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.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00933205
First received: July 3, 2009
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The purpose of this Open Label Safety Study is to provide early access to and assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mgTPV/200 mg RTV BID) in HIV-1 infected patients which are triple antiretroviral class experienced with at least two previous PI-containing regimens.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Tipranavir |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Open Label Safety Study o Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933205
Show 215 Study Locations
Show 215 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
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No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00933205 History of Changes |
| Other Study ID Numbers: | 1182.16 |
| Study First Received: | July 3, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | 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 Denmark: Finland: Great Britain: Greece: National Organization of Medicines Ireland: Italy: Ethics Committee Netherlands: Dutch Health Care Inspectorate Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Tipranavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013