Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

March 19, 2003

Last Updated Date

August 28, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00056641 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial

Official Title ^ICMJE

An Open Label, Randomised, Parallel Group Pharmacokinetics Trial of TPV/RTV Alone or in Combination With RTV-Boosted SQV, APV or LPV, Plus an OBR in Multiple ARV Experienced Patients.

Brief Summary

This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: tipranavir
Drug: ritonavir
Drug: saquinavir
Drug: amprenavir
Drug: lopinavir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

328

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00056641

Responsible Party

Study ID Numbers ^ICMJE

1182.51

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

June 2008

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