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

NCT00056641 | Completed Phase 2

• 1 other identifier: 1182.51
• Study Type: interventional
• Target: 328
• Locations: 13 countries
• Sites: 109

Brief Summary

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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)

  Day 14 to Day 28

• Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs

  week 4

Secondary Outcomes (8)

• Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)

  Week 1 and 2

• Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)

  Week 3 and 4

• Assessment of patient adherence

  Week 1 to 4

• 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)

  week 2 and 4

• 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

  week 4

Interventions

tipranavir DRUG

ritonavir DRUG

saquinavir DRUG

amprenavir DRUG

lopinavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to trial participation.
• Human Immunodeficiency Virus type 1 (HIV-1) infected males or females ≥18 years of age.
• Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype.
• Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and 90.
• At least 3 consecutive months experience taking ARVs from each of the classes of Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in treatment history, with at least 2 PI-based regimens, one of which must be part of the current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at least 3 months prior to randomization.
• HIV-1 viral load ≥1000 copies/mL at screening.

You may not qualify if:

• Anti-retroviral (ARV) medication naïve.
• Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
• Female patients of child-bearing potential 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 a use barrier method of contraception, or
• require ethinyl estradiol administration.
• Prior tipranavir use.
• Use of investigational medications within 30 days before study entry or during the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (109)

Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

Kaiser Permanente Medical Center

San Francisco, California, United States

Location

San Francisco VAMC

San Francisco, California, United States

Location

Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Location

North Broward Hospital District

Fort Lauderdale, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

Mercer University School of Medicine

Macon, Georgia, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, United States

Location

Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

Boehringer Ingelheim Investigational Site

Santa Fe, New Mexico, United States

Location

Albany Medical College

Albany, New York, United States

Location

Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

University of New York, Stony Brook

Stony Brook, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

UT Southwestern

Dallas, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Annandale, Virginia, United States

Location

Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

Boehringer Ingelheim Investigational Site

Darlinghurst, New South Wales, Australia

Location

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Location

Instituut Tropische Geneeskunde

Antwerp, Belgium

Location

Centre Hospitalier Universitaire St. Pierre

Brussels, Belgium

Location

U.Z. Gent

Ghent, Belgium

Location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

Canadian Immunodeficiency Research Collaborative Inc.

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

McGill University Health Centre, Suite A5-140

Monteal, Quebec, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

Montreal Chest Institute - McGill University Health Centre

Montreal, Quebec, Canada

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Rigshospitalet

København Ø, Denmark

Location

Odense Universitetshospital

Odense C, Denmark

Location

Hôpital Pellegrin

Bordeaux, France

Location

Hôpital Côte de Nacre

Caen, France

Location

Hôpital Antoine Beclère

Clamart, France

Location

Hôpital de l'Hôtel Dieu

Lyon, France

Location

Hôpital Hôtel Dieu

Nantes, France

Location

Hôpital de l'Archet

Nice, France

Location

Hôpital Bichat Claude Bernard

Paris, France

Location

Hôpital de la Pité Salpêtrière

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Hôpital de Pontchaillou

Rennes, France

Location

Hôpital civil

Strasbourg, France

Location

Hôpital brabois

Vandœuvre-lès-Nancy, France

Location

Hôpital Paul Brousse

Villejuif, France

Location

Boehringer Ingelheim Investigational Site

Aachen, Germany

Location

Epimed GmbH

Berlin, Germany

Location

Universitätsklinikum Charité

Berlin, Germany

Location

Medizinische Universitätsklinik Bonn

Bonn, Germany

Location

Klinik I für Innere Medizin der

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinik Erlangen-Nürnberg

Erlangen, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, Germany

Location

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

Universitätsklinkum Freiburg

Freiburg im Breisgau, Germany

Location

ifi Institut für interdisziplinäre Infektiologie

Hamburg, Germany

Location

Universitätsklinik Hamburg-Eppendorf

Hamburg, Germany

Location

Med. Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Facharzt für Innere Medizin,

Mannheim, Germany

Location

Boehringer Ingelheim Investigational Site

München, Germany

Location

Medizinische Poliklinik

München, Germany

Location

Klinium Natruper Holz

Osnabrück, Germany

Location

Boehringer Ingelheim Investigational Site

Stuttgart, Germany

Location

1st Social Insurance Foundation (IKA) Pentelis

Athens, Greece

Location

Andreas Syggros Hosp.

Athens, Greece

Location

Evangelismos Hospital

Athens, Greece

Location

General Hospital "G. Gennimatas"

Athens, Greece

Location

Korgialenio-Benakio-Hellenic Red Cross General Hospital

Athens, Greece

Location

Sismanoglio Hospital

Athens, Greece

Location

University Hospital of Patras

Pátrai, Greece

Location

"Tzanio" Hospital

Piraeus, Greece

Location

AHEPA Hospital

Thessaloniki, Greece

Location

Fondazione S. Raffaele del Monte Tabor

Milan, Italy

Location

Ospedale Amedeo di Savoia

Torino, Italy

Location

OLVG

Amsterdam, Netherlands

Location

Slotervaart Hospital

Amsterdam, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Medical Centre Haaglanden

The Hague, Netherlands

Location

Hospital Condes Castro Guimarães

Cascais, Portugal

Location

Hospitais da Universidade de Coimbra

Coimbra, Portugal

Location

Department of Infeccious Diseases

Lisbon, Portugal

Location

Hospital de São João

Porto, Portugal

Location

Universitätsspital Basel

Basel, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Royal Free Hospital

London, United Kingdom

Location

SSAT/Crusaid Institute

London, United Kingdom

Location

St Mary's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; Ritonavir; Saquinavir; amprenavir; Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines; Pyrimidinones; Pyrimidines

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2003
• First Posted: March 21, 2003
• Study Start: February 18, 2003
• Primary Completion: January 27, 2004
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

BE (3); CA (7); NL (4); GB (3); IT (2); CH (3); PT (4); AU (2); DK (3); US (34); FR (14); DE (21); GR (9)