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

November 9, 2007 updated by: GlaxoSmithKline

A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • GSK Clinical Trials Call Center
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • GSK Clinical Trials Call Center
  • Belgium
      • Brussels, Belgium, 1000
        • GSK Clinical Trials Call Center
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • GSK Clinical Trials Call Center
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • GSK Clinical Trials Call Center
      • Ottawa, Ontario, Canada, K1N 6N5
        • GSK Clinical Trials Call Center
      • Toronto, Ontario, Canada, M4T 3A7
        • GSK Clinical Trials Call Center
      • Toronto, Ontario, Canada, M5B 1L6
        • GSK Clinical Trials Call Center
    • Quebec
      • Montreal, Quebec, Canada, H2L 5B1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H3G 1A4
        • GSK Clinical Trials Call Center
      • Saint-Foy, Quebec, Canada, G1V 4G2
        • GSK Clinical Trials Call Center
  • France
      • Lagny sur Marne, France, 77400
        • GSK Clinical Trials Call Center
      • Paris, France, 75475
        • GSK Clinical Trials Call Center
      • Paris, France, 75970
        • GSK Clinical Trials Call Center
      • Paris, France, 93009
        • GSK Clinical Trials Call Centre
      • Saint Denis, France, 93205
        • GSK Clinical Trials Call Center
      • Strasburg, France, 67000
        • GSK Clinical Trials Call Center
      • Toulon, France, 83000
        • GSK Clinical Trials Call Center
      • Vanouvre Les Nancy, France, 54511
        • GSK Clinical Trials Call Center
  • Germany
      • Hamburg, Germany, 20095
        • GSK Clinical Trials Call Center
  • Greece
      • Athens, Greece, 10676
        • GSK Clinical Trials Call Center
      • Athens, Greece, 11526
        • GSK Clinical Trials Call Center
      • Athens, Greece, 11527
        • GSK Clinical Trials Call Center
      • Piraeus, Greece, 18536
        • GSK Clinical Trials Call Center
  • Italy
      • Liguria, Italy, 16128
        • GSK Clinical Trials Call Center
      • Lombardia, Italy, 27100
        • GSK Clinical Trials Call Center
      • Romagna, Italy, 44100
        • GSK Clinical Trials Call Center
      • Rome, Italy, 00 168
        • GSK Clinical Trials Call Center
      • Torino, Italy, 10149
        • GSK Clinical Trials Call Centre
      • Toscana, Italy, 50126
        • GSK Clinical Trials Call Center
      • Toscana, Italy, 50139
        • GSK Clinical Trials Call Center
      • Veneto, Italy, 35128
        • GSK Clinical Trials Call Center
  • Spain
      • Barcelona, Spain, 8025
        • GSK Clinical Trials Call Center
      • Jerez de la Frontera, Spain, 11407
        • GSK Clinical Trials Call Center
      • Madrid, Spain, 28029
        • GSK Clinical Trials Call Center
      • Madrid, Spain, 28040
        • GSK Clinical Trials Call Center
      • Madrid, Spain, 28041
        • GSK Clinical Trials Call Center
  • United Kingdom
      • Birmingham, United Kingdom, B29 JD6
        • GSK Clinical Trials Call Center
      • Brighton, United Kingdom, BN2 3EW
        • GSK Clinical Trials Call Center
      • London, United Kingdom, EC1A 7BE
        • GSK Clinical Trials Call Center
      • London, United Kingdom, NW3 2QG
        • GSK Clinical Trials Call Center
      • London, United Kingdom, SE5 9RS
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Application of additional exclusion criteria as determined by physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APV102002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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