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Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects

NCT ID: NCT00144833

Last Updated: 2007-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.

Detailed Description

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Conditions

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HIV-1

Keywords

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Protease inhibitors-experienced HIV-1 infected patients Highly-resistant HIV-1 Dual boosted Pis fosamprenavir lopinavir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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fosamprenavir/ritonavir (700mg/100mg BID)

Intervention Type DRUG

fosamprenavir/ritonavir (1400mg/100mg BID)

Intervention Type DRUG

fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests.

Exclusion Criteria

* No full resistance to FPV/r or LPV/r
* Planned use of NNRTIs as part of the study salvage regimen
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Darlinghurst, New South Wales, Australia

Site Status

GSK Clinical Trials Call Center

Carlton, Victoria, Australia

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GSK Clinical Trials Call Center

Brussels, , Belgium

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GSK Clinical Trials Call Center

Vancouver, British Columbia, Canada

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GSK Clinical Trials Call Center

Hamilton, Ontario, Canada

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GSK Clinical Trials Call Center

Ottawa, Ontario, Canada

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GSK Clinical Trials Call Center

Toronto, Ontario, Canada

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GSK Clinical Trials Call Center

Toronto, Ontario, Canada

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GSK Clinical Trials Call Center

Montreal, Quebec, Canada

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GSK Clinical Trials Call Center

Montreal, Quebec, Canada

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GSK Clinical Trials Call Center

Saint-Foy, Quebec, Canada

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GSK Clinical Trials Call Center

Lagny-sur-Marne, , France

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GSK Clinical Trials Call Center

Paris, , France

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GSK Clinical Trials Call Center

Paris, , France

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GSK Clinical Trials Call Centre

Paris, , France

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GSK Clinical Trials Call Center

Saint-Denis, , France

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GSK Clinical Trials Call Center

Strasbourg, , France

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GSK Clinical Trials Call Center

Toulon, , France

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GSK Clinical Trials Call Center

Vanouvre Les Nancy, , France

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GSK Clinical Trials Call Center

Hamburg, , Germany

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GSK Clinical Trials Call Center

Athens, , Greece

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GSK Clinical Trials Call Center

Athens, , Greece

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GSK Clinical Trials Call Center

Athens, , Greece

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GSK Clinical Trials Call Center

Piraeus, , Greece

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GSK Clinical Trials Call Center

Liguria, , Italy

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GSK Clinical Trials Call Center

Lombardia, , Italy

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GSK Clinical Trials Call Center

Romagna, , Italy

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GSK Clinical Trials Call Center

Rome, , Italy

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GSK Clinical Trials Call Centre

Torino, , Italy

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GSK Clinical Trials Call Center

Toscana, , Italy

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GSK Clinical Trials Call Center

Toscana, , Italy

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GSK Clinical Trials Call Center

Veneto, , Italy

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GSK Clinical Trials Call Center

Barcelona, , Spain

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GSK Clinical Trials Call Center

Jerez de la Frontera, , Spain

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GSK Clinical Trials Call Center

Madrid, , Spain

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GSK Clinical Trials Call Center

Madrid, , Spain

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GSK Clinical Trials Call Center

Madrid, , Spain

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GSK Clinical Trials call Center

Birmingham, , United Kingdom

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GSK Clinical Trials Call Center

Brighton, , United Kingdom

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GSK Clinical Trials Call Center

London, , United Kingdom

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GSK Clinical Trials Call Center

London, , United Kingdom

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GSK Clinical Trials Call Center

London, , United Kingdom

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Countries

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Australia Belgium Canada France Germany Greece Italy Spain United Kingdom

Other Identifiers

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APV102002

Identifier Type: -

Identifier Source: org_study_id