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3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00275444
First received: January 9, 2006
Last updated: November 4, 2013
Last verified: November 2013

January 9, 2006
November 4, 2013
March 2002
January 2003   (final data collection date for primary outcome measure)
Virologic response after 2 weeks of functional monotherapy
Same as current
Complete list of historical versions of study NCT00275444 on ClinicalTrials.gov Archive Site
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Same as current
Not Provided
Not Provided
 
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Tipranavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
Not Provided
January 2003   (final data collection date for primary outcome measure)
Not Provided
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00275444
1182.52
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
November 2013

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