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

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

Condition Intervention Phase
HIV Infections
Drug: Tipranavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Virologic response after 2 weeks of functional monotherapy

Secondary Outcome Measures:
  • Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.

Enrollment: 216
Study Start Date: March 2002
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00275444

  Show 62 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00275444     History of Changes
Other Study ID Numbers: 1182.52 
Study First Received: January 9, 2006
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on May 26, 2016