Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00056641
First received: March 19, 2003
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).


Condition Intervention Phase
HIV Infections
Drug: tipranavir
Drug: ritonavir
Drug: saquinavir
Drug: amprenavir
Drug: lopinavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) [ Time Frame: Day 14 to Day 28 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) [ Time Frame: Week 1 and 2 ] [ Designated as safety issue: No ]
  • Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) [ Time Frame: Week 3 and 4 ] [ Designated as safety issue: No ]
  • Assessment of patient adherence [ Time Frame: Week 1 to 4 ] [ Designated as safety issue: No ]
  • Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • Change in viral load; Proportion of virologic responders [ Time Frame: week 2, 4, 8, 16 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 328
Study Start Date: January 2003
Primary Completion Date: January 2004 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00056641

  Hide Study Locations
Locations
United States, Arizona
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
Boehringer Ingelheim Investigational Site
Berkeley, California, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
San Francisco, California, United States
San Francisco VAMC
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
United States, Connecticut
Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States
United States, Florida
North Broward Hospital District
Fort Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site
Fort Myers, Florida, United States
Boehringer Ingelheim Investigational Site
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
United States, Georgia
Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States
United States, Massachusetts
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, 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
Boehringer Ingelheim Investigational Site
New York, New York, United States
University of New York, 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
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
UT Southwestern
Dallas, Texas, United States
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Virginia
Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
United States, Washington
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Australia, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
Belgium
Instituut Tropische Geneeskunde
Antwerpen, Belgium
Centre Hospitalier Universitaire St. Pierre
Bruxelles, Belgium
U.Z. Gent
Gent, Belgium
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario, Canada
Canada, Quebec
McGill University Health Centre, Suite A5-140
Monteal, Quebec, Canada
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Denmark
Hvidovre Hospital
Hvidovre, Denmark
Rigshospitalet
København Ø, Denmark
Odense Universitetshospital
Odense C, Denmark
France
Hôpital Pellegrin
Bordeaux cedex, France
Hôpital Côte de Nacre
Caen, France
Hôpital Antoine Beclère
Clamart, France
Hôpital de l'Hôtel Dieu
Lyon Cedex 2, France
Hôpital Hôtel Dieu
Nantes, France
Hôpital de l'Archet
Nice cedex 3, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital de la Pité Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Bichat Claude Bernard
Paris cedex 18, France
Hôpital de Pontchaillou
Rennes cedex 9, France
Hôpital civil
Strasbourg, France
Hôpital brabois
Vandoeuvre les nancy, France
Hôpital Paul Brousse
Villejuif, France
Germany
Boehringer Ingelheim Investigational Site
Aachen, Germany
Universitätsklinikum Charité
Berlin, Germany
Epimed GmbH
Berlin, Germany
Medizinische Universitätsklinik Bonn
Bonn, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
Universitätsklinik Erlangen-Nürnberg
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt/Main, Germany
Universitätsklinkum Freiburg
Freiburg, Germany
Boehringer Ingelheim Investigational Site
Freiburg, Germany
Universitätsklinik Hamburg-Eppendorf
Hamburg, Germany
ifi Institut für interdisziplinäre Infektiologie
Hamburg, Germany
Med. Hochschule Hannover
Hannover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinik I für Innere Medizin der
Köln, Germany
Facharzt für Innere Medizin,
Mannheim, Germany
Medizinische Poliklinik
München, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Klinium Natruper Holz
Osnabrück, Germany
Boehringer Ingelheim Investigational Site
Stuttgart, Germany
Greece
Korgialenio-Benakio-Hellenic Red Cross General Hospital
Athens, Greece
Andreas Syggros Hosp.
Athens, Greece
Sismanoglio Hospital
Athens, Greece
1st Social Insurance Foundation (IKA) Pentelis
Athens, Greece
General Hospital "G. Gennimatas"
Athens, Greece
Evangelismos Hospital
Athens, Greece
University Hospital of Patras
Patras, Greece
"Tzanio" Hospital
Piraeus, Greece
AHEPA Hospital
Thessaloniki, Greece
Italy
Fondazione S. Raffaele del Monte Tabor
Milano, Italy
Ospedale Amedeo di Savoia
Torino, Italy
Netherlands
OLVG
Amsterdam, Netherlands
Slotervaart Hospital
Amsterdam, Netherlands
Medical Centre Haaglanden
Den Haag, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Portugal
Hospital Condes Castro Guimarães
Cascais, Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Department of Infeccious Diseases
Lisbon, Portugal
Hospital de São João
Porto, Portugal
Switzerland
Universitätsspital Basel
Basel, Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
United Kingdom
St Mary's Hospital
London, United Kingdom
SSAT/Crusaid Institute
London, United Kingdom
Royal Free Hospital
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: NCT00056641     History of Changes
Other Study ID Numbers: 1182.51
Study First Received: March 19, 2003
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 31, 2014