Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

NCT00144287 | Completed Phase 3

• 1 other identifier: 1182.68
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 53

Brief Summary

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters

• The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash

Secondary Outcomes (2)

• The quantity of HIV-1 RNA

• The CD4 cell count

Interventions

Tipranavir/Ritonavir DRUG

Eligibility Criteria

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

You may qualify if:

• Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
• Age \>= 18 years
• Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
• Patient voluntarily provides written informed consent to participate, in compliance with local law

You may not qualify if:

• Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
• Required use of restricted medications
• Female patients of childbearing potential who:
• Have a positive pregnancy test at baseline or
• Are breast feeding.
• Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
• Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
• Hepatic impairment(\*) evidenced by the following baseline laboratory findings:
• AST or ALT \>5X upper limit of normal (ULN) or total bilirubin \>3.5X ULN or
• AST or ALT \>2.5X ULN and total bilirubin \>2X ULN
• (\*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

Boehringer Ingelheim Investigational Site

Aachen, 52062, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10117, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10243, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10439, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10627, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10707, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10719, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10777, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10961, Germany

Location

Epimed GmbH

Berlin, 12157, Germany

Location

Universitätskliniken Charité

Berlin, 12203, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 13347, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 14057, Germany

Location

Klinikum der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Medizinische Universitätsklinik Bonn

Bonn, 53105, Germany

Location

Krankenhaus der

Cologne, 50678, Germany

Location

Boehringer Ingelheim Investigational Site

Cologne, 50679, Germany

Location

Boehringer Ingelheim Investigational Site

Cologne, 50735, Germany

Location

Universitätsklinik Köln

Cologne, 50924, Germany

Location

Klinikum Dortmund g GmbH

Dortmund, 44137, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Boehringer Ingelheim Investigational Site

Duisburg, 47055, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Boehringer Ingelheim Investigational Site

Düsseldorf, 40237, Germany

Location

Universitätsklinik Erlangen-Nürnberg

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der J.-W.-Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, 79098, Germany

Location

Klinikum der Justus-Liebig-Universität

Giessen, 35392, Germany

Location

ifi Institut für Interdisziplinäre Infektiologie

Hamburg, 20099, Germany

Location

IPM Study Center GmbH

Hamburg, 20146, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Boehringer Ingelheim Investigational Site

Hanover, 30159, Germany

Location

Med. Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinik des Saarlandes

Homburg/Saar, 66421, Germany

Location

Universitätsklinikum im

Kiel, 24116, Germany

Location

Städtisches Krankenhaus Kemperhof

Koblenz, 56065, Germany

Location

Städtisches Klinikum St. Georg

Leipzig, 04129, Germany

Location

Johannes-Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Boehringer Ingelheim Investigational Site

München, 80335, Germany

Location

Medizinische Poliklinik

München, 80336, Germany

Location

Boehringer Ingelheim Investigational Site

München, 80801, Germany

Location

Boehringer Ingelheim Investigational Site

München, 81669, Germany

Location

Boehringer Ingelheim Investigational Site

Münster, 48143, Germany

Location

Boehringer Ingelheim Investigational Site

Münster, 48149, Germany

Location

Klinik und Poliklinik für Neurologie

Münster, 48149, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90461, Germany

Location

Boehringer Ingelheim Investigational Site

Oldenburg, 28121, Germany

Location

Klinium Natruper Holz

Osnabrück, 49090, Germany

Location

Klinikum Salzgitter GmbH

Salzgitter, 38226, Germany

Location

Boehringer Ingelheim Investigational Site

Stuttgart, 70197, Germany

Location

Medizinische Universitätsklinik Ulm

Ulm, 89070, Germany

Location

Boehringer Ingelheim Investigational Site

Wuppertal, 42277, Germany

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; Ritonavir

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

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Pharma GmbH & Co. KG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

DE (53)