An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

• Conditions: HIV Infections

• Registration Number: NCT00933205
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2008-06
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Status Verified: 2013-10
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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.
2. Age equal or more than 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 which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.

5. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation

6. 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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (215)

1182.16.3202 Boehringer Ingelheim Investigational Site; 🇧🇪 Antwerpen, Belgium

1182.16.3203 Boehringer Ingelheim Investigational Site; 🇧🇪 Brussel, Belgium

1182.16.3205 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1182.16.3206 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1182.16.3207 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1182.16.3211 Boehringer Ingelheim Investigational Site; 🇧🇪 Charleroi, Belgium

1182.16.3204 Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium

1182.16.3201 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium

1182.16.3208 Boehringer Ingelheim Investigational Site; 🇧🇪 Liège, Belgium

1182.16.3212 Boehringer Ingelheim Investigational Site; 🇧🇪 Liège, Belgium

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