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

Tracking Information

First Received Date ^ICMJE

June 10, 2003

Last Updated Date

October 12, 2009

Start Date ^ICMJE

May 2003

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

HIV Infections [ Time Frame: n-a ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00062660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Expanded Access

Study Design ^ICMJE

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Tipranavir Capsules
Drug: Tipranavir Oral Solution

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Available

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Location Countries ^ICMJE

United States, Australia, Belgium, Denmark, France, Greece, Ireland, Italy, Portugal, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00062660

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

1182.58

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP