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Emergency Use Program for HTE HIV+ Patients Who Need Tipranavir Treatment

Expanded access is currently available for this treatment.
Study NCT00062660.   Last updated on July 1, 2008.   Information provided by Boehringer Ingelheim Pharmaceuticals

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Descriptive Information Fields
Brief Title  Emergency Use Program for HTE HIV+ Patients Who Need Tipranavir Treatment
Official Title  Emergency Use Program for Highly Treatment-Experienced HIV+ Patients
Brief Summary

To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.

Detailed Description
Study Phase
Study Type  Expanded Access
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Tipranavir Capsules
Drug: Tipranavir Oral Solution
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Available
Enrollment 
Start Date  April 2003
Completion Date
Eligibility Criteria 

Inclusion Criteria:

Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to multiple protease inhibitors.

Exclusion Criteria:

Gender Both
Ages 2 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Boehringer Ingelheim Study Coordinator         clintriage@boehringer-ingelheim.com    
Location Countries  United States,   Australia,   Belgium,   Denmark,   France,   Italy,   Portugal,   Switzerland,   United Kingdom
Administrative Information Fields
NCT ID  NCT00062660
Organization ID 1182.58
Secondary IDs ††
Study Sponsor  Boehringer Ingelheim Pharmaceuticals
Collaborators ††
Investigators 
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
Information Provided By Boehringer Ingelheim Pharmaceuticals
Verification Date July 2008
First Received Date  June 10, 2003
Last Updated Date July 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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