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Fosamprenavir Expanded Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240552
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: fosamprenavir Drug: Telzir® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Official Title: An Open-label Phase III Study to Provide Access to Fosamprenavir and to Assess the Long Term Safety and Tolerability of Fosamprenavir Containing Regimens in HIV Infected Patients With Limited Treatment Options
Study Start Date : July 2003
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Drug: fosamprenavir
  • Drug: Telzir®
    Other Name: fosamprenavir



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected subjects.
  • Subjects must belong to one of the following populations:

    1. Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs.
    2. Subjects who already receive amprenavir (Agenerase®)
    3. Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240552


Locations
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Switzerland
GSK Investigational Site
Aarau, Switzerland, 5001
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
Bruderholz, Switzerland, 4101
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
GSK Investigational Site
Lausanne, Switzerland, 1011
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Luzern, Switzerland, 6000
GSK Investigational Site
St Gallen, Switzerland, 9007
GSK Investigational Site
Zurich, Switzerland, 8008
GSK Investigational Site
Zurich, Switzerland, 8038
GSK Investigational Site
Zurich, Switzerland, 8091
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00240552    
Other Study ID Numbers: APV40005
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Keywords provided by ViiV Healthcare:
protease inhibitor
Treatment Experienced
amprenavir
fosamprenavir
GW433908
HIV
pro drug
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents