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

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ClinicalTrials.gov Identifier: NCT00275444
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : November 5, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Tipranavir Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2002
Actual Primary Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tipranavir
U.S. FDA Resources




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275444


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

ClinicalTrials.gov Identifier: NCT00275444     History of Changes
Other Study ID Numbers: 1182.52
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents