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

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

Expanded access is currently available for this treatment.
Verified by Boehringer Ingelheim Pharmaceuticals, July 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

ChemIDplus related topics:

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

Intervention Details:

250mg TPV/r caps.BID p.o.

375/150mg/m? TPV/r Oral Solution p.o.

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:

Contacts and Locations

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

Contacts


Contact: Boehringer Ingelheim Study Coordinator		clintriage@boehringer-ingelheim.com

Show 127 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
First Received:	June 10, 2003
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00062660
Health Authority:	United States: Food and Drug Administration; Sweden:; Spain:; Portugal:; Netherlands:; Italy:; Greece:; Germany:; France:; Denmark:; Canada:; Belgium:; Australia:; Great Britain:; Switzerland:; Austria:; Austria:

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 August 27, 2008