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

Expanded access is currently available for this treatment.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00062660
First received: June 10, 2003
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

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 Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tipranavir
    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: May 15, 2013
Health Authority: Australia: Human Research Ethics Committee
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: Medicines Control Council
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 May 19, 2013