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

Expanded access is currently available for this treatment.

Verified February 2012 by Boehringer Ingelheim Pharmaceuticals

First Received on June 10, 2003. Last Updated on February 8, 2012 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tipranavir

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Study Start Date:	April 2003
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Tipranavir 250 mg soft elastic capsules

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 Call Center

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 Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00062660 History of Changes
Other Study ID Numbers:	1182.58
Study First Received:	June 10, 2003
Last Updated:	February 8, 2012
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Disease Attributes
Pathologic Processes
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012