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

November 30, 2023 updated by: Boehringer Ingelheim

Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Signed informed consent prior to trial participation.
  • Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.
  • At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
  • Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
  • HIV-1 viral load ≥1000 copies/mL at screening.
  • Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
  • Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
  • Acceptable screening laboratory values that indicate adequate baseline organ function.
  • Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
  • Further inclusion criteria apply.

Exclusion criteria:

  • ARV medication naïve.
  • Only one or no available ARV medications as determined by genotypic resistance testing.

  • Female subjects who:

    • have a positive serum pregnancy test at screening or during the study;
    • are breast feeding;
    • are planning to become pregnant;
    • are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
  • Any active opportunistic infection within 60 days before study entry.
  • Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade 1.
  • Prior tipranavir use.
  • Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
  • Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
  • Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Virologic response after 2 weeks of functional monotherapy
Time Frame: At week 2
At week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2002

Primary Completion (Actual)

January 20, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimated)

January 12, 2006

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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