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

Primary Purpose

HIV Infections

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

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Living Hope Clinical Trials, Inc.
  • Boehringer Ingelheim Investigational Site
  • David Geffen School of Medicine at UCLA
  • Vincent Lombardi Cancer Center
  • Therafirst Medical Center
  • 1501 N.W. 9th Ave
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Hillsborough County Health Dept.
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Atlanta VA Medical Center
  • Mercer University School of Medicine
  • CORE Center
  • Rush-Presbytarian-St Luke's Medical Center
  • University of Louisville
  • HIV Outpatient Program (H.O.P)
  • John's Hopkins University
  • Boehringer Ingelheim Investigational Site
  • Community Research Initiative of New England
  • University of Michigan Health System
  • Boehringer Ingelheim Investigational Site
  • Washington University
  • Boehringer Ingelheim Investigational Site
  • ID Care
  • Boehringer Ingelheim Investigational Site
  • Albany Medical College
  • University of New York at Stony Brook
  • Duke University Medical Center
  • Boehringer Ingelheim Investigational Site
  • Wake Forest University Baptist Medical Center
  • Ohio State University Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • St. Vincent's Hospital
  • Boehringer Ingelheim Investigational Site
  • Toronto General Hospital
  • Montreal Chest Institute - McGill University Health Centre
  • Hôpital de Bicêtre
  • Hôpital de Chauliac
  • Hôpital Hôtel Dieu
  • Hôpital Saint Louis
  • Hôpital de la pitié Salpetrière
  • Hôpital Bichat Claude Bernard
  • Epimed GmbH
  • Klinikum der J.-W.-Goethe-Universität
  • Klinik I für Innere Medizin der
  • Medizinische Poliklinik
  • Fondazione Centro S. Raffaele del Monte Tabor
  • IRCCS Policlinico San Matteo
  • Academisch Medisch Centrum
  • Erasmus Medical Centre
  • Hospital Clínico y Provincial de Barcelona - HIV
  • Boehringer Ingelheim Investigational Site
  • Hospital La Paz.
  • Hospital Ramón y Cajal.
  • 4th Floor Research Office (St Stephens Centre)

Outcomes

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.

Full Information

First Posted
January 9, 2006
Last Updated
November 4, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00275444
Brief Title
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

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
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tipranavir
Primary Outcome Measure Information:
Title
Virologic response after 2 weeks of functional monotherapy
Secondary Outcome Measure Information:
Title
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Living Hope Clinical Trials, Inc.
City
Long Beach
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Vincent Lombardi Cancer Center
City
Washington, D.C.
State/Province
District of Columbia
Country
United States
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1501 N.W. 9th Ave
City
Miami
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Hillsborough County Health Dept.
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Mercer University School of Medicine
City
Macon
State/Province
Georgia
Country
United States
Facility Name
CORE Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Rush-Presbytarian-St Luke's Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
HIV Outpatient Program (H.O.P)
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
John's Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Community Research Initiative of New England
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Washington University
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Santa Fe
State/Province
New Mexico
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
Country
United States
Facility Name
University of New York at Stony Brook
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Huntersville
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institute - McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital de Bicêtre
City
Le Kremlin Bicêtre cedex
Country
France
Facility Name
Hôpital de Chauliac
City
Montpellier cedex 5
Country
France
Facility Name
Hôpital Hôtel Dieu
City
Nantes cedex 1
Country
France
Facility Name
Hôpital Saint Louis
City
Paris cedex 10
Country
France
Facility Name
Hôpital de la pitié Salpetrière
City
Paris cedex 13
Country
France
Facility Name
Hôpital Bichat Claude Bernard
City
Paris cedex 18
Country
France
Facility Name
Epimed GmbH
City
Berlin
Country
Germany
Facility Name
Klinikum der J.-W.-Goethe-Universität
City
Frankfurt/Main
Country
Germany
Facility Name
Klinik I für Innere Medizin der
City
Köln
Country
Germany
Facility Name
Medizinische Poliklinik
City
München
Country
Germany
Facility Name
Fondazione Centro S. Raffaele del Monte Tabor
City
Milano
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Clínico y Provincial de Barcelona - HIV
City
Barcelona
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
Hospital La Paz.
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal.
City
Madrid
Country
Spain
Facility Name
4th Floor Research Office (St Stephens Centre)
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.52_U03-3236.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.52_literature.pdf
Description
Related Info

Learn more about this trial

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

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