Clinical trial NCT00144287: Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
Official title: An Open Label Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir (TVP/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

The safety assessment will be performed by evaluating:

* The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
* The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.

The efficacy assessment will be performed by evaluating:

* The quantity of HIV-1 RNA
* The CD4 cell count.

Study Hypothesis:

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

Comparison(s):

N.A.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Age \>= 18 years
3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
4. Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion Criteria:

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
2. Required use of restricted medications
3. Female patients of childbearing potential who:

   * Have a positive pregnancy test at baseline or
   * Are breast feeding.
4. 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.
5. Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
6. 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.

Primary outcomes:
measure: The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
measure: The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash
Secondary outcomes:
measure: The quantity of HIV-1 RNA
measure: The CD4 cell count
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Epimed GmbH
city: Berlin
country: Germany
facility: Universitätskliniken Charité
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum
city: Bonn
country: Germany
facility: Medizinische Universitätsklinik Bonn
city: Dortmund
country: Germany
facility: Klinikum Dortmund g GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen-Nürnberg
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Klinikum der J.-W.-Goethe-Universität
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Giessen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
city: Hamburg
country: Germany
facility: ifi Institut für Interdisziplinäre Infektiologie
city: Hamburg
country: Germany
facility: IPM Study Center GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: Med. Hochschule Hannover
city: Homburg/Saar
country: Germany
facility: Universitätsklinik des Saarlandes
city: Kiel
country: Germany
facility: Universitätsklinikum im
city: Koblenz
country: Germany
facility: Städtisches Krankenhaus Kemperhof
city: Köln
country: Germany
facility: Krankenhaus der
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Universitätsklinik Köln
city: Leipzig
country: Germany
facility: Städtisches Klinikum St. Georg
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität Mainz
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Medizinische Poliklinik
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: Klinik und Poliklinik für Neurologie
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oldenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: Klinium Natruper Holz
city: Salzgitter
country: Germany
facility: Klinikum Salzgitter GmbH
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: Medizinische Universitätsklinik Ulm
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: B.I. Pharma GmbH & Co. KG
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: