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

This study has been completed.

First Received: March 19, 2003 Last Updated: August 28, 2008 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00056641

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: tipranavir Drug: ritonavir Drug: saquinavir Drug: amprenavir Drug: lopinavir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Ritonavir VX 478 Tipranavir Lopinavir

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment:	328
Study Start Date:	January 2003
Estimated Study Completion Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056641

Show 109 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	1182.51
Study First Received:	March 19, 2003
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00056641 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Infection
Tipranavir
Anti-Bacterial Agents
Amprenavir
Lopinavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on November 22, 2009