17.5402 Funcei

    Capital Federal

  • 1182.17.5403 consultorio externo "PETS"

    Capital Federal

  • 1182.17.5404 Infectología

    Capital Federal

  • 1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)

    Capital Federal

  • 1182.17.5406 Pabellón de Clínicas 2° Piso

    Capital Federal

Other trials in Argentina

Belgium5 sites

  • 1182.17.3209 Instituut Tropische Geneeskunde

    Antwerp

  • 1182.17.3201 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.17.3202 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.17.3207 Boehringer Ingelheim Investigational Site

    Ghent

  • 1182.17.3210 Centre Hospitalier de Luxembourg

    Luxembourg

Other trials in Belgium

Denmark4 sites

  • 1182.17.4505 Boehringer Ingelheim Investigational Site

    Aarhus N

  • 1182.17.4501 Boehringer Ingelheim Investigational Site

    Copenhagen Ø

  • 1182.17.4502 Boehringer Ingelheim Investigational Site

    Hvidovre

  • 1182.17.4504 Boehringer Ingelheim Investigational Site

    Odense

Other trials in Denmark

Netherlands4 sites

  • 1182.17.3101 Boehringer Ingelheim Investigational Site

    Amsterdam

  • 1182.17.3108 Boehringer Ingelheim Investigational Site

    Groningen

  • 1182.17.3105 Boehringer Ingelheim Investigational Site

    Nijmegen

  • 1182.17.202 Boehringer Ingelheim Investigational Site

    Rotterdam

Other trials in Netherlands

Switzerland4 sites

  • 1182.17.4101 DIM / Abteilung für Infektiologie

    Basel

  • 1182.17.4104 Département de médicine interne Div. Des maladies infectieus

    Geneva

  • 1182.17.4103 DIM / Abteilung für Infektiologie

    Sankt Gallen

  • 1182.17.4102 Departement für Innere Medizin

    Zurich

Other trials in Switzerland

Mexico3 sites

  • 1182.17.5201 Centro Médico La Raza IMSS

    Col. La Raza, Mexico

  • 1182.17.5203 Hospital Civil Nuevo de Guadalajara

    Guadalajara

  • 1182.17.5206 Centro Medico San Vicente

    Monterrey, N.l., Mexico

Other trials in Mexico

Austria1 site

  • 1182.17.4301 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

Portugal1 site

  • 1182.17.3502 Hospital Condes Castro Guimarães

    Cascais

Other trials in Portugal

About this study

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

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.

Conditions
HIV Infections
Being tested
Tipranavir
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TipranavirDrug

Study groups in NCT00146328
Study groupRoleWhat they receive
Group 1ExperimentalPatients With Varying Degrees of Tipranavir Treatment Experience
Receives: Drug: Tipranavir
Group 2ExperimentalHighly Tipranavir Treatment Experienced Patients
Receives: Drug: Tipranavir
Group 3ExperimentalTipranavir Treatment Naive Patients
Receives: Drug: Tipranavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: End of Trial (>288 weeks)

  2. 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.

    Measured: End of Trial (>288 weeks)

  3. 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.

    Measured: End of Trial (>288 weeks)

  4. 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.

    Measured: End of Trial (>288 weeks)

  5. 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.

    Measured: End of Trial (>288 weeks)

  6. 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.

    Measured: End of Trial (>288 weeks)

  7. 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.

    Measured: End of Trial (>288 weeks)

  8. 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.

    Measured: End of Trial (>288 weeks)

  9. 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.

    Measured: End of Trial (>288 weeks)

  10. 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.

    Measured: End of Trial (>288 weeks)

  11. 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.

    Measured: End of Trial (>288 weeks)

  12. 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.

    Measured: End of Trial (>288 weeks)

  13. 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.

    Measured: End of Trial (>288 weeks)

  14. 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.

    Measured: End of Trial (>288 weeks)

  15. 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.

    Measured: End of Trial (>288 weeks)

  16. 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.

    Measured: End of Trial (>288 weeks)

  17. 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.

    Measured: End of Trial (>288 weeks)

  18. 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.

    Measured: End of Trial (>288 weeks)

  19. 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.

    Measured: End of Trial (>288 weeks)

  20. 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.

    Measured: End of Trial (>288 weeks)

  21. 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.

    Measured: End of Trial (>288 weeks)

  22. 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.

    Measured: End of Trial (>288 weeks)

  23. 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.

    Measured: End of Trial (>288 weeks)

  24. Number of Patients With Adverse Events Leading to Death

    NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.

    Measured: End of Trial (>288 weeks)

Secondary outcomes (2)

  1. 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)

    Measured: Baseline to 192-240 week time interval

  2. Change From Baseline in CD4 Cell Count (LOCF)

    Change from baseline in CD4 cell count with last observation carried forward(LOCF).

    Measured: Baseline to 192-240 week time interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startApr 2001
  3. Primary completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146328
Sponsor's protocol ID
1182.17
Status last verified
Jan 2014
First submitted
5 Sep 2005
Last updated
6 Mar 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 233 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in United States, Germany, France, Italy, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin (time frame: End of Trial (>288 weeks)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in