Trial record 20 of 32 for:
" June 10, 2009":" July 10, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Expanded access is no longer available for this treatment.
Information provided by:
First received: July 3, 2009
Last updated: October 30, 2013
Last verified: October 2013
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.
What is Expanded Access?
||An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
| Study Start Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments.
- Age equal or more than 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.
- 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 which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.
- Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
Hepatic impairment evidenced by the following baseline laboratory findings:
- AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN
- AST or ALT more 2.5X ULN and total bilirubin more 2X ULN
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933205
No publications provided
||Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 3, 2009
||October 30, 2013
||Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products Department R&D EUROSTATION, Bloc II Place Victor Horta, 40 bte 40 - 8ème étage 1060 Bruxelles Belgium
Brazil: National Health Surveillance Agency
Canada: Ethics Review Committee
Greece: National Organization of Medicines
Italy: Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 12, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action