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3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00275444
First received: January 9, 2006
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Virologic response after 2 weeks of functional monotherapy

Secondary Outcome Measures:
  • Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.

Enrollment: 216
Study Start Date: March 2002
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275444

  Hide Study Locations
Locations
United States, Arizona
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Living Hope Clinical Trials, Inc.
Long Beach, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, District of Columbia
Vincent Lombardi Cancer Center
Washington, D.C., District of Columbia, United States
United States, Florida
Therafirst Medical Center
Fort Lauderdale, Florida, United States
1501 N.W. 9th Ave
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Boehringer Ingelheim Investigational Site
South Miami, Florida, United States
Hillsborough County Health Dept.
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
United States, Georgia
Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
United States, Illinois
CORE Center
Chicago, Illinois, United States
Rush-Presbytarian-St Luke's Medical Center
Chicago, Illinois, United States
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States
United States, Louisiana
HIV Outpatient Program (H.O.P)
New Orleans, Louisiana, United States
United States, Maryland
John's Hopkins University
Baltimore, Maryland, United States
United States, Massachusetts
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Community Research Initiative of New England
Springfield, Massachusetts, United States
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States
United States, Missouri
Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
United States, Nevada
Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States
United States, New Mexico
Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico, United States
United States, New York
Albany Medical College
Albany, New York, United States
University of New York at Stony Brook
Stony Brook, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States
United States, Oklahoma
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, South Carolina
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Virginia
Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Australia, New South Wales
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Canada, Ontario
Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada
France
Hôpital de Bicêtre
Le Kremlin Bicêtre cedex, France
Hôpital de Chauliac
Montpellier cedex 5, France
Hôpital Hôtel Dieu
Nantes cedex 1, France
Hôpital Saint Louis
Paris cedex 10, France
Hôpital de la pitié Salpetrière
Paris cedex 13, France
Hôpital Bichat Claude Bernard
Paris cedex 18, France
Germany
Epimed GmbH
Berlin, Germany
Klinikum der J.-W.-Goethe-Universität
Frankfurt/Main, Germany
Klinik I für Innere Medizin der
Köln, Germany
Medizinische Poliklinik
München, Germany
Italy
Fondazione Centro S. Raffaele del Monte Tabor
Milano, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Spain
Hospital Clínico y Provincial de Barcelona - HIV
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Hospital La Paz.
Madrid, Spain
Hospital Ramón y Cajal.
Madrid, Spain
United Kingdom
4th Floor Research Office (St Stephens Centre)
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00275444     History of Changes
Other Study ID Numbers: 1182.52
Study First Received: January 9, 2006
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014