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

Expanded access is currently available for this treatment.

Verified by Boehringer Ingelheim Pharmaceuticals, November 2009

First Received: June 10, 2003 Last Updated: November 23, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tipranavir

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Study Start Date:	May 2003
Estimated Primary Completion Date:	December 2010 (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.

Contacts and Locations

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

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 141 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1182.58
Study First Received:	June 10, 2003
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00062660 History of Changes
Health Authority:	Australia:; Austria: Federal Ministry for Health and Women; Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada; Denmark: The Ministry of the Interior and Health; France: Ministry of Health; Great Britain:; Ireland: Ministry of Health; Italy: Ministry of Health; Netherlands: Ministry of Health, Welfare and Sport; Portugal: National Pharmacy and Medicines Institute; Romania: Ministry of Public Health; South Africa:; Spain: Ministry of Health; Switzerland: Federal Office of Public Health; United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Disease Attributes
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Tipranavir
Virus Diseases
Pathologic Processes
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Emergencies
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009