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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.