Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection

Expanded access is currently available for this treatment.
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00062660
First received: June 10, 2003
Last updated: July 9, 2014
Last verified: July 2014

June 10, 2003
July 9, 2014
May 2003
April 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00062660 on ClinicalTrials.gov Archive Site
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Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options

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.

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Expanded Access
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HIV Infections
Drug: Tipranavir
Tipranavir 250 mg soft elastic capsules
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
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April 2014
April 2014   (final data collection date for primary outcome measure)

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.

Both
2 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   Australia,   Belgium,   Denmark,   France,   Greece,   Ireland,   Italy,   Portugal,   South Africa,   Switzerland,   United Kingdom
 
NCT00062660
1182.58
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP