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

Expanded access is currently available for this treatment.

Verified by Boehringer Ingelheim Pharmaceuticals, December 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00062660

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Tipranavir Capsules Drug: Tipranavir Oral Solution

MedlinePlus related topics: AIDS

Drug Information available for: Tipranavir

U.S. FDA Resources

Study Type:	Expanded Access
Official Title:	Emergency Use Program for Highly Treatment-Experienced HIV+ Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Study Start Date:	May 2003
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062660

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 140 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1182.58
Study First Received:	June 10, 2003
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00062660
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Portugal: INFARMED I.P.; United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome

Emergencies
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Disease Attributes
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Infection

Antiviral Agents
Pharmacologic Actions
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009