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
  Purpose

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)
  Eligibility

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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

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:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014